Comparative Clinical Study to evaluate the efficacy of Lodhradi Churna with Balchaturbhadra Churna in the management of Pittaj Atisara in children of age group 1 to 5 Years.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of lodhradi churna and balchaturbhadra Churna in the management of pittaj atisara in children of age group 1 to 5 years.
研究概览
简要总结
This comparative clinical study aims to assess the efficacy of Lodhradi Churna with Balchaturbhadra Churna in managing Pittaj Atisara in children of age group 1 to five years.
The study will consists of two trial groups, each with 40 patients, who will receive either Lodhradi Churna or Balchaturbhadra Churna along with Madhu for 7 days according to predefined assessment criteria.
Simple random sampling will be used to assign patients to each group and dosing will be determined based on patients age according to Dilling formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •The study will select patients of age group 1 to 5 years, regardless of gender, socioeconomic status, or food habits.
- •Eligible patients will exhibit at least classical symptoms of Pittaj Atisara, including Harit, Pita, Asita Malpravrutti, Trushna, Dahaa, Murchha, Udarsool, Jwara, Durgandhit Mala, and Sweda.
- •Additionally, patients with more than three episodes of loose motions in 24 hours, acute diarrhea with mild dehydration, and whose parents or guardians provide written consent and assent for participation in the clinical trial will be included.
排除标准
- •Patients having any chronic or systemic illness.
- •Patients of moderate to severe dehydration.
- •Patients suffering from Pravahika, Visuchika and Rakta atisara.
- •Patients suffering from chronic diarrhoea, persistent diarrhoea or diarrhoea due to congenital or acquired immunodeficiency.
- •Patients having major problems which require surgical corrections like intussusception and any other.
- •Patients with malabsorption syndrome.
- •Patients having diarrhoea due to lactose intolerence.
结局指标
主要结局
To evaluate efficacy of lodhradi churna and balchaturbhadra Churna in the management of pittaj atisara in children of age group 1 to 5 years.
时间窗: Treatment will be given for 7 days. | Lodhradi churna will be given for one group and balchaturbhadra Churna will be given for another group. | Follow up and assessment will be done on 3rd, 5th and 7th day. | Final observation will be recorded after completion of treatment.
次要结局
- Literature study of pittaj atisara in paediatric age(group.)
研究者
Dr Vivek Gitaram Chothe
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028