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临床试验/CTRI/2024/11/076149
CTRI/2024/11/076149尚未招募2 期

Clinical evaluation of Rasanjana vati in Sthaulya(obesity)

Mansi1 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11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Relief in subjective parameters:

研究概览

简要总结

THIS IS AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE EFFECT OF RASANJANA IN THE FORM OF VATI FOR THE MANAGEMENT OF STHAULYA (OBESITY). It will be a clinical study of 30 patients suffering from obesity. Patient will be selected randomly irrespective of their gender, race, religion, occupation. Patients with classical features of Sthaulya attending the OPD/IPD of Kayachikitsa Department of Quadra Institute Of Ayurveda and Hospital, Roorkee will be selected for this clinical study. The patients between the age group of 20 to 50 years of age  will be selected. The assessment of the trial will be done on the basis of subjective and objective parameters. The period of study is 18 months and duration of study is 2 months. Data depending upon above subjective and objective criteria and other variables will be collected and analyzed statistically.

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
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients having sign and symptoms of sthaulya as explained in ayurvedic texts
  • Patients within the age range of 20 to 50 years
  • Patients of any gender
  • Patients having BMI range of 25 to 40 kilogram per metersquare (i.e., overweight, obesity class 1 and class 2).

排除标准

  • Patients having age of less than 20 years or greater than 50 years
  • Patients having BMI less than 25 kilogram per metersquare and greater than 40 kilogram per metersquare
  • Patients with known history of genetic syndrome and having major systemic disorders such as pulmonary diseases, HTN and DM, hepatic diseases, renal diseases and other endocrine disorders
  • Patients with past surgical intervention for obesity
  • Pregnant and lactating women.

结局指标

主要结局

Relief in subjective parameters:

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

1.Chalasphika Udara Stana

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

2.Alasya

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

3.Dourbalyata

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

4.Swedadikyata

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

5.Daurgandhyta

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

6.Kshudraswasa

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

7.Atinidra

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

8.Atipipasa

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

9.Kshudhaatimatram

时间窗: First follow up- after 15 days of first trial. | Second follow up- after 15 days of first follow up. | Third follow up- after 15 days of second follow up. | Fourth follow up- after 15 days of third follow up

次要结局

  • Relief in objective parameters:(1.Body weight)

研究者

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

Mansi

Quadra Institute Of Ayurveda And Hospital Roorkee Haridwar

研究点 (1)

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