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临床试验/CTRI/2025/12/099141
CTRI/2025/12/099141尚未招募2 期

A Randomized Placebo- Controlled trial to evaluate the effectiveness of Individalized Homeopathic Intervention in Constipation among Paediatric age group

JIMS Homeopathic Medical College And Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年1月14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
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

发起方
JIMS Homeopathic Medical College And Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Konda Sai Sharanya

JIMS Homeopathic Medical College And Hospital

研究点 (1)

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