MedPath

To observe the effect of Ayurvedic Medicine for the treatment of Chronic Cough

Not Applicable
Conditions
Health Condition 1: null- Kasa (Stable Chronic Bronchitis)
Registration Number
CTRI/2018/01/011549
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1 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)

2 Stable symptoms for the past 2 weeks i.e. unchanged amount & colour of daily sputum

3 FEV1 > 80%

4 Patient willing and able to participate in the study for 16 weeks

Exclusion Criteria

1.Any other pulmonary diagnosis like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.

2.Patients of Diabetes Mellitus

3.Patients with poorly controlled Hypertension (equal or more than 160 / 100 mmHg).

4.Patients 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.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc).

6.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

7.Symptomatic patients with clinical evidence of Heart failure.

8.Patients with concurrent serious hepatic disorder (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).

9.Smokers/alcoholics and/or drug abusers.

10.Patients who have completed participation in any other clinical trial during the past six (06) months.

11.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1 Change in Leicester Cough Questionnaire (LCQ) Scores. <br/ ><br>2 Number of patients who did not have any episode of acute exacerbation from baseline to end point. <br/ ><br> <br/ ><br>Timepoint: At baseline <br/ ><br>During Treatment (After Every 14 days) <br/ ><br>At the end of treatment <br/ ><br>After follow up of 4 weeks
Secondary Outcome Measures
NameTimeMethod
1 Quality of life outcome from St. Georgeâ??s Respiratory Questionnaire (SGRQ) Score. <br/ ><br>2 Functional Exercise capacity <br/ ><br>3 Any adverse Events <br/ ><br>Timepoint: At baseline <br/ ><br>During Treatment (After Every 14 days) <br/ ><br>At the end of treatment <br/ ><br>After follow up of 4 weeks
© Copyright 2025. All Rights Reserved by MedPath