CTRI/2015/01/005455
Recruiting
Phase 2
Clinical evaluation of Kushmandak Rasayana in the management of Chronic Bronchitis (Kaphaja kasa) - CKMCB
Central Council for Research in Ayurvedic Sciences CCRAS0 sites195 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Central Council for Research in Ayurvedic Sciences CCRAS
- Enrollment
- 195
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Patients of either sex aged between 18 to 70 years.
- •2 Patients with documented history of stable Chronic Bronchitis having persistent cough that produces sputum and mucus most of the days, for \>\= three months per year for \>\= 2 consecutive years.
- •3 Patients having FEV 1 between 50% \-80% of predicted value.
- •4 Patient willing and able to participate in the study for 14 weeks.
Exclusion Criteria
- •1 Presence of other pulmonary diseases or allergies like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Bronchial Asthma, Cystic fibrosis, Tuberculosis, Lung cancer, Pulmonary eosinophilia etc.
- •2 Patients having pulmonary infections other than Chronic Bronchitis.
- •3 Diabetes Mellitus
- •4 Patients on prolonged (over 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.
- •5 Patients suffering from major systemic illness necessitating long term drug treatment
- •(Rheumatoid arthritis, Tuberculosis, Psycho Neuro Endocrinal disorders, etc.)
- •6 Patients with past history of unstable cardiovascular diseases.
- •7 Patients with concurrent serious hepatic disorder defined as Aspartate AminoTransferase (AST) and or Alanine Amino Transferase (ALT), defined as over 2 times upper normal limit or Renal Disorders (defined as Serum Creatinine more then 1\.2 mgdL).
- •8 Alcoholics and or drug abusers.
- •9\.History of hypersensitivity to the trial drug or any of its ingredients.
Outcomes
Primary Outcomes
Not specified
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