CTRI/2025/03/083078尚未招募2 期
A Comparative Clinical Study to evaluate the efficacy of Amritadi Guggulu and Ruksha Udvartana in the Management of Sthaulya W.S.R. Obesity in children.
Madan Mohan Malviya Govt Ayurveda Collage Udaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月20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
- 60
- 试验地点
- 1
- 主要终点
- changes in investigation and subjective parameter
研究概览
简要总结
This study focuses on a pharmacognostical and clinical evaluation of Amritadi Guggulu and Ruksha Udvartana in managing Sthaulya (obesity) in children. The study will consist of two groups:
Group A: Participants will receive Amritadi Guggulu at a dosage of 14 mg/kg/day and Ruksha Udvartana (dry powder) applied for 20 minutes daily, either in the morning or evening on an empty stomach.
Group B: Participants will receive Amritadi Guggulu at a dosage of 14 mg/kg/day without the Ruksha Udvartana.
The trial will be conducted over a period of 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 8.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children whose parents are willing to give consent for clinical trial. 2.Children aged group from 8-16 years having clinical signs & symptoms of childhood obesity described in Ayurveda classics and modern literature. 3.Children with BMI 86th percentile.
- •94th percentile and above 95th percentile. 4.Childrens of both sexes will be considered in the study. 5.Children shows cardinal feature of childhood obesity will be selected.
排除标准
- •Children aged below 7 years and above 16 years of age.
- •Children receiving drugs like steroids and anti- depressants drugs.
- •Childhood obesity due to endocrinal disorders like Cushing syndrome, hypothyroidism etc.
- •Children with BMI below 85th percentile is not considered.
结局指标
主要结局
changes in investigation and subjective parameter
时间窗: 8 week
次要结局
- changes in the subjective parameters(8 weeks)
研究者
Dr Ashok Mundotiya
madan mohan malviya govt collage
研究点 (1)
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