Health Condition 1: null- Kasa (Stable Chronic Bronchitis)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age of the patient is between 18 to 65 years. 2.Patients of chronic stable bronchitis suffering from minimum of two years.(Chronic bronchitis is defined clinically as chronic Productive cough for 3 months in each of 2 successive years in that patient in whom other causes of productive cough have been excluded.) 3.Stable symptoms for the past 2 weeks i.e. unchanged amount & color of daily sputum 4. FEV1 of > 80% 5.Patient willing and able to participate in the study for 16 weeks.
Exclusion criteria
Exclusion criteria: 1.Patient is having another diagnosed pulmonary disorder (E.g. Emphysema, cor pulmonale, cyanosis, pneumonia, asthma, cystic fibrosis, tuberculosis, lung cancer etc.) 2.Patient of Diabetes Mellitus 3.Patient is having poorly controlled HTN (BP >= 160/100 mmHg). 4.Patient is 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 5.Patient is suffering from major systemic illness necessitating long term drug treatment (e.g. Rheumatoid arthritis, Tuberculosis & psycho-neuro-endocrinal disorders etc.) 6.Patient is having the past history of atrial fibrillation, acute coronary syndrome, MI, stroke or severe arrhythmia in the last 6 months. 7.Patient is having symptoms of heart failure along with clinical evidences. 8.Patients is suffering from concurrent serious hepatic disorder (AST &/or ALT, Total Bilirubin & ALP > 2 times upper normal limit) or renal disorder (S. creatinine > 1.2 mg/dl). 9.Patient is a smoker/alcoholic &/or drug abuser. 10.Patient has completed participation in another clinical trial during the past six months. 11.Patientâ??s condition which may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Leicester Cough Questionnaire Score, from baseline to endpoint. 2. Number of patients who didnt have any episodes of acute exacerbations from baseline to endpoint. Timepoint: On baseline, 14th day, 28th day, 42th day, 56th day, 70th day, 84th day and 98th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of life outcome from St. Georgeâ??s Respiratory Questionnaire (SGRQ) Score. 2. Functional exercise capacity. 3. Any adverse events. Timepoint: On baseline, 14th day, 28th day, 42th day, 56th day, 70th day, 84th day and 98th day | — |
Countries
India
Contacts
CENTRAL AYURVEDA RESEARCH INSTITUTE FOR RESPIRATORY DISORDERS