CTRI/2012/02/002427招募中2 期
Clinical Evaluation of Vyaghri Haritaki in the Management of Chronic Bronchitis - IMCRP- BTS-2010-2011
Central Council for Research in Ayurvedic Sciences CCRAS0 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 aged between 16 to 70 years.
- •2. Patients with history of uncomplicated Chronic Bronchitis. (Chronic Bronchitis is defined as a cough that occurs every day with sputum production that lasts for at least three months, two years in a row).
- •3. Patient willing and able to participate in the study for 16 weeks.
排除标准
- •1. Patients suffering from Acute Bronchitis.
- •2. Patients having PEFR < 50% of the predicted value.
- •3. Presence of other pulmonary diseases like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.
- •4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
- •5. Patients with poorly controlled Hypertension ( >=160 / 100 mm Hg)
- •6. Patients on prolonged ( > 6 weeks) medication with corticosteroids, bronchodilators, Mast cell stabilizers, 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 patients 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).
- •11. Smokers/alcoholics and/or drug abusers.
- •12. H/o hypersensitivity to the trial drug or any of its ingredients.
- •13. Patients who have completed participation in any other clinical trial during the past six (06) months.
- •14. Pregnant or lactating women.
- •15. Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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