A randomized clinical trial to compare the effectiveness of paraffinum vs individualized homoeopathic medicine in constipation in pediatric age group
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The study is expected to show the effectiveness of Paraffinum as well as individualized
研究概览
简要总结
A randomized clinical trial that aims to compare the effectiveness of Paraffinum versus individualized homeopathic medicines in treating constipation among children aged 4–18 years. The study will use the Constipation Scoring System (CSS) as an outcome tool over three months and seeks to generate evidence-based guidance for homeopathic management of pediatric constipation
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
- 4.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Children age 4-18 years 2 Children of both sex 3 Case of constipation ICD-10-CM K59.0 4 Valid written Consent and Assent from parent/guardian 5 Children with functional constipation as per Rome IV criteria.
- •At least two of the criteria below: Two or fewer defecations in the toilet per week At least 1 episode of fecal incontinence per week (after being toilet trained) History of retentive posturing or excessive voluntary stool retention History of painful or hard bowel movements Presence of a large fecal mass in the rectum History of large-diameter stools that may obstruct the toilet.
排除标准
- •1Age less than 4 and more than 18 2 No consent 3 Organic causes (e.g., Hirschsprung’s) 4 Neurological disorders 4 Severe systemic illnesses.
结局指标
主要结局
The study is expected to show the effectiveness of Paraffinum as well as individualized
时间窗: 3 months
homeopathic medicine in cases of functional constipation in children. as well as s expected to show a comparison of the two groups, pointing out the
时间窗: 3 months
difference in effectiveness in the two groups and medicines used.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Dr Pratishtha Singh Patel
Dr M P K Homoeopathic Medical College Hospital And Research Centre