A Randomized Controlled Clinical Study to evaluate the efficacy of Gomutra Triphala vati in the management of Sthoulya.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The effect of the treatment will be assessed based on detailed case proforma adopting standard scoring methods of subjective parameters such as •Atikshudha
研究概览
简要总结
This is a randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati in the management of sthoulya for a duration of 60 days 60 patients in OPD and IPD of PG studies in Kayachikitsa of Alvas Ayurveda Medical College and hospital , Moodbidri vidyagiri Dakshina Kannada, Karnataka ,India. Assesment will be done based on detailed case proforma adopting standard scoring methods of Subjective and Objective parameters
Pre and Post assesment will be done. Clinical Symptoms will be graded and scores will be given accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having BMI ranging from 125 to 29.9 Kg/m2( Over weight ) 230 to 34.9 Kg/m2(Class one Obesity ) Associated with any two of the below mentioned features 1Atikshudha 2Atisweda 3Atinidra 4Alasya/ Utsaha hani 5Atipipasa 6Alpa shwasa 7Daurgandhya 8Chala Sphik ,Udara, Stana 9Subjects who are ready to give written informed consent.
排除标准
- •1Subjects who are known case of Diabetes Mellitus, Hypertension, Ischemic Heart Disease or any other Systemic diseases.
- •2Obese patients with known Endocrine Dysfunctions.
- •3Pregnant women and Lactating mothers.
结局指标
主要结局
The effect of the treatment will be assessed based on detailed case proforma adopting standard scoring methods of subjective parameters such as •Atikshudha
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Atisweda
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
and objective parameters such as •Body Weight
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Waist Hip ratio
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
pre and post interventional assessment will be done.
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Atinidra
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Alasya/ Utsaha hani
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Atipipasa
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Alpa shwasa
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Daurgandhya
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Chala Sphik ,Udara, Stana
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•BMI
时间窗: The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
次要结局
未报告次要终点