A CLINICAL STUDY TO SEE THE EFFECT OF VASAVLEHA IN THE TREATMENT OF STABLE CHRONIC BRONCHITIS (JEERNA KASA)
- Conditions
- Health Condition 1: null- Stable Chronic Bronchitis
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 126
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in clinical symptoms of chronic bronchitis.Timepoint: 14th day, 28th day, 42nd day, 56th day, 70th day and 84th day and after 2 weeks of follow up study.
- Secondary Outcome Measures
Name Time Method Change in St. Georgeâ??s Respiratory Questionnaire (SGRQ) scores <br/ ><br>Any acute exacerbations of Bronchitis occuring during the trial period. <br/ ><br>Timepoint: 14th day, 28th day, 42nd day, 56th day, 70th day and 84th day and after 2 weeks of follow up study