A clinical study to evaluate the therapeutic efficacy of Safuf Zarishk in the management of Ishal Dimaghi (Diarrhoea dominant Irritable Bowel Syndrome)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Change in stool frequency.
研究概览
简要总结
Iritable Bowel Syndrome, also referred to as Functional Bowel Syndrome, is the cluster of symptoms including abdominal pain, bloating, diarrhoea, flatulence and constipation, in absence of any structural or inflammatory abnormalities . Since there are no reliable biological and structural markers that have been yet identified, the treatment therapy is assessed by the questionnaire. In the United states of America, it happens to be one of the top ten reasons for visits to the primary care physicians . Globally, about 10-20% of the adults and adolescents have symptoms in accordance with IBS symptoms . In the Kashmir valley, 24.9% of the general population is diagnosed with IBS . The global prevalence of IBS-D is 31.5% with ROME IV criteria The usual pharmacological treatment approach is on reducing symptom severity and the drugs used usually come with a lot of side effects. Also, less than one-third of IBS patients are satisfied with their present therapy, and 34% of them report no symptom management, therefore more potent treatments are neededThere needs to be the validation of more number of the safe and efficient unani drugs that act upon on the symptoms and synergistically target upon the hypothetical multifactorial pathologies. This approach will result in a long term relief, improve the burden of IBS-D related symptoms and improve the quality of life. This study will aim upon the same facts and hence a trial on efficacy of the unani formulation Safu f Zarishk will be evaluated, primarily on the stool urgency and frequency and secondarily on global IBS - D symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients diagnosed as the cases of IBS-D as per the ROME IV criteria .
- •History of chronic recurrent symptoms and patient doesn’t have adequate relief of the global IBS symptoms at the time of screening.
- •Normal screening tests.
排除标准
- •1• Deranged screening tests.
- •2• Acute onset of symptoms.
- •3• History of bleeding PR.
- •4• Nocturnal diarrhoea.
- •5• Weight loss associated with diarrhoea.
- •6• Known cases of colon carcinoma, celiac disease, lactose intolerance and inflammatory bowel disease or any other organic disease of the GI system.
- •7• Constipation dominant IBS.
- •8• Patients who had taken any type of medications for the relief of diarrhoea and other symptoms at the time of screening including any kind of probiotic, antibiotic or opioids.
- •9• Pregnancy and lactation, females planning for the pregnancy.
- •10• Uncontrolled hypertension and Diabetes.
- •11• Hepatic or kidney diseases.
结局指标
主要结局
1. Change in stool frequency.
时间窗: 30 days
2. Change in the stool consistency.
时间窗: 30 days
3. Change in stool urgency.
时间窗: 30 days
4. Improvement in abdominal pain
时间窗: 30 days
次要结局
- 1. Overall satisfaction with the treatment and improvement in associated symptoms like bloating and discomfort ( IBSS-S and Birmingham IBS system questionnaire)(2. Safety outcomes of the test drug ( through biochemical evaluation ))
研究者
Dr Shameem Ahmad Rather
Regional Research Institute of Unani Medicine (RRIUM ), Srinagar
