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临床试验/CTRI/2025/02/080844
CTRI/2025/02/080844尚未招募2 期

A Comparative Clinical Study on Lodhradi Churna and Balchaturbhadra Churna in the management of Balatisara in Children

State Ayurvedic College and Hospital Lucknow1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月21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
40
试验地点
1
主要终点
Improvement in abdominal pain.

研究概览

简要总结

In this research evaluate the efficacy of Lodhradi Churna and Balchaturbhadra Churna in children diarrhoea. Trial drug will be given in 2 group. This research is double blind randomised parallel group comparative study. Maximum 40 subjects will be taken aged between 2 to 10 years. In first group Lodhradi syrup will be given and in second group Balchaturbhadra syrup will be given orally. The total duration of trial is 15 days and follow up will be done at 3rd, 5th, 7th, and 15th day.

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
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients having age between 2 year to 10 years.
  • 2 Patients lying under diagnostic criteria.
  • 3 Patients having mild degree of dehydration.
  • 4 Patients/parents who are willing to participate in trial.
  • 5 Patients having loose and watery stool within 7 days.

排除标准

  • 1 Patient suffering from moderate to severe dehydration.
  • 2 Severe dysentery and high grade fever.
  • 3 Persistent vomiting.
  • 4 Any serious life-threatening disease.
  • 5 Associated with severe systemic disease.
  • 6 Severe case of diarrhea.
  • 7 Patients having persistent loose and watery stool more than 7 days.

结局指标

主要结局

Improvement in abdominal pain.

时间窗: After 15 days of complete clinical trial.

Improvement in frequency/consistency of stool.

时间窗: After 15 days of complete clinical trial.

Improvement in condition of children.

时间窗: After 15 days of complete clinical trial.

次要结局

  • To evaluate the efficacy of Bal chaturbhadra churna and Lodhradi churna(After completing the 15the day of trial.)

研究者

发起方
State Ayurvedic College and Hospital Lucknow
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Dolly Shukla

State Ayurvedic College and Hospital, Lucknow

研究点 (1)

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