“Effect of Kalingadi Churna (in constipation predominant) and Dadimastaka Churna (in diarrhea predominant) in Irritable Bowel Syndrome –A Randomized Controlled Clinical Trialâ€
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- IBS Adequate Relief
研究概览
简要总结
Irritable bowel syndrome (IBS) is one of the most common functional bowel disorders, with prevalence of 11.2% globally and varying from 4.2% -7.5% in India .IBS being a multifactorial disease, presents with symptoms like abdominal pain, stool irregularities, and bloating associated with somatic, visceral and psychiatric comorbidities.
Despite the recent advances, pathophysiology of IBS is not clearly established. So conventional medicine is managing IBS through antispasmodics, antidiarrheals and laxatives symptomatically which on long term are leading to deleterious side effects.
This suggests the need of studies on new drugs and disease modifying treatments which help in reducing the recurrence of IBS and also to improve the quality of life without any adverse effects. In an attempt to fill this lacuna, current study is planned with kalingadi churna & Dadimashtaka churna in management of IBS. IBS manifestations and pathology are similar to the Grahani roga explained in Ayurveda
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals between the age group of 20 to 60 years patients of either sex subjects fulfilling the diagnostic Rome 4 criteria.
排除标准
- •Other subtypes of IBS like mixed and unclassified Diagnosed with Inflammatory bowel disorders Known case of CA colon, Intestinal tuberculosis Patients with chronic alcoholism Patients with any co-morbidities needs long term drug treatment, rheumatoid arthritis, tuberculosis, uncontrolled diabetes, HTN, etc.
- •Pregnant or lactating women .
- •Patient have an allergic reaction to Mebeverine in the past.
- •Patients on any medications for the management of IBS in the last 30 days.
结局指标
主要结局
IBS Adequate Relief
时间窗: 60 days
IBS symptom severity score
时间窗: 60 days
次要结局
- Gastrointestinal Symptom Rating Scale (GSRS) IBS –Visual Analogue Scale (IBS-VAS) Complete Spontaneous Bowel Movements (CSBMs) Bristol Stool Form (BSF) Hamilton Anxiety Rating scale Hamilton Depression Rating scale IBS quality of life (IBS–Qol)(Stool Examination, Interleukin -6 (IL-6))