An open-label, Randomized, Placebo-controlled Trial to Evaluate the Efficacy of Gambogia and Individualized Homoeopathic Medicines in Irritable Bowel Syndrome
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- IBS Quality of Life questionnaire
研究概览
简要总结
Irritable Bowel Syndrome (IBS) is one of the most frequently encountered gastro-intestinal disorders globally, distressing 10-20% of the adult population. The prevalence is 6-22% in the Western countries, although it is likely to be lower and ranges from 2-17% in the Eastern countries. The prevalence of IBS in North Indian people is around 4% where it poses a considerable burden on the rural adults. Early studies from Asia reported a prevalence of
IBS below 5%. IBS is characterized by recurrent pain abdomen, distension, altered bowel movement (constipation, diarrhea, or both), and a multitude of gastrointestinal complaints. Severe IBS can significantly alter quality of life, disrupt daily activities, and result in inflated healthcare costs. Homeopathy research evidences in IBS remain compromised. We aimed to evaluate its efficacy beyond mere placebo effect in blinded and randomized design
by using validated outcome measures. In this open-label, randomized, placebo-controlled, three parallel arms, clinical trial, 111 eligible patients suffering from IBS will be randomized to receive either homeopathic medicine Gambogia (n=37) in centesimal potencies, or individualized homeopathic medicines in centesimal potencies (n=37), or identical looking placebo (n=37). The patients will be advised to avoid foods which trigger the disease condition like fat diet, cabbage, beans and legumes, to consume fibre rich diet, sour curd and sufficient fluid daily, and to practice yoga, meditation, and exercises daily. Duration of therapy will be 3 months. IBS-QOL questionnaire, IBS Symptoms Severity Score, and EQ-5D-5L questionnaire score and VAS measures will be assessed at baseline, and every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients suffering from IBS, as per Rome IV diagnostic criteria b) Both sexes c) Age 18-65 years d) Literate patients with ability to read Bengali and/or English e)Patients willing to participate in the study and giving written informed consent.
排除标准
- •a) Patients who are too unwell to take part b) Inability to read patient information sheets and/or denied consent to take part c) Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting quality of life d) Any major gastro-intestinal surgery in last 6 months e) Currently receiving standard therapy for IBS and/or homeopathic treatment for any chronic condition(s) f) Pregnant and lactating women g) Self-reported immune compromised conditions h) Substance abuse and/or dependence.
结局指标
主要结局
IBS Quality of Life questionnaire
时间窗: Baseline, every month, up to 3 months
次要结局
- IBS symptom severity score(Baseline, every month, up to 3 months)
- EQ-5D-5L questionnaire score and VAS measure(Baseline, every month, up to 3 months)