{"title":"自然疗法和瑜伽为基础的生活方式干预2型糖尿病-随机平行组试验的研究方案","authors":"Prashanth Shetty , Shivaprasad Shetty , H.C. Shashikiran , T. Rajany","doi":"10.1016/j.aimed.2021.07.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Type 2 Diabetes Mellitus<span> (T2DM) is one of major life style disorder with multiple systemic complications. Lifestyle modification and management of chronic mental stress plays a major role in treating and preventing T2DM. Naturopathy uses lifestyle modification and natural therapies to cure the diseases. Effectiveness of Yoga practice in stress management<span> is proven through various studies. In this study we evaluate the effect of Naturopathy and Yogic lifestyle intervention on the anthropometric, biochemical, electrophysiological parameters and development of cardiovascular risk among T2DM patients.</span></span></p></div><div><h3>Methods</h3><p>The study is a prospective randomized parallel group trial. The study is divided into two phases, intensive phase and continuation phase. 252 T2DM patients will be randomized into intervention group and control group after screening. The intervention group will receive intense N&Y intervention with a strict treatment protocol and diet regimen, whereas the control group will not receive any intervention. Data for both groups will be collected on day 1 and day 11, after which participants will be followed prospectively for nine months with intermittent assessments scheduled once in every three months that is, day 1, day 11, day 90, day 180, day 270. As per the protocol we started recruiting the subjects and their data were collected successfully till day 90 and the follow up for the next assessments is being done systematically.</p></div><div><h3>Conclusion</h3><p>During the intensive phase, patient will be learning a lifestyle regimen which can treat or control T2DM and the prospective follow up will encourage in maintaining it. Hence, we believe that integrated N&Y approach will give more effective and lasting effects in treating and preventing complications of T2DM. The study is potential enough to give scientific evidence on effectiveness of N&Y intervention on T2DM and associated risk factors.</p><p>Clinical trial registration number; CTRI/2018/12/016550</p></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.aimed.2021.07.002","citationCount":"1","resultStr":"{\"title\":\"Naturopathy and yoga based lifestyle intervention for type 2 diabetes mellitus – Study protocol for a randomized parallel group trial\",\"authors\":\"Prashanth Shetty , Shivaprasad Shetty , H.C. Shashikiran , T. Rajany\",\"doi\":\"10.1016/j.aimed.2021.07.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Type 2 Diabetes Mellitus<span> (T2DM) is one of major life style disorder with multiple systemic complications. Lifestyle modification and management of chronic mental stress plays a major role in treating and preventing T2DM. Naturopathy uses lifestyle modification and natural therapies to cure the diseases. Effectiveness of Yoga practice in stress management<span> is proven through various studies. In this study we evaluate the effect of Naturopathy and Yogic lifestyle intervention on the anthropometric, biochemical, electrophysiological parameters and development of cardiovascular risk among T2DM patients.</span></span></p></div><div><h3>Methods</h3><p>The study is a prospective randomized parallel group trial. The study is divided into two phases, intensive phase and continuation phase. 252 T2DM patients will be randomized into intervention group and control group after screening. The intervention group will receive intense N&Y intervention with a strict treatment protocol and diet regimen, whereas the control group will not receive any intervention. Data for both groups will be collected on day 1 and day 11, after which participants will be followed prospectively for nine months with intermittent assessments scheduled once in every three months that is, day 1, day 11, day 90, day 180, day 270. As per the protocol we started recruiting the subjects and their data were collected successfully till day 90 and the follow up for the next assessments is being done systematically.</p></div><div><h3>Conclusion</h3><p>During the intensive phase, patient will be learning a lifestyle regimen which can treat or control T2DM and the prospective follow up will encourage in maintaining it. Hence, we believe that integrated N&Y approach will give more effective and lasting effects in treating and preventing complications of T2DM. The study is potential enough to give scientific evidence on effectiveness of N&Y intervention on T2DM and associated risk factors.</p><p>Clinical trial registration number; CTRI/2018/12/016550</p></div>\",\"PeriodicalId\":7343,\"journal\":{\"name\":\"Advances in integrative medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2022-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/j.aimed.2021.07.002\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in integrative medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2212958821000537\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958821000537","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Naturopathy and yoga based lifestyle intervention for type 2 diabetes mellitus – Study protocol for a randomized parallel group trial
Background
Type 2 Diabetes Mellitus (T2DM) is one of major life style disorder with multiple systemic complications. Lifestyle modification and management of chronic mental stress plays a major role in treating and preventing T2DM. Naturopathy uses lifestyle modification and natural therapies to cure the diseases. Effectiveness of Yoga practice in stress management is proven through various studies. In this study we evaluate the effect of Naturopathy and Yogic lifestyle intervention on the anthropometric, biochemical, electrophysiological parameters and development of cardiovascular risk among T2DM patients.
Methods
The study is a prospective randomized parallel group trial. The study is divided into two phases, intensive phase and continuation phase. 252 T2DM patients will be randomized into intervention group and control group after screening. The intervention group will receive intense N&Y intervention with a strict treatment protocol and diet regimen, whereas the control group will not receive any intervention. Data for both groups will be collected on day 1 and day 11, after which participants will be followed prospectively for nine months with intermittent assessments scheduled once in every three months that is, day 1, day 11, day 90, day 180, day 270. As per the protocol we started recruiting the subjects and their data were collected successfully till day 90 and the follow up for the next assessments is being done systematically.
Conclusion
During the intensive phase, patient will be learning a lifestyle regimen which can treat or control T2DM and the prospective follow up will encourage in maintaining it. Hence, we believe that integrated N&Y approach will give more effective and lasting effects in treating and preventing complications of T2DM. The study is potential enough to give scientific evidence on effectiveness of N&Y intervention on T2DM and associated risk factors.
期刊介绍：
Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.
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