A clinical study to see the effect of an Ayurvedic formulation in the management of Chronic Respiratory Infectio

Phase 2

• Conditions: Health Condition 1: null- Chronic Bronchitis

• Registration Number: CTRI/2012/02/002427
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex aged between 16 to 70 years.

2. Patients 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 16 weeks.

Exclusion Criteria

1. Patients suffering from Acute Bronchitis.

2. Patients having PEFR < 50% of the predicted value.

3. Presence of other pulmonary diseases like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.

4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)

5. Patients with poorly controlled Hypertension ( >=160 / 100 mm Hg)

6. 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.

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 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).

11. Smokers/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 Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified