跳至主要内容
临床试验/CTRI/2025/03/081999
CTRI/2025/03/081999尚未招募2/3 期

A comparative clinical study to evaluate the role of Lekhana basti and Virechana karma in Sthaulya (obesity).

Department of Panchakarma Ayurvedic and Unani Tibbia College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月20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
30
试验地点
1
主要终点
The proportion of patients showing reduction in BMI, Girth measurements and Skin folds thickness of post lekhana Basti karma and Virechan karma.

研究概览

简要总结

As a lifestyle disease, obesity is among the most prevalent and undertreated disorders in both industrialized and developing nations, according to the World Health Organization,Since obesity is a major risk factor for non-communicable diseases such diabetes mellitus, ischemic heart disease, and cardiovascular disorders, it is typically linked to increased rates of mortality and morbidity The peptide hormone leptin regulates food intake, body mass, and reproductive function and plays a role in fetal growth, proinflammatory immune responses, angiogenesis and lipolysis Leptin resistance is characterized by reduced satiety, overconsumption of nutrients, and increased total body mass. Often this leads to obesity Ayurvedic classics have mentioned Lekhana Basti and Virechana Karma among the Shodhana Chikitsa for Sthaulya. The goal of the current study is to assess the effect of lekhana basti and virechana karma on biomarker serum leptin and gut microbiota ,BMI and hip waist ration .

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

  • pateints with BMI more than or equal to 25 and less than 40.

排除标准

  • The patient having B.M.I. more than 40 kg/m2 FOR GROUP A Patients contraindicated for Basti karma like, Udara rog, intestinal perforation, intestinal obstruction, Pregnant and lactating women.
  • FOR GROUP B Patients contraindicated for virechana karma like Rectal prolapse, lower GI bleeding, Incontinence of stool.
  • Patients with renal (Sr. creatinine more than 1.8mg/dl and Sr. Urea more than 60 mg/dl,) or hepatic impairment (SGOT and SGPT more than Five times of upper limit) Patients with Blood pressure in the range of more than or equal to 160/100mm of Hg) or more, Diabetes Mellitus (having HbA1c more than 7 % with or without hyperglycemic medications.
  • Known case of IHD, CAD, CHF or other major cardiovascular problems will not be included for this study.
  • Patients on anti-tubercular, anti-retroviral, antibiotic medications.
  • Patients requiring emergency treatment.

结局指标

主要结局

The proportion of patients showing reduction in BMI, Girth measurements and Skin folds thickness of post lekhana Basti karma and Virechan karma.

时间窗: Day 0 (group A and B)- subjective and objective parameters will be assessed. Vitals examination, CBC, HbA1c, LFT, KFT and Lipid Profile will be done. | In Group A after lekhana basti and In Group B after virechana Vitals examination, Subjective and Objective Parameters will be assessed. | On Day 30th - (group A & B) Vitals examination, Subjective and Objective Parameters will be assessed. CBC, HbA1c, LFT, KFT and Lipid Profile will be done.

次要结局

  • The proportion of patients showing changes in the serum leptin post lekhana Basti karma & Virechan karma.(The proportion of patients showing changes in the gut microbiome post lekhana Basti karma & Virechan karma.)

研究者

发起方
Department of Panchakarma Ayurvedic and Unani Tibbia College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Jolly Gautam

Ayurvedic and Unani Tibbia college and hospital ,Karol Bagh New Delhi

研究点 (1)

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