Effectiveness of individualised homoeopathic medicines in management of irritable bowel syndrome–mixed type (IBS-M): an open label, single arm, prospective, pre-post clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement in IBS Symptom Severity Score (IBS-SSS) and
研究概览
简要总结
This research proposal by Dr. Avaneendra Trigunayat investigates the effectiveness of individualized homoeopathic medicines in managing Irritable Bowel Syndrome–Mixed Type (IBS-M) through an open-label, single-arm, prospective, pre-post clinical study involving 70 participants over 18 months. Conducted at the National Institute of Homoeopathy, Kolkata, and guided by Dr. Pratima Pal, the study aims to assess changes in symptom severity and quality of life using validated tools like IBS-SSS, IBS-QOL, and the Bristol Stool Form Scale. Given the fluctuating nature of IBS-M and limitations of conventional treatments, this study seeks to provide rigorous evidence supporting homoeopathy’s holistic and personalized approach, addressing both physical and psychosomatic dimensions of the disorder.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All religions and races irrespective of socioeconomic status.
- •Confirmed diagnosis of IBS-M as per Rome IV criteria.
- •Patient who understand and willing to give informed consent and adhere to follow up.
排除标准
- •History of IBD, coeliac disease, or colorectal cancer.
- •Use of antibiotics or probiotics in past 2 weeks.
- •Pregnant or lactating women.
- •Psychiatric illness affecting participation.
结局指标
主要结局
Improvement in IBS Symptom Severity Score (IBS-SSS) and
时间窗: At Baseline, 3 Month and 6 Month
Change in Quality of Life (QOL)
时间窗: At Baseline, 3 Month and 6 Month
次要结局
未报告次要终点
研究者
Dr Avaneendra Trigunayat
National Institute Of Homoeopathy