CTRI/2024/07/070724尚未招募2/3 期
Randomized controlled clinical trial to study the add on effect of Mustadi Ghana Vati along with lifestyle (diet and exercise) modification in Sthaulya with special reference to Obesity in children of age 12 to 16 years.
Amruta Surwase1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月19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
- 60
- 试验地点
- 1
- 主要终点
- To reduce the over weight with the drug mustadi ghanavati in Sthaulya
研究概览
简要总结
This is randomised controlled clinical trail to study in which ayurvedic formulation will be provided to 30 patients showing signs and symptoms of sthaulya and other group of 30 patients will be on diet and exercise . The age group taken for study trial will be between 12 Years to 16 Years and the total duration of study will be 1 year . Final conclusion will be drawn on the basis of statistical method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 12-16 years of age of either sex.
- •Patients presenting with sign and symptoms of sthaulya.
- •(Kshudrashwas, Kshudhadhikya, Trushna, Moha, Daurbalya, Alpaprana etc.).
排除标准
- •Patients with known case of major systemic disorders or other illness which interfere with the present study.
- •Patients with known case of Endocrinal disorders like hypothyroidism, Cushing syndrome and genetic syndromes.
- •Children with known case of drug induced obesity.
- •Withdrawal Criteria – Patients will be withdrawn from the study group if-
- •Children not following instruction more than 5 days will be withdrawn from the study.
- •Any adverse drug reaction occurs.
- •The children not willing to continue the trial.
- •Rescue drug will be given if any major Systemic disorder occurs.
结局指标
主要结局
To reduce the over weight with the drug mustadi ghanavati in Sthaulya
时间窗: 3 months
次要结局
- 1. To reduce the over weight in 3 months(2. To know the characteristics of mustadi ghanvati.)
研究者
Amruta Surwase
LRP medical college
研究点 (1)
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