跳至主要内容
临床试验/CTRI/2024/07/069968
CTRI/2024/07/069968尚未招募Phase 3 4

A Randomised Comparative Clinical Study To Evaluate the Efficacy of Virechana in Sthula Pramehi (Obese NIDDM) with and without Udwarthana as Purvakarma wsr to assess the Rukshana effect

Dr Suma KJ1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Reduction in signs & symptoms of Diabetes and obesity.

研究概览

简要总结

The burden of Diabetes is high and increasing globally, and in developing economies like India, mainly fueled by the increasing prevalence of Overweight/Obesity and Unhealthy Lifestyles. The estimates in 2019 showed that 77 million individuals had Diabetes in India, which is expected to rise to over 134 million by 2045.

Prameha is a Tri doshaja Vyadhi, mainly with vitiation of Kapha, Meda and Shareera Kleda and Madhumeha (Vataja Prameha) renders the condition more dreadful with association of Vata. Acharyas Charaka and Sushrutha have mentioned Shodhana as the line of treatment for Sthula Pramehi where as Vagbhata has mentioned Vamana and Virechana are the prime treatment in Prameha as it does Kleda shamana. The treatment of Prameha is served by the dual approach of Shodhana and Brimhana in Sthula and Krisha patients respectively.

In this study, Udwarthana has been taken as a Purvakarma before Virechana. According to Acharya Vaghbhata patients who are – Mamsala, Medhura, Bhuri Shleshma, Vishamagni, has to undergo Rukshana as Purvakarma before Snehana. As Prameha is associated with Kapha and Medha dhatu, here also in Sthula Pramehi Udwarthana is selected for Purvakarma in one group.

Group A- receives Udwarthana (Triphala, Kolakulatthadi churna) and Bashpa Sweda as a Purvakarma for 7 days, Shodhananga Snehapana with Priyangwadi Ghrita followed by Virechana.

Group B- (No Udwarthana) receives Deepana Pachana with T. Chitrakadi vati 2bd before food for 3 days (or till nirama lakshanas are seen). Shodhananga Snehapana with Priyangwadi Ghrita till Samyak Snigdha Lakshanas. During Vishrama kala - Sarvanga Abhyanga with Moorchita Tila Taila and Mrudu Bashpasweda will be given for 3days.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 New and old cases of Prameha (patients on OHAs also will be taken but not on Insulin) 2 Patients fit for Snehapana 3Patients fit for Virechana karma 4 Patients with Prameha having BMI 25 to 35 kg/m2 (Overweight and Obese) 5 Patients with blood sugar levels FBS more than 126 mg/dl, PPBS more than 180 mg/dl and HbA1c more than 6.

排除标准

  • 1 Patients with Juvenile Diabetes, IDDM and any other complications or systemic diseases which interfere in the course of treatment.
  • 2 Pregnant woman.

结局指标

主要结局

Reduction in signs & symptoms of Diabetes and obesity.

时间窗: day 0,7,14, 90

1. FBS

时间窗: day 0,7,14, 90

2. PPBS

时间窗: day 0,7,14, 90

3. HbA1c

时间窗: day 0,7,14, 90

4. BMI

时间窗: day 0,7,14, 90

5. Hip waist ratio

时间窗: day 0,7,14, 90

6. S. Lipid Profile

时间窗: day 0,7,14, 90

次要结局

  • FBS, PPBS, HbA1c (Before treatment and after 3 months), Urine sugar(Mutra pareeksha before, after Rukshana and after Virechana (Avila Mutrata – Turbidity) by Spectrophotometer (at Indukaka Ipcowala College of Pharmacy))

研究者

发起方
Dr Suma KJ
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Suma K J

G. J. Patel Institute of Ayurvedic Studies and Research

研究点 (1)

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