CTRI/2014/06/004704进行中（未招募）3 期
CLINICAL EVALUATION OF VASAVLEHA IN THE MANAGEMENT OF STABLE CHRONIC BRONCHITIS - Nil
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
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. Patient 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 14weeks
排除标准
- •1. Patients suffering from Acute Bronchitis.
- •2. Patients having PEFR < 50% of the predicted value.
- •3. Other pulmonary diseases like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.
- •4. Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250mg/dl)
- •5. Patients with poorly controlled Hypertension ( >160/100mm of Hg)
- •6.Patients on prolonged ( > 6 weeks) medication with corticosteroids,bronchodilators, mast cell stabilizers, anti-depressants,
- •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 disorders (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. 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 Investigator thinks may jeopardize the study.
研究者
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