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

Clinical Evaluation of Vyaghri Haritaki in the Management of Chronic Bronchitis - IMCRP- BTS-2010-2011

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/02/002427
Enrollment
150
Registered
2012-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Bronchitis

Interventions

Intervention1: Vyaghri Haritaki: Dose-10 gm twice daily Dosage form-Avaleha Route of Administration-Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-300 gm

Sponsors

Central Council for Research in Ayurvedic Sciences CCRAS
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Patients suffering from Acute Bronchitis. 2. Patients having PEFR 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.

Design outcomes

Primary

MeasureTime frame
Change in the clinical symptoms of chronic bronchitis viz: Productive cough, Dyspnoea, Wheezing, Chest pain, Sore throat and Nasal congestionTimepoint: Baseline-14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up of 2 weeks

Secondary

MeasureTime frame
Change in St. Georgeâ??s Respiratory Questionnaire (SGRQ) scoresTimepoint: Baseline-14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up of 2 weeks

Countries

India

Contacts

Public ContactDr Pradeep Dua

Central Council for Research in Ayurvedic Sciences (CCRAS)

duadrpradeep@gmail.com011-28525831

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026