Clinical Validation Study of Unani Pharmacopeial Formulation Qurs e Gulnar in Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D))
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Improvement in the signs and symptoms of Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)). Which will be assessed on the basis of IBS Severity Scoring Scale (IBS-SSS) and Gastrointestinal Symptom Rating Scale (GSRS-IBS).
研究概览
简要总结
This study is designed as a multi-centric open trial in patients with Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)) . After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria. The patients will be assessed clinically at baseline and every two weeks of the protocol treatment. (i.e., 0, 2th, 4th and 6th week) . This includes subjective assessment on the basis of improvement in the signs and symptoms . The total duration of treatment will be 06 weeks. Laboratory parameters for safety assessment will be conducted at baseline, 2nd week and on completion of the protocol therapy (i.e., 0, 2nd and 6th week).
Composition of Qurse Gulnar
| S. No. |
Ingredients
Botanical / Chemical Name
Quantity
|1.
Gulnar
Punica granatum L.
40 g
|2.
Gil-e-Armani
Aluminium silicate
40 g
|3.
*Samagh-e-*Arbi
Acacia nilotica L. Wild ex. Del
40 g
|4.
Gul-e Surkh
Rosa damascene Mill
30 g
|5.
Aqaqiya
Acacia nilotica L. Wild ex. Del
30 g
|6.
Kateera
Cochlospermum religosum (L) Alston
20 g
|7.
Aabe Gulnar
Punica granatum L.
Q.S.
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
- •Based on Rome IV criteria for IBS-D.
- •Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
- •Related to defecation (Pain).
- •Associated with a change in frequency of stool.
- •Associated with a change in form (appearance) of stool.
排除标准
- •Patients below 18 and above 60 years.
- •Known cases of Malignancy, Inflammatory bowel disease (Ulcerative colitis, Crohns disease) and, acute conditions like cholera, gastro-enteritis.
- •Intestinal obstructions, etc.
- •Patients with disease requiring long term treatment e.g., Tuberculosis, Hypertension, Diabetes Mellitus, Malignancy, Liver or Kidney dysfunction, Hypothyroidism, Hyperthyroidism.
- •4.Patients suffering from Amoebic dysentery.
- •5.Diagnosed cases of coeliac disease, bowel resection, other gastrointestinal disorder contributing to the diarrhea, unexplained weight loss or rectal bleeding.
- •6.Use of probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids.
- •Pregnant and lactating women.
结局指标
主要结局
Improvement in the signs and symptoms of Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)). Which will be assessed on the basis of IBS Severity Scoring Scale (IBS-SSS) and Gastrointestinal Symptom Rating Scale (GSRS-IBS).
时间窗: At baseline and every two weeks during the protocol treatment. (i.e., at 0, 2nd, 4th, and 6th week).
次要结局
- Haematological and biochemical investigations for safety assessment i.e.,Haemogram, LFT, KFT, stool and Urine R/M.(At baseline, 2nd week and at the end of protocol treatment.( i.e., 0, 2nd and 6th week))
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)