Pub Date : 2020-12-28DOI: 10.2174/2213476x07999201228111027
A. Abdullah, Rawya Al Kredly, M. Baguneid
Despite the availability of many topical formulations for scar treatment, an objective evaluation of their effect is lacking. To assess the physiological, structural, and mechanical parameters of scar healing by a scar ointment (MEBOScar). 45 patients from the Department of Obstetrics at Al Ain Hospital, UAE, with recently acquired Pfannenstiel scars were recruited into this prospective, open-label, controlled study. Scar ointment was applied to a lateral third of the scar; positive control (silicone gel based topical) to the other lateral third; the middle third was left untreated (negative control). The scars were evaluated at 4 time points up to 12 weeks using non-invasive devices and a scar questionnaire. In comparison with silicone gel, there was a significant reduction in trans epithelial water loss at weeks 2,4,8, and 12 (p<0.001) and scar area at weeks 4, 8 and 12 (p<0.001) with scar ointment. The skin elasticity at week 4 was significantly increased by scar ointment (p=0.007). By week 12, gross colour mismatch of the scar was described by 9% patients with scar ointment (24% with silicone gel, 42% with no treatment; p<0.001). There was significant improvement in scar texture with scar ointment by week 12 (p<0.001). Scar ointment has beneficial effects on objective and subjective patient-reported parameters of Pfannenstiel scars.
{"title":"Efficacy of Topical Formulations in Healing of Caesarean Scars Using NonInvasive Devices: A Controlled Trial","authors":"A. Abdullah, Rawya Al Kredly, M. Baguneid","doi":"10.2174/2213476x07999201228111027","DOIUrl":"https://doi.org/10.2174/2213476x07999201228111027","url":null,"abstract":"\u0000\u0000 Despite the availability of many topical formulations for scar treatment, an objective evaluation of\u0000their effect is lacking.\u0000\u0000\u0000\u0000To assess the physiological, structural, and mechanical parameters of scar healing by a scar ointment (MEBOScar).\u0000\u0000\u0000\u0000\u000045 patients from the Department of Obstetrics at Al Ain Hospital, UAE, with recently acquired Pfannenstiel scars\u0000were recruited into this prospective, open-label, controlled study. Scar ointment was applied to a lateral third of the scar;\u0000positive control (silicone gel based topical) to the other lateral third; the middle third was left untreated (negative control).\u0000The scars were evaluated at 4 time points up to 12 weeks using non-invasive devices and a scar questionnaire.\u0000\u0000\u0000\u0000 In comparison with silicone gel, there was a significant reduction in trans epithelial water loss at weeks 2,4,8, and\u000012 (p<0.001) and scar area at weeks 4, 8 and 12 (p<0.001) with scar ointment. The skin elasticity at week 4 was significantly\u0000increased by scar ointment (p=0.007). By week 12, gross colour mismatch of the scar was described by 9% patients with\u0000scar ointment (24% with silicone gel, 42% with no treatment; p<0.001). There was significant improvement in scar texture\u0000with scar ointment by week 12 (p<0.001).\u0000\u0000\u0000\u0000 Scar ointment has beneficial effects on objective and subjective patient-reported parameters of Pfannenstiel\u0000scars.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78451213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bovine Trypanosomosis is one of the most parsimoniously challenging diseases in influencing mammals like cattle and it is a grave haemoprotozoan disease triggered by different species of unicellular eukaryotic parasite of the genus trypanosome. This study was conducted to assess the prevalence of bovine trypanosomosis, and the influence of associated risk factors on cattle reared in Chora district of Buno Bedele Zone. A Blood sample was collected from a total of 401 cattle of age ranges from 1 to 6 years. The presence of parasites from sampled blood was examined using a method of Buffy Coat Technique and a technique of Giemsa-stained thin blood films was used to identify the existing trypanosome species in the study area. The Packed Cell Volume (PCV) of collected blood samples was determined using haematocrit. A total of 50 traps were deployed to study the entomological survey. In general, 2.99 % of the studied cattle were infected with Trypanosomosis and the T.Vivax (58.33%) was the dominant species of trypanosomosis and followed by T. congulense (41.67%) in the study area. Statistically significant differences (P<0.05) were observed due to associated risk factors viz. Body Condition and age of cattle, whereas sampling sites and sex did not significantly affect the prevalence of Bovine Trypanosomosis. The mean PCV value of Parasitaemic and Aparasitaemic animals were 21.37 ± 0.19 and 27.89 ± 0.16, respectively and they were statistically different at (P< 0.05). Overall of 0.80 flies per trap per day was recorded from the study area and among the caught flies of Glossina species, 10%, 54% and 36% of them were, G.tachinoides, G.pallidipes and G.fuscipes, respectively. Therefore, the veterinarian’s has to continue providing the appropriate medication/treatment for the infected animals per appropriate recommendation and Bedele NTTICC has to take more focus to control the density and distribution of tsetse flies as well as biting flies for the transmission of high incidence of T. Vivax through mechanical ways of transmission of the disease.
{"title":"Study on Bovine Trypanosomosis and Associated Risk Factors in Chora District of Oromia Region, Ethiopia","authors":"Alemitu Adisu","doi":"10.31579/2693-4779/016","DOIUrl":"https://doi.org/10.31579/2693-4779/016","url":null,"abstract":"Bovine Trypanosomosis is one of the most parsimoniously challenging diseases in influencing mammals like cattle and it is a grave haemoprotozoan disease triggered by different species of unicellular eukaryotic parasite of the genus trypanosome. This study was conducted to assess the prevalence of bovine trypanosomosis, and the influence of associated risk factors on cattle reared in Chora district of Buno Bedele Zone. A Blood sample was collected from a total of 401 cattle of age ranges from 1 to 6 years. The presence of parasites from sampled blood was examined using a method of Buffy Coat Technique and a technique of Giemsa-stained thin blood films was used to identify the existing trypanosome species in the study area. The Packed Cell Volume (PCV) of collected blood samples was determined using haematocrit. A total of 50 traps were deployed to study the entomological survey. In general, 2.99 % of the studied cattle were infected with Trypanosomosis and the T.Vivax (58.33%) was the dominant species of trypanosomosis and followed by T. congulense (41.67%) in the study area. Statistically significant differences (P<0.05) were observed due to associated risk factors viz. Body Condition and age of cattle, whereas sampling sites and sex did not significantly affect the prevalence of Bovine Trypanosomosis. The mean PCV value of Parasitaemic and Aparasitaemic animals were 21.37 ± 0.19 and 27.89 ± 0.16, respectively and they were statistically different at (P< 0.05). Overall of 0.80 flies per trap per day was recorded from the study area and among the caught flies of Glossina species, 10%, 54% and 36% of them were, G.tachinoides, G.pallidipes and G.fuscipes, respectively. Therefore, the veterinarian’s has to continue providing the appropriate medication/treatment for the infected animals per appropriate recommendation and Bedele NTTICC has to take more focus to control the density and distribution of tsetse flies as well as biting flies for the transmission of high incidence of T. Vivax through mechanical ways of transmission of the disease.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91257858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pressure ulcer or pressure sore is one of the complications seen in bedridden patients. Management of these ulcers is often challenging. But there is no well-established method that accelerates the wound healing rate. Various adjunctive methods are used for wound bed preparation before definitive reconstruction plan is made. Here we describe our experience in the role of insulin therapy as an adjunct in the management of pressure sores.
{"title":"Role of topical insulin therapy as an adjunct in the management of pressure ulcer","authors":"R. Chittoria","doi":"10.31579/2578-8868/15","DOIUrl":"https://doi.org/10.31579/2578-8868/15","url":null,"abstract":"Pressure ulcer or pressure sore is one of the complications seen in bedridden patients. Management of these ulcers is often challenging. But there is no well-established method that accelerates the wound healing rate. Various adjunctive methods are used for wound bed preparation before definitive reconstruction plan is made. Here we describe our experience in the role of insulin therapy as an adjunct in the management of pressure sores.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84254429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Epidemiology in its modern form is a relatively new discipline and uses quantitative methods to study diseases in human populations to inform prevention and control efforts [7]. Causation is an essential concept in epidemiology (Figure 1) [7] yet there is no single, clearly articulated definition for the discipline. Causal inference may be viewed as a special case of the more general process of scientific reasoning, about which there is substantial scholarly debate among scientists and philosophers.
{"title":"The Concept of Causation and some common Epidemiological study Designs","authors":"Manvi Gupta","doi":"10.31579/2693-4779/019","DOIUrl":"https://doi.org/10.31579/2693-4779/019","url":null,"abstract":"Epidemiology in its modern form is a relatively new discipline and uses quantitative methods to study diseases in human populations to inform prevention and control efforts [7]. Causation is an essential concept in epidemiology (Figure 1) [7] yet there is no single, clearly articulated definition for the discipline. Causal inference may be viewed as a special case of the more general process of scientific reasoning, about which there is substantial scholarly debate among scientists and philosophers.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89478104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Various modalities of treatment options and dressing materials are available in today’s era of medical advancement. A lot of newer dressing materials and adjuncts are in use for burn wound management. Bilaminar dermal regeneration template has been in use since the 1980s but owing to its high cost, its affordability and availability in third world developing countries is questionable. Here we have described our experience with the use of an indigenously made cost effective dermal regeneration template made from available materials in degloving injury raw area.
{"title":"Role of indigenous Bilaminar dermal regeneration template in the management of degloving injury","authors":"R. Chittoria","doi":"10.31579/2693-4779/017","DOIUrl":"https://doi.org/10.31579/2693-4779/017","url":null,"abstract":"Various modalities of treatment options and dressing materials are available in today’s era of medical advancement. A lot of newer dressing materials and adjuncts are in use for burn wound management. Bilaminar dermal regeneration template has been in use since the 1980s but owing to its high cost, its affordability and availability in third world developing countries is questionable. Here we have described our experience with the use of an indigenously made cost effective dermal regeneration template made from available materials in degloving injury raw area.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90372852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pressure ulcer or pressure sore is one of the complications seen in bedridden patients. Management of these ulcers is often challenging. But there is no well-established method that accelerates the wound healing rate. Various adjunctive methods are used for wound bed preparation before definitive reconstruction plan is made. Here we describe our experience in the role of insulin therapy as an adjunct in the management of pressure sores.
{"title":"Role of topical insulin therapy as an adjunct in the management of pressure ulcer","authors":"Shucheng Gang","doi":"10.31579/2693-4779/015","DOIUrl":"https://doi.org/10.31579/2693-4779/015","url":null,"abstract":"Pressure ulcer or pressure sore is one of the complications seen in bedridden patients. Management of these ulcers is often challenging. But there is no well-established method that accelerates the wound healing rate. Various adjunctive methods are used for wound bed preparation before definitive reconstruction plan is made. Here we describe our experience in the role of insulin therapy as an adjunct in the management of pressure sores.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79151526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Since the outbreak of the COVID-19 virus in Wuhan, China, in early 2020, the Chinese government has formed a mode of information disclosure. More than 400 cities have announced specific location information for newly diagnosed cases of novel coronavirus pneumonia, including residential areas or places of stay. We have established a conditional random field model and a rule-dependent model based on Chinese geographical name elements. Taking Guangdong Province as an example, the identification of named entities and the automatic extraction of epidemic-related sites are carried out. This method will help locate the spread of the epidemic, prevent and control the spread of the epidemic, and gain more time for vaccine clinical trials. Methods: Based on the presentation form of the habitual place or place of stay of the diagnosed cases in the text of the web page, a conditional random field model is established, and a rule-dependent model is established according to the combination rule of the elements of the place words and the place name dictionary composed of provinces, cities and administrative regions. Findings: The results of the analysis based on the conditional random field model and the rule-dependent model show that the location of confirmed cases of new coronavirus pneumonia in Guangdong Province in mid-February is mainly concentrated in Guangzhou，Shenzhen，Zhuhai and Shantou Cities. In Guangzhou, Futian District has more epidemicsites and Huangpu and Conghua District have fewer epidemic sites. Government officials in Guangzhou City should pay attention to Futian District. Interpretation: Governments at all levels in Guangzhou Province have intervened to control the epidemic through various means in mid-February. According to the results of the model analysis, we believe that the administrative regions with more diagnosed locations should focus on and take measures such as blockades and control of personnel flow to control the disease in those administrative regions to avoid affecting other adjacent administrative regions.
{"title":"Epidemic-related sites in covid-19 media reports","authors":"Bin Zhao","doi":"10.31579/2693-4779/005","DOIUrl":"https://doi.org/10.31579/2693-4779/005","url":null,"abstract":"Background: Since the outbreak of the COVID-19 virus in Wuhan, China, in early 2020, the Chinese government has formed a mode of information disclosure. More than 400 cities have announced specific location information for newly diagnosed cases of novel coronavirus pneumonia, including residential areas or places of stay. We have established a conditional random field model and a rule-dependent model based on Chinese geographical name elements. Taking Guangdong Province as an example, the identification of named entities and the automatic extraction of epidemic-related sites are carried out. This method will help locate the spread of the epidemic, prevent and control the spread of the epidemic, and gain more time for vaccine clinical trials. Methods: Based on the presentation form of the habitual place or place of stay of the diagnosed cases in the text of the web page, a conditional random field model is established, and a rule-dependent model is established according to the combination rule of the elements of the place words and the place name dictionary composed of provinces, cities and administrative regions. Findings: The results of the analysis based on the conditional random field model and the rule-dependent model show that the location of confirmed cases of new coronavirus pneumonia in Guangdong Province in mid-February is mainly concentrated in Guangzhou，Shenzhen，Zhuhai and Shantou Cities. In Guangzhou, Futian District has more epidemicsites and Huangpu and Conghua District have fewer epidemic sites. Government officials in Guangzhou City should pay attention to Futian District. Interpretation: Governments at all levels in Guangzhou Province have intervened to control the epidemic through various means in mid-February. According to the results of the model analysis, we believe that the administrative regions with more diagnosed locations should focus on and take measures such as blockades and control of personnel flow to control the disease in those administrative regions to avoid affecting other adjacent administrative regions.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88432454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Over the period, due to evolutionary constrains, gene mutations, changes in micro- and mega- environment gave a tool to bacteria to adopt for survival in the hostile environment. When they are exposed with broad spectrum antibiotics, they have adopted to live and become resistant to antibiotics. In this review many preventive and curative strategies has been described to avoid antibiotics. These lines of treatments would not give chances to microbes to become drug resistant. “Prevention is better than cure” adopting this strategy we have described immunochemicals and many herbal medicines which will prevent infections. Also given importance to maintain proper balance of microbiota in the gut by replacement of the lost (may be due to many reasons) species which are considered necessary for maintaining a balance in bacterial population.
{"title":"Reducing drug resistance should be the aim of therapies","authors":"P. D. Gupta","doi":"10.46940/ijpi.01.1003","DOIUrl":"https://doi.org/10.46940/ijpi.01.1003","url":null,"abstract":"Over the period, due to evolutionary constrains, gene mutations, changes in micro- and mega- environment gave a tool to bacteria to adopt for survival in the hostile environment. When they are exposed with broad spectrum antibiotics, they have adopted to live and become resistant to antibiotics. In this review many preventive and curative strategies has been described to avoid antibiotics. These lines of treatments would not give chances to microbes to become drug resistant. “Prevention is better than cure” adopting this strategy we have described immunochemicals and many herbal medicines which will prevent infections. Also given importance to maintain proper balance of microbiota in the gut by replacement of the lost (may be due to many reasons) species which are considered necessary for maintaining a balance in bacterial population.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73712565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-08-27DOI: 10.2174/2213476x07666200827102951
Sankha Bhattacharya
Poor aqueous solubility, oral bioavailability, inter, and inter-subject variability, and physical stability have always been a concern for pharmaceutical formulation scientists while formulating an oral dosage form. Self-Emulsifying Drug Delivery System (SEDDS) is a promising new approach to mitigating those potential problems. The main advantages of SEDDS are that it increases the solubility and decreases the bio-degradation of lipophilic drugs. Mostly BCS II & IV Class drugs are preferable. SEDDS is an admixture of drugs, oil, surfactants, cosolvents, and stabilizers. With little energy input, they form (o/w) microemulsion within the G.I. lumen. The present review discusses the various formulations of SEDDS, selection criteria for surfactants, oils, Patentable SEDDS dosage forms, solidification technique, characterization, and future approaches.
{"title":"Self-Emulsifying Drug Delivery System (SEDDS) and its Pharmaceutical Applications","authors":"Sankha Bhattacharya","doi":"10.2174/2213476x07666200827102951","DOIUrl":"https://doi.org/10.2174/2213476x07666200827102951","url":null,"abstract":"\u0000\u0000Poor aqueous solubility, oral bioavailability, inter, and inter-subject\u0000variability, and physical stability have always been a concern for pharmaceutical\u0000formulation scientists while formulating an oral dosage form. Self-Emulsifying\u0000Drug Delivery System (SEDDS) is a promising new approach to mitigating those\u0000potential problems. The main advantages of SEDDS are that it increases the solubility\u0000and decreases the bio-degradation of lipophilic drugs. Mostly BCS II & IV\u0000Class drugs are preferable. SEDDS is an admixture of drugs, oil, surfactants, cosolvents,\u0000and stabilizers. With little energy input, they form (o/w) microemulsion\u0000within the G.I. lumen. The present review discusses the various formulations of\u0000SEDDS, selection criteria for surfactants, oils, Patentable SEDDS dosage forms,\u0000solidification technique, characterization, and future approaches.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91295629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-08-25DOI: 10.2174/2213476x07666200825193259
P. Dande, Purva Samant, Yashita Y. Singh, Umang Sheth
The nutraceutical industry has three main segments, including herbal/- natural products, dietary supplements and functional foods. The dietary supplements market is preliminarily driven by the paradigm shift towards preventive health management practices, amid rising healthcare costs and increasing burden of lifestyle diseases. Rise in healthcare expenditure, increased usage of nutraceuticals product as a substitute to prescription and OTC drugs and augmented demand for the nutritional diet are the major factors driving the global nutraceuticals market. Many individual laws were devised to govern its manufacturing and sale. However, increasing regulatory formalities from multiple agencies and laws, complicate the development, testing and marketing of these substances and hamper the growth of the nutraceutical market. Globally, the regulatory authorities are aware of the changing needs of consumers and proactively protect consumers by amending existing laws to accommodate changes. Market entry requirements of nutraceuticals, functional foods and supplements vary from country to country. The global regulatory guidelines aim at regulating various aspects of the nutraceutical and dietary supplements market, focusing on its manufacture, testing, labeling, sale and registration to assure safety and quality of the product. The major change that was introduced was the ban on marketing Nutraceuticals as medicinal products. This review has been performed to provide a comprehensive understanding of the global regulatory requirements with critical analysis of the Indian regulatory guidelines to explore the lacunae and suggest the need of further amendments in the form of recommendations that can be incorporated into regulatory body guidelines to make it more competitive for national & international trade.
{"title":"Safety and Quality of Nutraceuticals: Have FSSAI Guidelines been Able to Blaze the Trail?","authors":"P. Dande, Purva Samant, Yashita Y. Singh, Umang Sheth","doi":"10.2174/2213476x07666200825193259","DOIUrl":"https://doi.org/10.2174/2213476x07666200825193259","url":null,"abstract":"\u0000\u0000The nutraceutical industry has three main segments, including herbal/-\u0000natural products, dietary supplements and functional foods. The dietary supplements\u0000market is preliminarily driven by the paradigm shift towards preventive\u0000health management practices, amid rising healthcare costs and increasing burden\u0000of lifestyle diseases. Rise in healthcare expenditure, increased usage of nutraceuticals\u0000product as a substitute to prescription and OTC drugs and augmented demand\u0000for the nutritional diet are the major factors driving the global nutraceuticals\u0000market. Many individual laws were devised to govern its manufacturing and\u0000sale. However, increasing regulatory formalities from multiple agencies and\u0000laws, complicate the development, testing and marketing of these substances and\u0000hamper the growth of the nutraceutical market. Globally, the regulatory authorities\u0000are aware of the changing needs of consumers and proactively protect consumers\u0000by amending existing laws to accommodate changes. Market entry requirements\u0000of nutraceuticals, functional foods and supplements vary from country\u0000to country. The global regulatory guidelines aim at regulating various aspects\u0000of the nutraceutical and dietary supplements market, focusing on its manufacture,\u0000testing, labeling, sale and registration to assure safety and quality of the\u0000product. The major change that was introduced was the ban on marketing Nutraceuticals\u0000as medicinal products. This review has been performed to provide a\u0000comprehensive understanding of the global regulatory requirements with critical\u0000analysis of the Indian regulatory guidelines to explore the lacunae and suggest\u0000the need of further amendments in the form of recommendations that can be incorporated\u0000into regulatory body guidelines to make it more competitive for national\u0000& international trade.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73186242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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