Randomised controlled trial to evaluate the efficacy of Rajanyadi churna in management of Balatisar with reference to acute diarrhoea in children of age group 1 to 5 years
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Reduction in Udarashoola
研究概览
简要总结
The present randomized parallel-group, open-label clinical trial aims to evaluate the efficacy of a classical Ayurvedic formulation, Rajanyadi churna in the management of Balatisar and compare its effects with kutajtwakchurna another classical formulation. A total of 76 participants diagnosed with Balatisar will be recruited and randomly allocated into two groups.
Participants in the intervention group will receive Rajanyadi churna 600mg to 3000mg bd in powder form, while the comparator group will receive kutajtwakchurna bd for a duration of 5 days. Clinical assessments will be performed on 0th,3rd,5th day
The primary outcome measures include reduction in classical symptoms associated with Balatisar udarashoola, Daurbalya,and Degree of Dehydration.
Objective parameters including malavega ,udarashoola,Daubarlya,Malaswaroopa,Degree of Dehydration.
The study aims to generate scientific evidence regarding the effectiveness of classical Ayurvedic formulations in the management of Balatisar and may provide a safe and cost-effective therapeutic option for patients.
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
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria 1.Children with classical signs and symptoms of Balatisar (diarrhoea) .
- •2.Children aged above 1 years upto 5 years, irrespective of gender, socioeconomic background and religion.
- •3.parents of children willing to give written consent .
排除标准
- •Exclusion Criteria 1.Children exhibiting moderate to severe dehydration .
- •2.Children with known case of systemic illnesses, congenital abnormalities, metabolic disorders, or immunodeficiency conditions.
- •3.Children who require in-patient hospital care for their condition.
结局指标
主要结局
Reduction in Udarashoola
时间窗: 2 Days
Daurbalya and Degree of Dehydration
时间窗: 2 Days
次要结局
- Changes in associated symptoms of(Malavega)
研究者
KIRAN RAMESH MUDGIRE
PMT’S AYURVED COLLEGE SHEVGAON