CTRI/2012/01/002348招募中2 期
Clinical Evaluation of Bilvadi Leha in the Management of Irritable Bowel Syndrome (IBS) - ACT- IBS-2010
Department of AYUSH Ministry of Health Family Welfare Government of India0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
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. Patients of either sex with age between 18 and 65 years
- •2. Known case of IBS as per Rome III criteria :
- •(Symptoms of recurrent abdominal pain or discomfort and a marked change in
- •bowel habit for atleast six months, with symptoms experienced on atleast 3
- •days/month in the last 3 months associated with two or more of the following:
- •Â· Pain is relieved by defecation
- •Â· Onset associated with change of frequencey of stools
- •Â· Onset assoicated with a change in form (appearance) of stools.
- •(Diagnosis to be confirmed by using the IBS module questionnaire)
- •3. Willing and able to participate in the study
排除标准
- •1. Patients with bleeding per rectum.
- •2. Mixed infection with parasites like round worms, hook worms etc.
- •3. Patients with evidence of malignancy
- •4. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP)
- •>200 mg% OR HbA1c > 6.5%}.
- •5. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg)
- •6. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants,
- •anticholinergics, etc. or any other drugs that may have an influence on the
- •outcome of the study.
- •7. Patients suffering from major systemic illness necessitating long term drug
- •treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal
- •disorders, etc.)
- •8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
- •Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •9. Symptomatic patient with clinical evidence of Heart failure.
- •10. Patients with concurrent serious 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), Severe Pulmonary Dysfunction
- •(uncontrolled 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 hypersensitivity to the trial drug or any of its ingredients.
- •13. Pregnant / lactating woman.
- •14. Patients who have completed participation in any other clinical trial during the
- •past six (06) months.
- •15. Any other condition which the Principal Investigator thinks may jeopardize the
研究者
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