Evaluation of efficacy of Haritaki Vati (Terminalia Chebula Retz) Vs Routine care in the management of Sthaulya (overweight)- RCT
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and
研究概览
简要总结
The volunteers will be informed about the study protocol. willing participants will be randomly selected as per lottery method. clinical research format will be prepared and validated. prior to the study approval will be taken from IEC, MGACHRC salod hirapur Wardha and CTRI registration will be done. After selection, participants will be tested individually and selected according to selection criteria. they have divided into two groups the trial is a parallel-group, randomized double blind double dummy clinical standard control trial. it will include 90 days treatment period and 90th day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double
入排标准
- 年龄范围
- 19.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients willing to Participate in the Study and give written informed consent 2 Age between 19 to 30 years of either sex 3 Patients having BMI in between 25 to 29.9 kilogram meter square.
排除标准
- •1 Drug induced overweight.
- •2 Subject who is on anti-lipidemic, steroid medication.
- •3 K/C/O Hypothyroidism, Diabetes, Cardiovascular, Renal disorder, hypertension.
- •4 Pregnant and lactating women.
- •5 Subjects with any serious concomitant illnesses or any systemic illness that is clinically significant and requires a high dosage of medicine.
- •6 Subjects with a history of alcohol consumption, drug dependence, or dependence on caffeine or nicotine.
- •7 Subjects who are going to gym.
结局指标
主要结局
To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and
时间窗: To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and | waist circumference of both the groups on 0th 30th 60th and 90th day of treatment
waist circumference of both the groups on 0th 30th 60th and 90th day of treatment
时间窗: To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and | waist circumference of both the groups on 0th 30th 60th and 90th day of treatment
次要结局
- To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and(waist circumference of both the groups on 0th 30th 60th and 90th day of treatment)
研究者
Dr Vishal Chinchone
Mahatma Gandhi Ayurved College Hospital and Research Centre