A TWO ARM RANDOMIZED PLACEBO CONTROL TRIAL TO UNDERSTAND UTILITY OF PSYCHOSOMATIC PSYCHODYNAMIC STUDY FOR HOMOEOPATHIC CONSTITUTIONAL REMEDY FOR ADULT FEMALE WITH IRRITABLE BOWEL SYNDROME
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- To identify psychosomatic and psychodynamic patterns in adult females suffering from Irritable Bowel Syndrome (IBS).
研究概览
简要总结
A two arm randomized single blind , placebo controlled clinical trail at Swasthya Kalyan homoeopathic college , Jaipur to assess the role of psychosomatic - psychodynamic understanding in selecting individualized homoeopathic remedies for adult females with IBS diagnosed by ROME IV criteria . After screening and consent , participants will be randomized to receive either individualized homeopathy or placebo for 3 months with regular follow up. Symptom change will be measured using IBS SSS. The study expects significant improvement in IBS symptoms with individualized homoeopathic management
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosed case of IBS Must fulfil ROME IV diagnostic criteria Minimum 3 months of continuous IBS symptoms Participants must exhibit psychosomatic or psychodynamic features, identified through a brief psychological interview or screening.
排除标准
- •Presence of any organic gastrointestinal disease Diagnosed with severe psychiatric disorder- Schizophrenia, Bipolar Disorder, Severe Depression requiring hospitalization or drug therapy Pregnant or breastfeeding females On long term corticosteroids, opioids, or other medications.
结局指标
主要结局
To identify psychosomatic and psychodynamic patterns in adult females suffering from Irritable Bowel Syndrome (IBS).
时间窗: 12 MONTH
次要结局
- To select individualized homoeopathic constitutional remedies based on psychosomatic-psychodynamic evaluation(12 MONTH)
- To compare the effectiveness of the individualized homoeopathic remedy with a placebo in managing IBS symptoms(12 MONTH)
研究者
Deeksha singh
Swasthya Kalyan Homoeopathic Medical College And Research Centre, Jaipur