The Experts below are selected from a list of 177 Experts worldwide ranked by ideXlab platform
Philip T. Hackney - One of the best experts on this subject based on the ideXlab platform.
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Political Justice and Tax Policy: The Social Welfare Organization Case
Texas A&M Law Review, 2021Co-Authors: Philip T. HackneyAbstract:In addition to valuing whether a tax policy is equitable, efficient, and administrable, I argue we should ask if a tax policy is politically just. Others have made a similar case for valuing political justice as democracy in implementing just tax policy. I join that call and highlight why it matters in one arena—tax exemption. I also further that discussion by arguing that politically just tax policy does the least harm to the democratic functioning of our government and may ideally enhance it. I argue that our right to an equal voice in collective decision-making is the most fundamental value of political justice. To test this case, I evaluate our choice to exempt “social Welfare Organizations” from the U.S. income tax. In addition to efficiency and equity, I also ask whether the policy is politically just in a democratic sense. I examine three models of democratic justice: liberal, republican, and deliberative. In making the democratic case, I try to find commonalities among the three in order to further what an agreed upon notion of democratic justice might look like in the tax context. I contend that the notion of democratic justice must exist at the substantive level of the Internal Revenue Code (“Code”). This Code-level application demonstrates that the typical criteria of efficiency and fairness do not provide sufficient criteria to evaluate the justice of tax-exempt policy. Political justice provides additional important evaluative criteria. There are likely significant other parts of income tax policy that need to be considered from the value of political justice as democracy as well.
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a response to professor leff s tax planning olive branch for marijuana dealers
Social Science Research Network, 2013Co-Authors: Philip T. HackneyAbstract:Professor Benjamin Leff argues in a forthcoming article entitled Tax Planning for Marijuana Dealers that a tax-exempt social Welfare Organization described in Internal Revenue Code section 501(c)(4) may sell medical marijuana without putting its exempt status in jeopardy. He argues that (1) the “public policy” doctrine applicable to charitable Organizations under section 501(c)(3) does not apply to social Welfare Organizations, and (2) a social Welfare Organization may consider “community” law and ignore federal law in considering whether its activity meets the idea of social Welfare. I argue that Leff is wrong and that the public policy doctrine applicable to charitable Organizations applies to social Welfare Organizations equally. Tax-exempt Organizations derive exempt status primarily by supplying significant public benefits. Violating federal, state or local law causes public harm; thus, any tax-exempt Organization, including a social Welfare Organization, may not violate established public policy as a substantial purpose. Additionally, the “community” requirement for social Welfare Organizations is to ensure the Organization is dedicated to a public purpose rather than a private one. Violating any law, including federal, is more likely to ensure an Organization is operating for a private rather than public purpose. Contrary to Leff’s claim therefore, this article argues that a social Welfare Organization may not sell medical marijuana and maintain its exempt status.
Nighat Majeed - One of the best experts on this subject based on the ideXlab platform.
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therapeutic efficacy of honey and nigella sativa against covid 19 a multi center randomized controlled clinical trial hns covid pk
medRxiv, 2020Co-Authors: Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Muhammad Imran, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Nighat Majeed, Iqra Farooq, Zaigham HabibAbstract:BACKGROUND: COVID-19 has caused havoc across the globe since, no specific treatment exists for this disease, thus, far. Hence, there is an urgent need to find an effective treatment to mitigate this scourge. Honey and Nigella sativa are two natural substances with anti-inflammatory, anti-viral, anti-microbial and immune modulating properties. They could be potentially beneficial in these patients. METHODS: We conducted an add-on, randomized, open label, placebo-controlled clinical trial using parallel group design. This was a multi-centered study with superiority framework conducted in RT-PCR confirmed COVID-19 patients showing moderate or severe disease. All patients receiving standard care were randomized into treatment and control groups. In the treatment arm, patients received HNS (honey plus Nigella sativa) in predefined doses for up to 13 days. The primary outcome measures (time taken for alleviation of symptoms, viral clearance and clinical status improvement on day 6) outcomes were assessed. RESULTS: Of 1046 patients testing positive for the SARS-CoV-2, 210 showing moderate and 103 showing severe disease were randomized into treatment and control groups as per inclusion criteria. In the moderate cases, 107 were assigned to the HNS group and 103 to the control group. Among 103 severe cases, 50 were assigned to the HNS group and 53 to the control group. In the moderate and severe cases, the HNS treatment was associated with a normalized median symptoms alleviation time reduction of 3 and 7 days (HR: 6.11; 95% CI: 4.23-8.84 and HR: 4.04; 95% CI, 2.46-6.64) respectively. The HNS treatment in both groups were further associated with 4 days earlier reduction in median viral clearance time (Moderate HR: 5.53; 95% CI: 3.76-8.14) and Severe HR: 4.32; 95% CI: 2.62-7.13). Moreover, in the intention-to-treat analysis, the HNS groups led to a lower (better) clinical score on day 6 with resumption of normal activity among 63.6% of the moderate (OR: 0.07; 95% CI: 0.03-0.13) and 28% of severe cases (OR: 0.03; 95% CI: 0.01-0.09). Furthermore, a significant (14.87%) reduction (OR: 0.18; 95% CI: 0.02-0.92) in mortality was observed in the HNS arm. No difference in adverse effects were seen between the HNS and control arms. CONCLUSIONS: A significant reduction in in the severity of disease, the time taken for viral clearance and mortality was observed with HNS treatment in COVID-19 patients. HNS represents a safe, effective, over the counter and affordable therapy for this pandemic essentially lowering health care burden. It can be used alone or in combination with other expensive treatments and give an additive effect. Hence, the potential of HNS against COVID-19 should be explored in future larger studies. (Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences; NIH Clinical Trial Register number: [NCT04347382][1].) ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04347382 ### Funding Statement Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: IRB Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan approval ID SZH/IRB/0026/2020 and IRB Services Institute of Medical Sciences, Lahore, Pakistan approval ID IRB/2020/658/SIMS All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Clinical data is available as additional file and raw data can be provided on request to corresponding author [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04347382&atom=%2Fmedrxiv%2Fearly%2F2020%2F11%2F03%2F2020.10.30.20217364.atom
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honey and nigella sativa against covid 19 in pakistan hns covid pk a multi center placebo controlled randomized clinical trial
medRxiv, 2020Co-Authors: Sohaib Ashraf, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Iqra Farooq, Zaigham Habib, M H Ashraf, M A Imran, M Akram, Nighat MajeedAbstract:BACKGROUND: No definitive treatment exists for Coronavirus Disease 2019 (COVID-19). Honey and Nigella sativa (HNS) have established antiviral properties. Hence, we investigated the efficacy of HNS against COVID-19. METHODS: We conducted a multicenter, placebo-controlled, randomized clinical trial at 4 centers in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive either honey (1 gm/Kg/day) and Nigella sativa seeds (80 mg/Kg/day) or placebo up-to 13 days along with standard care. The outcomes included symptom alleviation, viral clearance, and 30-day mortality in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT04347382. FINDINGS Three hundred and thirteen patients - 210 moderate and 103 severe - underwent randomization from April 30 to July 29, 2020. Among these, 107 were assigned to HNS whereas 103 to placebo for moderate cases. For severe cases, 50 were given HNS, and 53 were given placebos. HNS resulted in ~50% reduction in time taken to alleviate symptoms as compared to placebo (Moderate (4 versus 7 days), Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, P<0.0001 and severe (6 versus 13 days) HR: 4.04; 95% CI, 2.46-6.64, P<0.0001). HNS also cleared the virus 4 days earlier than the placebo group in moderate (6 versus 10 days, HR: 5.53; 95% CI: 3.76-8.14, P<0.0001) and severe cases (8.5 versus 12 days, HR: 4.32; 95% CI: 2.62-7.13, P<0.0001). HNS further led to a better clinical score on day 6 with normal activity resumption in 63.6% versus 10.9% among moderate cases (OR: 0.07; 95% CI: 0.03-0.13, P<0.0001) and hospital discharge in 50% versus 2.8% in severe cases (OR: 0.03; 95% CI: 0.01-0.09, P<0.0001). In severe cases, mortality rate was four-fold lower in HNS group than placebo (4% versus 18.87%, OR: 0.18; 95% CI: 0.02-0.92, P=0.029). No HNS-related adverse effects were observed. INTERPRETATION HNS significantly improved symptoms, viral clearance, and mortality in COVID-19 patients. Thus, HNS represents an affordable over the counter therapy and can either be used alone or in combination with other treatments to achieve potentiating effects against COVID-19. FUNDING: Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex, and Services Institute of Medical Sciences.
Sharif Usman - One of the best experts on this subject based on the ideXlab platform.
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How do firms use corporate social responsibiblity to build brand equity
Universitetet i Agder ; University of Agder, 2012Co-Authors: Sharif UsmanAbstract:Masteroppgave i økonomi og administrasjon - Universitetet i Agder 2012Corporate Citizenship, Corporate Conscience, Social Performance and Sustainable Responsible Business are the different names of Corporate Social Responsibility. It is a self-regulating mechanism whereby companies take account of social norms and local laws of country. This term came alive around 1960s and 1970s. The core objective of CSR is to increase the responsibility by the firm towards environment, health and safety, labor, consumers, communities etc. The Stakeholder Theory given by the Freeman and UN Global Compact are the founding principles of investing in CSR. To become socially responsible has become an ultimate part of company‟s objectives. The CSR got different approaches that one company can follow. It all depends on their strategy, seriousness as well as their mindset. One of the approach is giving donation to some particular sector, NGO or any public Welfare Organization. It becomes the part of their value creation strategy. Few companies used different approach like making CSR a part of their core strategy and heavily investing resources like Coca-Cola made Coca-Cola foundation. Shell and Nike are working with many NGOs in different Welfare projects. Some companies use benchmarking strategy like the way their competitors are doing, they do the same. Companies are socially accountable and responsible for their internal as well as external acts. They are not allowed to do any act which is against the local norms, laws, regulations or against environment. CSR is a name of consistent and true commitment to behave ethically and take part in the development of economic growth and improving quality of life. There is a strong connection between brand equity and CSR. Being a socially responsible by using any approach makes a bridge in between CSR and brand equity. The question is how it creates a bridge and at what extent brand equity based on CSR? How CSR can enhance brand equity and how it creates a positive image in the minds of all the stakeholders? There is a strong connection in between CSR and brand equity. Brand equity is an association that develops among people and brands. It spreads on different levels and companies strive hard to consistently building brand equity. The majority conventional feature of brand equity is brand relationship. Associations symbolize the basis for brand devotion and for purchase choice. Brand equity is considered to be the customer loyalty, brand‟s potential price premium, alleged brand leadership, high comparative quality, differ from other brands, consumers‟ perceived trust, admiration and reliability of the brand, brand awareness, the alleged worth of the brand, its market share, its character as well as its functional advantages. Different literatures reviewed to know and understand the basics of these two concepts and what are the areas under CSR that companies explored so far. Corporate Citizenship defines the companies‟ sense of accountability towards the society and the surroundings and environment in which it functions, and illustrates possessions and takes sustenance from. Stakeholders or the citizens who influence or are exaggerated by communal strategies and performances are the focal points, and the director is leaning toward these focal points. Corporate Social Responsibility, in order to explain the condition by categorizing the main hypothesis as well as the approaches into four groups that are economical, political, communal incorporation as well as morals or principles. The Freeman‟s Stakeholder theory is also reviewed in detail in order to analyze its impact over the CSR and ultimately brand equity. Managing and integrating the relationships among stakeholders like employees, suppliers, communities and shareholders is the main objective of the Stakeholders‟ Theory that imposes a positive impact on the long-term growth of a firm. The word “stockholder” is clearly influenced by the stakeholder approach. International Standard Organization and UN Global Compact have given standards that one company may follow to achieve goodwill among all the stakeholders. In fact, it helped companies to see the loopholes and aftereffects of CSR initiatives. The ten principles of UN Global Compact under the heads of environment, labor, human resource, anti-corruption, local communities are evidently helping companies to achieve their objectives. We have focused on three main variables in this study which are; environment, labor and local communities. These three variables are clearly defined in both the mentioned documents. It has clearly written that companies must follow the local as well as international environment laws. They must develop health and safe working environment for their employees. Production hazards and inefficiencies must be minimized. Employees must have full liberty in terms of freedom of association, freedom of speech and exiting. There should be no biasness during the recruitment and companies must eliminate discrimination of employees. The role of companies and state become extremely important to avoid the circumstances of slavery, child labor, physical abduction, bonded labor, threats to labor, non-payment of wages, deprivation of food and shelter, discrimination of employees etc. Age standards in regards to the type of work must be justifiable. Companies like Nike who may have sub-Page | 6 contractors need to ensure the elimination of child labor. The role of local communities and trade unions come in front to make them realize and responsible. Environmentally sound technologies can eliminate day-to-day polluting emissions, operational inefficiencies, waste, workers‟ interaction with hazardous materials etc. It will lead to enhancing productivity standards, less use of raw materials, increase overall competitiveness and provide long-term growth. Shell and Apple in the past few years have changed the face of usage of technology in their production processes. Apple has become the giant in technology world but we need to assure that these companies set clear performance objectives regarding the production and consumption processes and are these sustainable in the long-run and what are the compliance standards? Investing in research and developing environmentally friendly products can surely have significant progressions of progress in the long-run. Different case studies of four companies reviewed and analyzed. It is observed that Coca-Cola and Apple are facing severe allegations related to the violation of environmental and labor laws. The production partners of Nike also found to be involved in child labor. These companies are quite active now in the area of CSR through different initiatives. They observed quite influencing effects of investing resources in CSR initiatives in terms of enhanced brand equity and company‟s image. There are different CSR activities Moreover, it has been experienced by these companies that stakeholders including internal as well external environment, labor, communities, shareholders, suppliers, consumers perceive a better image and give more value to the names of these companies. This study explored number of CSR initiatives taken by these companies and taken out ratings on the basis of these activities. The results shown that almost all the four companies (Shell, Coca-Cola, Apple, Nike) are becoming more socially responsible. Nike has made a strong code of conduct for their suppliers around the world. They are making efforts to implement this code of conduct to eliminate child labor and minimum age limit. Coca-Cola foundation is a part of growth strategy. Coca-Cola made number of initiatives especially in India after receiving huge amount of allegations related to polluting the environment. Apple made efforts to use environment friendly material in their products after the incident of few labors in China production unit. Shell is the leading company in oil and gas sector. Shell must put on more responsibility towards safer and clean environment. They spend huge amount of money on research and development every year in order to avoid any harmful acts. So, we may conclude that companies are getting aware about the importance of CSR. A safer working environment for the labor ensures enhance productivity and commitment towards Organization. Consumers develop a good image of that company who is doing for improving the quality of life and investing in social projects in front of them. Brand equity is somewhat directly proportional to corporate citizenship. The business environment has become quite competitive and companies are gradually accepting the importance of CSR. The objective of focusing only generating more revenue streams is no more valid. This study is being done under the observation of three important variables. There is still room available for exploring the impact of other variables over the brand equity and many uncovered industries may become the next focus
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How do firms use corporate social responsibiblity to build brand equity
Universitetet i Agder ; University of Agder, 2012Co-Authors: Sharif UsmanAbstract:Corporate Citizenship, Corporate Conscience, Social Performance and Sustainable Responsible Business are the different names of Corporate Social Responsibility. It is a self-regulating mechanism whereby companies take account of social norms and local laws of country. This term came alive around 1960s and 1970s. The core objective of CSR is to increase the responsibility by the firm towards environment, health and safety, labor, consumers, communities etc. The Stakeholder Theory given by the Freeman and UN Global Compact are the founding principles of investing in CSR. To become socially responsible has become an ultimate part of company‟s objectives. The CSR got different approaches that one company can follow. It all depends on their strategy, seriousness as well as their mindset. One of the approach is giving donation to some particular sector, NGO or any public Welfare Organization. It becomes the part of their value creation strategy. Few companies used different approach like making CSR a part of their core strategy and heavily investing resources like Coca-Cola made Coca-Cola foundation. Shell and Nike are working with many NGOs in different Welfare projects. Some companies use benchmarking strategy like the way their competitors are doing, they do the same. Companies are socially accountable and responsible for their internal as well as external acts. They are not allowed to do any act which is against the local norms, laws, regulations or against environment. CSR is a name of consistent and true commitment to behave ethically and take part in the development of economic growth and improving quality of life. There is a strong connection between brand equity and CSR. Being a socially responsible by using any approach makes a bridge in between CSR and brand equity. The question is how it creates a bridge and at what extent brand equity based on CSR? How CSR can enhance brand equity and how it creates a positive image in the minds of all the stakeholders? There is a strong connection in between CSR and brand equity. Brand equity is an association that develops among people and brands. It spreads on different levels and companies strive hard to consistently building brand equity. The majority conventional feature of brand equity is brand relationship. Associations symbolize the basis for brand devotion and for purchase choice. Brand equity is considered to be the customer loyalty, brand‟s potential price premium, alleged brand leadership, high comparative quality, differ from other brands, consumers‟ perceived trust, admiration and reliability of the brand, brand awareness, the alleged worth of the brand, its market share, its character as well as its functional advantages. Different literatures reviewed to know and understand the basics of these two concepts and what are the areas under CSR that companies explored so far. Corporate Citizenship defines the companies‟ sense of accountability towards the society and the surroundings and environment in which it functions, and illustrates possessions and takes sustenance from. Stakeholders or the citizens who influence or are exaggerated by communal strategies and performances are the focal points, and the director is leaning toward these focal points. Corporate Social Responsibility, in order to explain the condition by categorizing the main hypothesis as well as the approaches into four groups that are economical, political, communal incorporation as well as morals or principles. The Freeman‟s Stakeholder theory is also reviewed in detail in order to analyze its impact over the CSR and ultimately brand equity. Managing and integrating the relationships among stakeholders like employees, suppliers, communities and shareholders is the main objective of the Stakeholders‟ Theory that imposes a positive impact on the long-term growth of a firm. The word “stockholder” is clearly influenced by the stakeholder approach. International Standard Organization and UN Global Compact have given standards that one company may follow to achieve goodwill among all the stakeholders. In fact, it helped companies to see the loopholes and aftereffects of CSR initiatives. The ten principles of UN Global Compact under the heads of environment, labor, human resource, anti-corruption, local communities are evidently helping companies to achieve their objectives. We have focused on three main variables in this study which are; environment, labor and local communities. These three variables are clearly defined in both the mentioned documents. It has clearly written that companies must follow the local as well as international environment laws. They must develop health and safe working environment for their employees. Production hazards and inefficiencies must be minimized. Employees must have full liberty in terms of freedom of association, freedom of speech and exiting. There should be no biasness during the recruitment and companies must eliminate discrimination of employees. The role of companies and state become extremely important to avoid the circumstances of slavery, child labor, physical abduction, bonded labor, threats to labor, non-payment of wages, deprivation of food and shelter, discrimination of employees etc. Age standards in regards to the type of work must be justifiable. Companies like Nike who may have sub-Page | 6 contractors need to ensure the elimination of child labor. The role of local communities and trade unions come in front to make them realize and responsible. Environmentally sound technologies can eliminate day-to-day polluting emissions, operational inefficiencies, waste, workers‟ interaction with hazardous materials etc. It will lead to enhancing productivity standards, less use of raw materials, increase overall competitiveness and provide long-term growth. Shell and Apple in the past few years have changed the face of usage of technology in their production processes. Apple has become the giant in technology world but we need to assure that these companies set clear performance objectives regarding the production and consumption processes and are these sustainable in the long-run and what are the compliance standards? Investing in research and developing environmentally friendly products can surely have significant progressions of progress in the long-run. Different case studies of four companies reviewed and analyzed. It is observed that Coca-Cola and Apple are facing severe allegations related to the violation of environmental and labor laws. The production partners of Nike also found to be involved in child labor. These companies are quite active now in the area of CSR through different initiatives. They observed quite influencing effects of investing resources in CSR initiatives in terms of enhanced brand equity and company‟s image. There are different CSR activities Moreover, it has been experienced by these companies that stakeholders including internal as well external environment, labor, communities, shareholders, suppliers, consumers perceive a better image and give more value to the names of these companies. This study explored number of CSR initiatives taken by these companies and taken out ratings on the basis of these activities. The results shown that almost all the four companies (Shell, Coca-Cola, Apple, Nike) are becoming more socially responsible. Nike has made a strong code of conduct for their suppliers around the world. They are making efforts to implement this code of conduct to eliminate child labor and minimum age limit. Coca-Cola foundation is a part of growth strategy. Coca-Cola made number of initiatives especially in India after receiving huge amount of allegations related to polluting the environment. Apple made efforts to use environment friendly material in their products after the incident of few labors in China production unit. Shell is the leading company in oil and gas sector. Shell must put on more responsibility towards safer and clean environment. They spend huge amount of money on research and development every year in order to avoid any harmful acts. So, we may conclude that companies are getting aware about the importance of CSR. A safer working environment for the labor ensures enhance productivity and commitment towards Organization. Consumers develop a good image of that company who is doing for improving the quality of life and investing in social projects in front of them. Brand equity is somewhat directly proportional to corporate citizenship. The business environment has become quite competitive and companies are gradually accepting the importance of CSR. The objective of focusing only generating more revenue streams is no more valid. This study is being done under the observation of three important variables. There is still room available for exploring the impact of other variables over the brand equity and many uncovered industries may become the next focus
Zaigham Habib - One of the best experts on this subject based on the ideXlab platform.
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therapeutic efficacy of honey and nigella sativa against covid 19 a multi center randomized controlled clinical trial hns covid pk
medRxiv, 2020Co-Authors: Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Muhammad Imran, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Nighat Majeed, Iqra Farooq, Zaigham HabibAbstract:BACKGROUND: COVID-19 has caused havoc across the globe since, no specific treatment exists for this disease, thus, far. Hence, there is an urgent need to find an effective treatment to mitigate this scourge. Honey and Nigella sativa are two natural substances with anti-inflammatory, anti-viral, anti-microbial and immune modulating properties. They could be potentially beneficial in these patients. METHODS: We conducted an add-on, randomized, open label, placebo-controlled clinical trial using parallel group design. This was a multi-centered study with superiority framework conducted in RT-PCR confirmed COVID-19 patients showing moderate or severe disease. All patients receiving standard care were randomized into treatment and control groups. In the treatment arm, patients received HNS (honey plus Nigella sativa) in predefined doses for up to 13 days. The primary outcome measures (time taken for alleviation of symptoms, viral clearance and clinical status improvement on day 6) outcomes were assessed. RESULTS: Of 1046 patients testing positive for the SARS-CoV-2, 210 showing moderate and 103 showing severe disease were randomized into treatment and control groups as per inclusion criteria. In the moderate cases, 107 were assigned to the HNS group and 103 to the control group. Among 103 severe cases, 50 were assigned to the HNS group and 53 to the control group. In the moderate and severe cases, the HNS treatment was associated with a normalized median symptoms alleviation time reduction of 3 and 7 days (HR: 6.11; 95% CI: 4.23-8.84 and HR: 4.04; 95% CI, 2.46-6.64) respectively. The HNS treatment in both groups were further associated with 4 days earlier reduction in median viral clearance time (Moderate HR: 5.53; 95% CI: 3.76-8.14) and Severe HR: 4.32; 95% CI: 2.62-7.13). Moreover, in the intention-to-treat analysis, the HNS groups led to a lower (better) clinical score on day 6 with resumption of normal activity among 63.6% of the moderate (OR: 0.07; 95% CI: 0.03-0.13) and 28% of severe cases (OR: 0.03; 95% CI: 0.01-0.09). Furthermore, a significant (14.87%) reduction (OR: 0.18; 95% CI: 0.02-0.92) in mortality was observed in the HNS arm. No difference in adverse effects were seen between the HNS and control arms. CONCLUSIONS: A significant reduction in in the severity of disease, the time taken for viral clearance and mortality was observed with HNS treatment in COVID-19 patients. HNS represents a safe, effective, over the counter and affordable therapy for this pandemic essentially lowering health care burden. It can be used alone or in combination with other expensive treatments and give an additive effect. Hence, the potential of HNS against COVID-19 should be explored in future larger studies. (Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences; NIH Clinical Trial Register number: [NCT04347382][1].) ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04347382 ### Funding Statement Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: IRB Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan approval ID SZH/IRB/0026/2020 and IRB Services Institute of Medical Sciences, Lahore, Pakistan approval ID IRB/2020/658/SIMS All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Clinical data is available as additional file and raw data can be provided on request to corresponding author [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04347382&atom=%2Fmedrxiv%2Fearly%2F2020%2F11%2F03%2F2020.10.30.20217364.atom
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honey and nigella sativa against covid 19 in pakistan hns covid pk a multi center placebo controlled randomized clinical trial
medRxiv, 2020Co-Authors: Sohaib Ashraf, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Iqra Farooq, Zaigham Habib, M H Ashraf, M A Imran, M Akram, Nighat MajeedAbstract:BACKGROUND: No definitive treatment exists for Coronavirus Disease 2019 (COVID-19). Honey and Nigella sativa (HNS) have established antiviral properties. Hence, we investigated the efficacy of HNS against COVID-19. METHODS: We conducted a multicenter, placebo-controlled, randomized clinical trial at 4 centers in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive either honey (1 gm/Kg/day) and Nigella sativa seeds (80 mg/Kg/day) or placebo up-to 13 days along with standard care. The outcomes included symptom alleviation, viral clearance, and 30-day mortality in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT04347382. FINDINGS Three hundred and thirteen patients - 210 moderate and 103 severe - underwent randomization from April 30 to July 29, 2020. Among these, 107 were assigned to HNS whereas 103 to placebo for moderate cases. For severe cases, 50 were given HNS, and 53 were given placebos. HNS resulted in ~50% reduction in time taken to alleviate symptoms as compared to placebo (Moderate (4 versus 7 days), Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, P<0.0001 and severe (6 versus 13 days) HR: 4.04; 95% CI, 2.46-6.64, P<0.0001). HNS also cleared the virus 4 days earlier than the placebo group in moderate (6 versus 10 days, HR: 5.53; 95% CI: 3.76-8.14, P<0.0001) and severe cases (8.5 versus 12 days, HR: 4.32; 95% CI: 2.62-7.13, P<0.0001). HNS further led to a better clinical score on day 6 with normal activity resumption in 63.6% versus 10.9% among moderate cases (OR: 0.07; 95% CI: 0.03-0.13, P<0.0001) and hospital discharge in 50% versus 2.8% in severe cases (OR: 0.03; 95% CI: 0.01-0.09, P<0.0001). In severe cases, mortality rate was four-fold lower in HNS group than placebo (4% versus 18.87%, OR: 0.18; 95% CI: 0.02-0.92, P=0.029). No HNS-related adverse effects were observed. INTERPRETATION HNS significantly improved symptoms, viral clearance, and mortality in COVID-19 patients. Thus, HNS represents an affordable over the counter therapy and can either be used alone or in combination with other treatments to achieve potentiating effects against COVID-19. FUNDING: Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex, and Services Institute of Medical Sciences.
Sohaib Ashraf - One of the best experts on this subject based on the ideXlab platform.
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therapeutic efficacy of honey and nigella sativa against covid 19 a multi center randomized controlled clinical trial hns covid pk
medRxiv, 2020Co-Authors: Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Muhammad Imran, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Nighat Majeed, Iqra Farooq, Zaigham HabibAbstract:BACKGROUND: COVID-19 has caused havoc across the globe since, no specific treatment exists for this disease, thus, far. Hence, there is an urgent need to find an effective treatment to mitigate this scourge. Honey and Nigella sativa are two natural substances with anti-inflammatory, anti-viral, anti-microbial and immune modulating properties. They could be potentially beneficial in these patients. METHODS: We conducted an add-on, randomized, open label, placebo-controlled clinical trial using parallel group design. This was a multi-centered study with superiority framework conducted in RT-PCR confirmed COVID-19 patients showing moderate or severe disease. All patients receiving standard care were randomized into treatment and control groups. In the treatment arm, patients received HNS (honey plus Nigella sativa) in predefined doses for up to 13 days. The primary outcome measures (time taken for alleviation of symptoms, viral clearance and clinical status improvement on day 6) outcomes were assessed. RESULTS: Of 1046 patients testing positive for the SARS-CoV-2, 210 showing moderate and 103 showing severe disease were randomized into treatment and control groups as per inclusion criteria. In the moderate cases, 107 were assigned to the HNS group and 103 to the control group. Among 103 severe cases, 50 were assigned to the HNS group and 53 to the control group. In the moderate and severe cases, the HNS treatment was associated with a normalized median symptoms alleviation time reduction of 3 and 7 days (HR: 6.11; 95% CI: 4.23-8.84 and HR: 4.04; 95% CI, 2.46-6.64) respectively. The HNS treatment in both groups were further associated with 4 days earlier reduction in median viral clearance time (Moderate HR: 5.53; 95% CI: 3.76-8.14) and Severe HR: 4.32; 95% CI: 2.62-7.13). Moreover, in the intention-to-treat analysis, the HNS groups led to a lower (better) clinical score on day 6 with resumption of normal activity among 63.6% of the moderate (OR: 0.07; 95% CI: 0.03-0.13) and 28% of severe cases (OR: 0.03; 95% CI: 0.01-0.09). Furthermore, a significant (14.87%) reduction (OR: 0.18; 95% CI: 0.02-0.92) in mortality was observed in the HNS arm. No difference in adverse effects were seen between the HNS and control arms. CONCLUSIONS: A significant reduction in in the severity of disease, the time taken for viral clearance and mortality was observed with HNS treatment in COVID-19 patients. HNS represents a safe, effective, over the counter and affordable therapy for this pandemic essentially lowering health care burden. It can be used alone or in combination with other expensive treatments and give an additive effect. Hence, the potential of HNS against COVID-19 should be explored in future larger studies. (Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences; NIH Clinical Trial Register number: [NCT04347382][1].) ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04347382 ### Funding Statement Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: IRB Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan approval ID SZH/IRB/0026/2020 and IRB Services Institute of Medical Sciences, Lahore, Pakistan approval ID IRB/2020/658/SIMS All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Clinical data is available as additional file and raw data can be provided on request to corresponding author [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04347382&atom=%2Fmedrxiv%2Fearly%2F2020%2F11%2F03%2F2020.10.30.20217364.atom
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honey and nigella sativa against covid 19 in pakistan hns covid pk a multi center placebo controlled randomized clinical trial
medRxiv, 2020Co-Authors: Sohaib Ashraf, Larab Kalsoom, Uzma Nasim Siddiqui, Muhammad Ghufran, Iqra Farooq, Zaigham Habib, M H Ashraf, M A Imran, M Akram, Nighat MajeedAbstract:BACKGROUND: No definitive treatment exists for Coronavirus Disease 2019 (COVID-19). Honey and Nigella sativa (HNS) have established antiviral properties. Hence, we investigated the efficacy of HNS against COVID-19. METHODS: We conducted a multicenter, placebo-controlled, randomized clinical trial at 4 centers in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive either honey (1 gm/Kg/day) and Nigella sativa seeds (80 mg/Kg/day) or placebo up-to 13 days along with standard care. The outcomes included symptom alleviation, viral clearance, and 30-day mortality in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT04347382. FINDINGS Three hundred and thirteen patients - 210 moderate and 103 severe - underwent randomization from April 30 to July 29, 2020. Among these, 107 were assigned to HNS whereas 103 to placebo for moderate cases. For severe cases, 50 were given HNS, and 53 were given placebos. HNS resulted in ~50% reduction in time taken to alleviate symptoms as compared to placebo (Moderate (4 versus 7 days), Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, P<0.0001 and severe (6 versus 13 days) HR: 4.04; 95% CI, 2.46-6.64, P<0.0001). HNS also cleared the virus 4 days earlier than the placebo group in moderate (6 versus 10 days, HR: 5.53; 95% CI: 3.76-8.14, P<0.0001) and severe cases (8.5 versus 12 days, HR: 4.32; 95% CI: 2.62-7.13, P<0.0001). HNS further led to a better clinical score on day 6 with normal activity resumption in 63.6% versus 10.9% among moderate cases (OR: 0.07; 95% CI: 0.03-0.13, P<0.0001) and hospital discharge in 50% versus 2.8% in severe cases (OR: 0.03; 95% CI: 0.01-0.09, P<0.0001). In severe cases, mortality rate was four-fold lower in HNS group than placebo (4% versus 18.87%, OR: 0.18; 95% CI: 0.02-0.92, P=0.029). No HNS-related adverse effects were observed. INTERPRETATION HNS significantly improved symptoms, viral clearance, and mortality in COVID-19 patients. Thus, HNS represents an affordable over the counter therapy and can either be used alone or in combination with other treatments to achieve potentiating effects against COVID-19. FUNDING: Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex, and Services Institute of Medical Sciences.
