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临床试验/CTRI/2020/11/028809
CTRI/2020/11/028809尚未招募不适用

"EFFICACY OF AYURVEDA TREATMENT PROTOCOL IN THE MANAGEMENT OF PREDIABETES- A RANDOMIZED CONTROLLED CLINICAL TRIAL"

KAHERs Shri BMK AYURVEDA MAHAVIDHYALAYA Pg Studies Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Proposed Ayurveda treatment protocol is effective in prevention of disease progression in prediabetic subjects.

研究概览

简要总结

The study is aimed to Evaluate the efficacy of Ayurveda System protocol  which includes the Intervention drug Triphala Lauha Churna along with Yoga and Diet regimen as described in Ayurveda Classics which was compared with Standard prediabetic care group. No any PG synopsis has been done regarding the topic and drug is also new for the study in diabetes prevention. Thus this holistic approach gives the uniqueness of the study which is expected to prevent disease progression in Pre Diabetic Subjects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Both gender patients attending the OPD & IPD of Shri.BMK Ayurveda Mahavidyalaya, Post Graduate Studies and Research Centre, Shahapur, Belagavi will be screened without bias of social, economic, educational, or religious status.
  • Patients aged between
  • Patients fulfilling the diagnostic criteria of will be included for the study. 4.Patients willing to participate with written consent.

排除标准

  • Cardiovascular and cerebrovascular events (cerebrovascular accident in past 6 months, history of myocardial infarction or heart failure; severe organic heart disease; aneurysm of a main artery or dissecting aneurysm; specific angina; type II degree atrioventricular block; sick sinus syndrome)
  • Endocrine disease, such as hyperthyroidism.
  • Auto allergic disease, cancer or other serious or potentially fatal illness.
  • Pregnancy, preparation for pregnancy or active lactation in women.
  • Patients with mental illness or those who are uncooperative.
  • Refusal to provide consent for the study.

结局指标

主要结局

Proposed Ayurveda treatment protocol is effective in prevention of disease progression in prediabetic subjects.

时间窗: 0, 30days, 60 days, 90days

次要结局

未报告次要终点

研究者

发起方
KAHERs Shri BMK AYURVEDA MAHAVIDHYALAYA Pg Studies Hospital and Research Centre
申办方类型
Private medical college

研究点 (1)

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