Clinical Study to Determine the Efficacy of Darvyadi Leha in the Management of Pandu roga w.s.r to Iron Deficiency Anemia in Children
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effectiveness of darvyadi leha in Pandu roga
研究概览
简要总结
This Study is about CLINICAL STUDY TO DETERMINE THE EFFICACY OF DARVYADI LEHA IN
THE MANAGEMENT OF PANDU ROGA W.S.R. TO IRON DEFICIENCY ANEMIA
IN CHILDREN .There will be 2 Groups of a study,
In Group A - Darvyadi Leha will be given = 15mg/kg/day with anupana Madgu and Ghrit = OD
In Group B - Iron and folic acid tablets will be given = 1Tablet/day (100mg elemental
Iron and 500 mcg folic acid) with anupana Water = OD
Trial will be conduct for a period of 8 weeks and Follow up of the case will be after every 2nd week
days that is 4 times ( At 2nd week ,At 4week ,At 6th week ,At 8th week ) during treatment. Final assessment will be
done after completion of 8th week of treatment course on the basis of subjective, objective
assessment and laboratory investigation.
The results and observation will be analyzed and presented in accordance with the respective and applicable statistical test .
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children whose parents are willing to give consent/assent for clinical trial.
- •Children aged between 6-12 years of either sex.
- •Children with Iron Deficiency Anemia(Hb between 7 gm% to 11.9 gm %).
排除标准
- •Children suffering from major systemic illness necessitating long term treatment.
- •Children with evidence of malignancy.
- •Co-morbidity like TB, UTI and bleeding disorders etc.
- •H/o hypersensitivity to any of the trial drug or their ingredients.
- •Children who have completed participation in any other clinical trial during the past six months.
- •Children with blood Hb less than 7gm/dl
- •Children Age below 6 years and above 12 years of either sex.
结局指标
主要结局
Effectiveness of darvyadi leha in Pandu roga
时间窗: 8 Week
次要结局
- Compare bothe drugs Darvyadi leha & Iron & folic acid tablet(8th Week)
研究者
Dr Naval Kishor Gurjar
Madan Mohan Malviya Government Ayurved College Udaipur