A Randomized Placebo- Controlled trial to evaluate the effectiveness of Individalized Homeopathic Intervention in Constipation among Paediatric age group
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
Constipation is one of the most prevalent gastrointestinal disorders in children significantly affecting their physical comfort psychosocial well-being and overall quality of life Despite standard management strategies including dietary modification behavioral therapy and laxatives many children continue to experience persistent symptoms or recurrence prompting interest in complementary approaches This randomized single-blinded placebo controlled clinical trial aims to evaluate the effectiveness of individualized homeopathic intervention along with dietary management in children aged 5 10 years diagnosed with constipation based on ROME IV criteria A total of 72 participants will be stratified and randomly allocated into two groups Group A receiving individualized homeopathic medicine and Group B receiving placebo both with identical dietary advice Outcomes will be assessed every 21 days for six months using the Modified Constipation Assessment Scale The primary outcome measure is the change in MCAS scores from baseline to completion of the study This trial intends to generate robust clinical evidence regarding the role of individualized homeopathy as an adjunctive therapeutic modality in pediatric constipation and to address the existing research gap through a rigorous methodological design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Children of both sex 5 10 years of age suffering with constipation according to ROME 4 criteria must have straining hard stools incomplete evacuation fewer than three spontaneous bowel movements per week Modified Constipation Assessment Scale total score indicating moderate severe constipation.
排除标准
- •History of surgical intervention for gastrointestinal issues Use of ongoing allopathic treatment for constipation or recent use of laxatives within 2 weeks prior to enrollment.
研究者
Dr Konda Sai Sharanya
JIMS Homeopathic Medical College And Hospital
