CTRI/2014/09/005066尚未招募2 期
CLINICAL EVALUATION OF KUTAJARISHTA IN THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME (IBS) - KIMIBS
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
- •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.
- •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.
研究者
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