Evaluation of an Ayurvedic formulation for treatment of Chronic Cough.

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 195

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.

10 Patients who have completed participation in any other clinical trial during the past

six months.

11 Pregnant or lactating women.

12 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
1 To measure any clinical control by clinical COPD questionaire (CCQ) <br/ ><br>2 Any acute exacerbations during the trial period. <br/ ><br>Timepoint: one Year

Secondary Outcome Measures

Name	Time	Method
1 Improvement functional exercise capacity by 6 minute walk test (6 MWT). <br/ ><br>2 Safety of the drug by observing any adverse events ADR or lab parameters. <br/ ><br>Timepoint: one Year