COMPARATIVE STUDY ON TILADI MODAK AND BAJRADI MODAK IN THE MANAGEMENT OF KARSHYA (UNDERNUTRITION) AS WEIGHT PROMOTOR IN CHILDREN-TWO ARM OPEN LABEL TRIAL
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To study the efficacy of Tiladi Modak & Bajradi Modak in the management of Karshya (Undernutrition) as weight promoter.
研究概览
简要总结
a two arm open labeled clinical trail
group A
Number of Patients - 45
Number of Patients - Open label two arm
Drug on trial- Tiladi Modak
Dose - Will be given in the form of Modak as per Young`s Formula
Anupana - Luke warm water/milk
Route - Oral route
Follow up - Follow up after every 10th day during the study and 45 days after completion of the study.
group B
Number of Patients - 45
Number of Patients - Open label two arm
Drug on trial-Bajradi modak
Dose - Will be given in the form of Modak as per Young`s Formula
Anupana - Luke warm water/milk
Route - Oral route
Follow up - Follow up after every 10th day during the study and 45 days after completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children age group from 1-16 years of both sexes having clinical signs & symptoms of Undernutrition described in Ayurveda classics & modern literature.
- •Patients having weight less than ideal weight for age.
排除标准
- •Children below1 year & above16 years of age.
- •Known cases of systemic disorders like tuberculosis, HIV, Hepatitis, and Carcinoma.
- •Known case of any endocrinal disorder like hyperthyroidism, or food allergy.
- •Known case of inborn error of metabolism (IEM).
结局指标
主要结局
To study the efficacy of Tiladi Modak & Bajradi Modak in the management of Karshya (Undernutrition) as weight promoter.
时间窗: 45 Days
次要结局
- 1. Tiladi Modak & Bajradi Modak will be found effective in increasing over all growth of(children.)
研究者
Dr Sangeeta Kumari
Post Graduate Institute of Ayurveda Jodhpur