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临床试验/CTRI/2019/04/018494
CTRI/2019/04/018494招募中不适用

A Field Study on Ayurvedic Management of Type 2 Diabetes Mellitus

Jivanti Welfare and Charitable Trust4 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2019年10月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
6,000
试验地点
4
主要终点
FBS, HbA1C

研究概览

简要总结

Diabetes has been on the rise in India. There is now more than ever, a need to have a comprehensive cost-effective mass health care strategy to address the disease and its associated complication. Apart from the management of Diabetes, it also becomes vital to screen and identify the high-risk population and put in place appropriate interventions / strategies to prevent progression to diabetes mellitus.

VYASA is a yoga research foundation established in 1986 for education, research and propagation of all applications of Yoga with a vision to make Yoga a socially relevant science.

S-VYASA (a deemed University under section 3 of UGC act 1956), a NAAC A+ accredited University established in 2002 is an off shoot of VYASA.As a part of its mission, VYASA has scientifically validated Yoga practices and has been able to scientifically develop and administer personalised disease specific Yoga modules. In 2016, an initiative of VYASA was funded by the Ministry of AYUSH and conducted by IYA (Indian Yoga Association) as a nationwide randomised controlled research study of implementing Yoga based life style change program – Niyantritha Madhumeha Bharatha [NMB] to treat and prevent incidence of Type 2 Diabetes mellitus.

Under the national scheme NMB, 2,40,968 adults were screened for Diabetes mellitus across the country in both urban and rural areas of India. Under the same scheme those diagnosed Type 2 Diabetes mellitus patients and those with high-risk were treated with Yoga and followed up for 3 months to understand the efficacy of Yoga.

In the present study we propose to study the efficacy of action of AYUSH-82 extract tablet in management of Type 2 Diabetes mellitus patients. Standardized ayurvedic formulation, AYUSH-82 extract tablet will be administered as intervention. The study is funded under the CSR (Corporate Social Responsibility) program of Jivanti Welfare and Charitable Trust (JWCT).

研究设计

研究类型
Interventional

入排标准

年龄范围
25.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • With or Without hypertension and obesity With or Without Oral Hypo-glycaemic drugs [Any OHA] HbA1c >5.8%.

排除标准

  • 1.Type 2 Diabetes mellitus patients with major or minor cardiac, ophthalmic, renal complications.
  • 2.Type 2 Diabetes mellitus patients with major neurological complications.
  • 3.Type 2 Diabetes mellitus patients with associated conditions such as uncontrolled hypertension (persistent BP > 180/ 100 mm of Hg after two consecutive recordings and also by checking from their earlier medical records).
  • 4.Type 2 Diabetes mellitus patients with severe obesity [BMI ≥ 40 kg/m2].
  • 6.Type 2 Diabetes mellitus patients with history of tuberculosis within past 3 years.
  • 7.Type 2 Diabetes mellitus patients with History of head injury, or psychiatric disorder in the past 8.Type 2 Diabetes mellitus patients in Pregnancy and lactation.
  • 9.Type 2 Diabetes mellitus patients who are taking Homeopathy, Ayurveda, Unani & Siddha systems of medicine.

结局指标

主要结局

FBS, HbA1C

时间窗: 0,3,6,12 Months

次要结局

  • Liver function test, Kidney Function Test, Lipid Profile(0,12 Months)

研究者

发起方
Jivanti Welfare and Charitable Trust
申办方类型
Other [trust]

研究点 (4)

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