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临床试验/CTRI/2024/10/075867
CTRI/2024/10/075867招募中Phase 3 4

Evaluation of Takrarishta yukta Mustadi Kwatha Madhutailika Basti in the management of Sthaulya (Obesity): A single-arm clinical study.

Dr Kinjal Pannalal Bochiya1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月10日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
1.Hemogram

研究概览

简要总结

Obesity is a mild state of chronic inflammation of adipose tissue and a state of malnutrition by excess, which leads to a defective hormonal and immune system. â€œAshtau Ninditiya” chapter described in the beginning of Yojana Chatushka of Charak Samhita states about types of bodies which are deficient in the context of health. Atisthula is one such condition which can be corelated with obesity in modern science.A study published in Lancet rates India to be among top three most obese nations stating 70% population overweight. The Lancet study also revealed that 30 million adults in India are either overweight or obese, and 62 million diabetic Indians exhibit obesity-related characteristics such as excess body fat, abdominal adiposity, and fat deposition in ectopic sites. Medicines, diet regulation, exercises, stress management, bariatric surgeries are the current trends followed to reduce obesity. Even though several approaches are stated to benefit, the spectrum of problem is growing. Hence yet, a satisfactory solution is awaited. in the study one such solutation is being carried upon, to solve the current problem.

in the study subjects will be selected according to Inclusion and Exclusion Criteria as mentioned, then after taking the concent subjects will be treated with Takrarishta Yukta Mustadi Kwatha Madhutailika Basti for eight days consisting 2 anuvasan(first and eighth) and 6 niruh(second to seventh). Further follow up will be taken on 8th,15th,21st, 30th day according to the subjective and objective criteria.

This study will be useful in stating a definitive treatment for obesity in the present era using Takrarishta Yukta Mustadi Kwatha Madhutailika Basti.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • 1 Age: 18 to 60 yrs 2 Participants with clinical signs and symptoms of Sthaulya irrespective of gender, caste & religion, who are willing to give consent and get enrolled for the study.
  • 3 B.M.I criteria from 30 kg/m2 to 35 kg/m2.

排除标准

  • 1 Participants below 18 years of age and above 60 years of age 2 Pregnant and lactating women 3 Participant with uncontrolled hypertension, diabetes, and other comorbidity 4 Participant diagnosed HIV and HbsAg 5 Participant on hormonal therapies.

结局指标

主要结局

1.Hemogram

时间窗: 1st Day And 30th Day

2.ESR

时间窗: 1st Day And 30th Day

3.Lipid Profile

时间窗: 1st Day And 30th Day

4.LFT

时间窗: 1st Day And 30th Day

次要结局

  • 1.Shrama Shwasa/Kshudra Shwasa(Dyspnea)(2.Atikshudha (Excessive appetite))

研究者

发起方
Dr Kinjal Pannalal Bochiya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kinjal Pannalal Bochiya

G. J. Patel Institute of Ayurvedic Studies and Research

研究点 (1)

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