Evaluation of the comparative efficacy of Vidarikand vati (Pueraria tuberosa DC) vs. Ashwagandha vati (Withania somnifera Linn) in Karshya (underweight): Randomized controlled trial.
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 Bruhaniya effect of
研究概览
简要总结
he 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
- 20.00 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 20 to 30 years of either sex 3 Patients having BMI in between 14 to 19 kilogram meter squire 4 Patients having Hemoglobin more then 8 gram per deciliter.
排除标准
- •Patients with acute complications like Cirrhosis of liver Pancreatitis Tuberculosis Diabetes mellitus Diabetes insipidus Hyperthyroidism Severe Anaemia Hb less than 8gm/dl Other systemic diseases like CKD CHD and other Immuno Compromised disease like HIV Rheumatoid arthritis etc.
结局指标
主要结局
To assess the efficacy of Bruhaniya effect of
时间窗: 90 days
Vidarikand vati and ashwagandha vati in BMI body weight arm and
时间窗: 90 days
waist circumference of both the groups on 0th 30th 60th and 90th day of treatment
时间窗: 90 days
次要结局
- To assess the efficacy of Bruhaniya effect of(Vidarikand vati & ashwagandha vati in BMI body weight arm and)
研究者
DrNikita Rathod
Datta Meghe Institute of Higher Education and Research Centre