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临床试验/CTRI/2024/11/076594
CTRI/2024/11/076594尚未招募3 期

A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF TRIPHALA BHAVITA YAVA SAKTU AND TRIPHALA BHAVITA SYAMAK SAKTU ALONG WITH DIET REGIMN PATHYA AHARA IN THE MANAGEMENT OF DIABETES MELLITUS - A RANDOMIZED CONTROL OPEN LABEL CLINICAL TRIAL

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Significant improvement in Symptoms of Madhumeha

研究概览

简要总结

The study will be carried out to evaluate the the role of Triphala Bhavita syamak saktu in management of Diabetes mellitus. Patients fullfilling the inclusion criteria will be divided into two groups. In control group Triphala
Bhavita yava saktu  will be given in the dose of 10gm BD with Normal
water and in intervention group Triphala
Bhavita syamak saktu  will be given in the dose of  10gm BD with
Normal water along with
holistic approach of Ayurveda (It contains Ayurveda Aushadh, Aahar, Vihar,
Yoga) for 3 months .After 3 months of intervention it will be expected that there will be reduction in HbA1c level, improvement in sign and symptoms of Madhumeha,, reduction in FBS,PPBS,RBS, Improvement in Quality of life in T2DM patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with age group 35-60 years, suffering from Diabetes Mellitus type II.
  • Newly diagnosed case of DM type 2 with FBS 126mg/dl – 220mg/dl and PPS 180mg/dl – 280mg/dl and HbA1c range between 6.5%.
  • Patient willing to participate in the study.

排除标准

  • Patient suffering from Type 1 Diabetes Mellitus and other complications of diabetes such as diabetic neuropathy, Diabetic Retinopathy, Ischemic heart disease.
  • Patient with cardiovascular disease and other systemic Illness.
  • Pregnant women and lactating mother.
  • Patients not willing to participate in the Study.

结局指标

主要结局

Significant improvement in Symptoms of Madhumeha

时间窗: 90 days

次要结局

  • Improvement in Hba1c,FBS,PPBS(90 Days)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ravi kumar

All India Institute of Ayurveda

研究点 (1)

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