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临床试验/CTRI/2018/04/013169
CTRI/2018/04/013169已完成不适用

The Impact of Yoga intervention on physical and mental health of adults with Type 2 Diabetes

Ministry of AYUSH Government of India1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2018年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
152
试验地点
1
主要终点
To assess the effect of yoga intervention in reduction of HbA1c levels.

研究概览

简要总结

Though there are studies which have looked at the impact of yogaintervention on depressive symptoms, stress, cognitive impairment, mindfulnessand quality of life separately, there is no study in India which has looked atthe comprehensive assessment of mental health and the impact of yoga on type 2diabetes.

 We will assess the impact of yoga-pranayama on depression, stress,cognition and various metabolic parameters such as glycemic control,hypertension, and dyslipidemia amongst participants with type 2diabetes in ahospital environment, using subjective and objective measures.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • HbA1c ≥ 7.0 to < 10.5 %.

排除标准

  • Type 1 Diabetes mellitus Patients with a serum creatinine concentration greater than 132.6 mmol/L (1.5 mg/dL) or liver function impairment (AST and ALT 2.5 times upper limit of normal range) Patients have laboratory test abnormality (biochemistry, hematology, or urinalysis) Patients with significant alcohol, drug or medication abuse Currently under a psychiatrist’s care or using antipsychotic or mood stabilizer medication or have diagnosed dementia or bipolar disorder or schizophrenia; Pregnant or lactating Had a documented CVD event (MI, stroke) in past 12 months.

结局指标

主要结局

To assess the effect of yoga intervention in reduction of HbA1c levels.

时间窗: 3 months

次要结局

  • To assess the effect of yoga intervention on mental health parameters(To assess the effect of yoga intervention on blood pressure and lipid profile)

研究者

发起方
Ministry of AYUSH Government of India
申办方类型
Government funding agency

研究点 (1)

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