CLINICAL EVALUATION OF KUTAJARISHTA IN THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME (IBS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Assessment of the effect of Kutajarishta on IBS Severity score
研究概览
简要总结
Irritable Bowel Syndrome (IBS) is a highly prevalent condition, affecting 15% of the population. Irritable Bowel Syndrome is a clinical entity recently identified with a set of symptoms related to gastrointestinal tract. These symptoms essentially pertain to the diathesis of gut motility disorder. This characteristic clinical features are abdominal pain, altered bowel habit, psychiatric symptoms such as anxiety or depression in the absence any detectable organic pathology. It is a persistent syndrome intractable to all kinds of treatment and presentation often appears intermingled with a range of personality factors. IBS seems to be apparently comparable to two classical Ayurvedic syndromes described in Samhitas of Ayurveda viz. (1) Vataja Grahani Roga (2) Pakvasayagata Vata. On further, conceptual and clinical studies on IBS and its probable correlates in Ayurveda suggest that the description of Pakvasayagata Vata is very close to IBS, not only symptoms but the site Pakvasaya (Colon) is also common in both the conditions. The current management of IBS is not satisfactory.
Ayurveda in its herbarium has lots of antidiarrhoeal and antibacterial compounds which can fill up this gap. On the textual and on the basis of clinical experience drug Kutajarishta (API- Part II Vol –II: Pg No.39) is selected as antidiarrhoeal and antibacterial agent for the clinical trial in patients of Irritable Bowel Syndrome (IBS). After examining the pharmacological properties and pharmacological actions of constituents of selected Kutajarishta,
The present clinical trial is planned to validate the clinical efficacy and safety of Kutjarishta in the subjects suffering from Irritable Bowel Syndrome (IBS)
Various ingradients of Kutjarishta are:
-
Kutaja (Stem bark of Holarrhena antidysenterica)
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Draksha (Dried fruit of Vitis vinifera)
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Madhuka pushpa (Flowers of Madhuka indica)
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Gambhari (Stem Bark of Gmelina arborea)
-
water for decoction
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Guda (Jaggery)
-
Dahtki pushpa (flowers of Woodfordia fruticosa
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Known case of IBS of subtype mixed( IBS-M) as per Rome III criteria : Recurrent abdominal pain or discomfort for at least 3 months, and symptoms at least 3 days/month associated with two or more of the following: •Relief of pain or discomfort with defecation.
- •â€¢Onset of pain or discomfort associated with a change in form (appearance) of stool (loose or hard stools): Bristol stool form scale of type 1-2 for constipation and type 6-7 for diarrhoea.
- •â€¢Onset of pain or discomfort associated with a change in bowel frequency: ≤ 3 bowel movements per week for constipation and > 3 bowels movements per day for diarrhoea.
- •2.Willing to give written informed consent for the participation.
排除标准
- •1.Known cases of Gastroesophageal Reflux Disease(GERD)/hyperacidity 2.Patients with bleeding per rectum.
- •3.Mixed infection with parasites like round worms, hook worms etc.
- •4.Patients with evidence of malignancy 5.Patients with Diabetes Mellitus {B.S. (F) > 126 mg/dl and / or B.S. (2 hr.
- •PP) >200 mg/dl 6.Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •7.Patients suffering from any systemic illness affecting the bowel habits as assessed by P.I. 8.Patient having history of unstable cardiovascular disease 9.Symptomatic patients with clinical evidence of heart failure.
- •10.Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine >1.2mg/dL), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
- •11.Alcoholics and/or drug abusers.
- •12.H/o inflammatory bowel disease and coeliac disease.
- •13.Family history of gastrointestinal malignancy.
- •14.H/o hypersensitivity to the trial drug or any of its ingredients.
- •15.Pregnant / lactating woman.
- •16.Patients who have completed participation in any other clinical trial during the past six (06) months.
- •Any intestinal pathology which the Investigator thinks may jeopardize the study.
结局指标
主要结局
Assessment of the effect of Kutajarishta on IBS Severity score
时间窗: Time frame:from baseline to on 14th day,28th day,42th day,56th day,and 70th day, end of 12th week and 14th week)
次要结局
- Assessment of the effect of Kutajarishta on WHO-QOL BREF score([Time frame: at base line, at end of 12th week and 14th week])