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

IF 1.7 Q2 Medicine Advances in integrative medicine Pub Date : 2022-03-01 DOI:10.1016/j.aimed.2021.07.002
Prashanth Shetty , Shivaprasad Shetty , H.C. Shashikiran , T. Rajany
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引用次数: 1

摘要

背景2型糖尿病(T2DM)是一种主要的生活方式障碍,伴有多种全身并发症。生活方式的改变和慢性精神压力的管理在治疗和预防T2DM中起着重要作用。自然疗法使用改变生活方式和自然疗法来治疗疾病。瑜伽练习在压力管理方面的有效性已被各种研究证明。在这项研究中,我们评估了自然疗法和瑜伽生活方式干预对2型糖尿病患者人体测量、生化、电生理参数和心血管风险发展的影响。方法采用前瞻性随机平行组试验。研究分为两个阶段:强化阶段和继续阶段。252例T2DM患者经筛查后随机分为干预组和对照组。干预组将接受高强度的N&Y干预,并有严格的治疗方案和饮食方案,而对照组不接受任何干预。两组的数据将在第1天和第11天收集,之后将对参与者进行为期9个月的前瞻性随访,每三个月进行一次间歇性评估,即第1天、第11天、第90天、第180天、第270天。根据协议,我们开始招募受试者,他们的数据被成功收集到第90天,并且正在系统地进行下一次评估的后续工作。结论在强化阶段,患者将学习一种可以治疗或控制T2DM的生活方式,前瞻性随访将鼓励患者保持这种生活方式。因此,我们认为综合的N&Y方法在治疗和预防2型糖尿病并发症方面具有更有效和持久的效果。该研究有足够的潜力为N&Y干预T2DM及相关危险因素的有效性提供科学证据。临床试验注册号;CTRI / 2018/12/016550
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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.

Clinical trial registration number; CTRI/2018/12/016550

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来源期刊
Advances in integrative medicine
Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
3.20
自引率
11.80%
发文量
0
审稿时长
15 weeks
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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