Individualized homoeopathic medicines in the treatment of functional constipation in children: A double-blind, randomized, placebo-controlled pilot trial using different homoeopathic repertories
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Paediatric Functional Constipation Questionnaire - Parent version
研究概览
简要总结
Functional constipation (FC) is recognized as a significant health issue in children, highlighting the need for early screening and detection. It is recognized as the most common functional gastrointestinal disease in children, where global prevalence is 14.4%. In Asia the prevalence rate is estimated between 5% and 29.6%. And in India the prevalence rate is 17.1%. Homoeopathy is a frequently used therapy to treat functional constipation; however, the research evidence is limited. This 3 months, double-blind, randomized, placebo controlled pilot trial is aimed to explore the feasibility of a definitive future trial and to evaluate whether IHMs can produce significant effects different from placebo in the treatment of functional constipation in 60 children’s. The primary outcomes measure is PaedFCQuest-PR score and secondary outcomes measure are PedsQL, MYMOP-2 questionnaires, all assured at baseline, and every month up to 3 months. The study being pilot in nature and no hypothesis is being tested, no inferential statistics test will be applied. Group differences will be presented using descriptive statistics: means and confidence intervals (CI). Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 5-15 years
- •Patients suffering from functional constipation (ICD10- K59.00) must fulfill the Rome IV criteria (must include 2 or more of the following, occurring at least once per week for a minimum of 1 month with insufficient criteria for a diagnosis of irritable bowel syndrome).
- •Patients who can read and/or understand either Hindi or English or Bengali.
排除标准
- •Not providing with written informed consent and assent form of participation.
- •Patients using any medications that could cause constipation.
- •Patients with IBS
- •Patients having any previous diagnosis/symptoms suggestive serious gastrointestinal disease.
- •Major psychiatric disorder.
- •Cases with red flag signs pertaining to organic disease
- •Significant chronic health conditions requiring speciality care.
- •Diagnosed cases of other systemic disease affecting quality of life.
- •Patients under other medications for any chronic disease.
- •Simultaneous participation in any other clinical trials
- •Self-reported immune-compromised state, AIDS, hepatitis etc.
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
Paediatric Functional Constipation Questionnaire - Parent version
时间窗: Baseline, and every month, up to 3 months
Form (PedFCQuest-PR)
时间窗: Baseline, and every month, up to 3 months
次要结局
- Pediatric quality of life inventory TM (PedsQL) questionnaire(Baseline, and every month, up to 3 months)
- Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) questionnaire(Baseline, and every month, up to 3 months)
研究者
Abdul Karim
D N De Homoeopathic Medical College and Hospital