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临床试验/CTRI/2024/05/066621
CTRI/2024/05/066621尚未招募2/3 期

An open labeled randomized clinical trial to assess the efficacy of Rasapachaka Kashaya on overweight Prediabetic persons w.s.r. to Sthaulya.

Government Ayurvedic College and Hospital Nanded1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
118
试验地点
1
主要终点
Changes in the insulin resistance (HOMA-IR) value to be calculated with fasting glucose(mg/dl) ,fasting insulin levels(mu/L) and the HbA1c(%) values.

研究概览

简要总结

This is an open labeled randomized clinical trial on overweight prediabetic persons. 

The prevalence of Diabetes Mellitus and its harbinger, Impaired Glucose Tolerance (Prediabetes) is highest in India and United States. The disease is associated with early and ongoing secondary pathophysiologic changes contributing to conditions like Cardiovascular Disease.

It is also associated with complications like End Stage Renal Disease, Non traumatic lower extrimity amputation, Adult blindness etc.

Ayurveda provides holistic approach in diagnosing and treating diseases. Previous study was conducted on combination of Rukshan Dravya Churna (Triphala, Musta, Chitraka) which showed results on Insulin Resistance in Obese students. Rasapachaka Kashaya is mentioned for treatment of Visham Jwara in Charaka Chikitsa. It contains Indrayava, Patol and Kutaki and thus exhibit actions like Agnideepan, Amapachana, Strotoshodhana, Mala-apahar, Rechana and Bhedan according to Ayurveda. So they are advised for treating diseases like Jwara, Ama, Hridroga, Prameha etc. Thus, Rasapachaka Kashaya can counteract the pathology of the disease and re- establish proper metabolism in overweight Prediabetic persons.

So the drug has been chosen as trail drug in the dose of 40 ml bid and Rukshaniya Dravya Churna as control drug in the dose of 9 g with leukwarm water for a period of 90 days in overweight prediabetic persons.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Patients with FPG:100-125mg/dL and HbA1c: 5.7-6.4% without any medication.
  • Age group 30-60 yrs.
  • Patients will be selected irrespective of their sex, religion, geographical areas and economical condition.

排除标准

  • Patients with history of other diseases leading to DM (Autoimmune, Secondary to other diseases or condition).
  • 2.Pregnant and lactating women.
  • 3.Other major systemic disorders with complication.
  • Patients on steroidal intake for any other major systemic diseases.

结局指标

主要结局

Changes in the insulin resistance (HOMA-IR) value to be calculated with fasting glucose(mg/dl) ,fasting insulin levels(mu/L) and the HbA1c(%) values.

时间窗: 0 and 91st days for objective criterias.

次要结局

  • 1. To assess effect of Rasapachaka Kashaya on Fasting Plasma Glucose, HbA1c.(2. To assess the effect of Rasapachaka Kashaya on Insulin Resistance (Calculated with HOMA IR))

研究者

发起方
Government Ayurvedic College and Hospital Nanded
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Snehal Sukhadeo Bhele

Govt. Ayurved College, Nanded

研究点 (1)

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