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临床试验/CTRI/2018/02/012020
CTRI/2018/02/012020招募中2/3 期

A Comparative Clinical Study on Guduchi Bhadramustadi Lekhana Basti and Guduchi Bhadramustadi Ghan vatiin the management of sthoulya w.s.r to obesity

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年8月8日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
30
试验地点
1
主要终点
improvement in subjective and objective parameter

研究概览

简要总结

Obesity is common but often underestimated condition of clinical and public health importance in many countries around the world. Obesity is defined as a condition of abnormal or excessive fat accumulation in adipose tissue,to the extent that health is impaired. In Ayurveda Sthula Purusha (obese person) is considered as one of the Nindita Purusha. Acharya Charaka has explained the Swasth Purusha as Samamamsa, Samapramana, Samasahnana and having DridhaIndriya but Sthoul Purusha is not having such qualities while Sushruta said that Sthula is Sadatura (permanent patient) and need regular and continuous treatment. In Ayurveda Sthoulya is one of the Santarpanoth Vayadi and line of treatment of Santarpamoth Vayadhi  is Aptarpana. In Sthoulya Aptarpana can be done mainly by Sanshodhana particularly Ruksha and Tikshana Basti. Thirty patients (15 patients in each group) suffering with Sthoulya (obesity) fulfilling the inclusion and diagnostic criteria will be selected from O.P.D. and I.P.D. of, N.I.A. Jaipur by simple randomized method. The patients are equally divided and randomized divided into two groups with 15 patients each viz. group A Guduchibhadramustadi lekhana basti and in group B Guduchibhadramustadi Ghana vati . Written consent will be taken from the patient before starting trial. Assessment will be done before treatment, after treatment and during last follow up. Observations and results of the treatments will be compared and statistically tested. Conclusion will be drawn on the basis of observations and finding of statistical analysis.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

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

入选标准

  • Age between 16-70yrs suffering from Sthoulya irrespective of religion sex occupation etc.
  • Patients who fulfill the criteria of Sthoulya Patients who are fit for Basti.
  • BMI> 25kg/m2 To 35kg/m2.

排除标准

  • Patients below the age of 16 years and above 70years. Patients with long term steroid treatment. Patients with uncontrolled hypertension, uncontrolled diabetes mellitus. Patients with evidence of severe renal, hepatic and cardiac diseases. Pregnant women and lactating mother. Patients who have any severe metabolic disorder. BMI.

结局指标

主要结局

improvement in subjective and objective parameter

时间窗: 3 month

次要结局

  • Overall effect of the treatment in the management of Sthaulya(1 year 6 months)

研究者

申办方类型
Government medical college

研究点 (1)

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