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A Clinical Study to Evaluate the Efficacy of Ayurvedic Management As An Add-on to Conventional Medicine in the Management of Chronic Obstructive Pulmonary Disease (COPD)

Efficacy of Whole System Approach of Ayurveda as an Add- on to Conventional Medicine in the Management of Clinical Phenotypes of Chronic Obstructive Pulmonary Disease(Tamaka Shwasa Roga)- A Single Blind Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055736
Enrollment
100
Registered
2023-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

None listed

Sponsors

Institute of Teaching and Research in Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing for trial and ready to give informed consent 2. Patients who have symptomatic stable COPD diagnosis with postbronchodilator FEV1/FVC ratio 3. Patients getting conventional treatment as per allopathic standards 4. GOLD grade I, II and III

Exclusion criteria

Exclusion criteria: 1. Patients not willing for trial. 2. Age more than 70 years or less than 40 years. 3. Patients having bronchial asthma. 4. Patients not getting conventional treatment as per allopathic standards. 5. Patients who have a history of myocardial infarction, heart failure, acute ischemic coronary disease or severe cardiac arrhythmia requiring treatment within the last 6 weeks 6. Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder. 7. Patients with advanced Type II respiratory failure, GOLD grade IV (FEV1% 8. Patients requiring long-term oxygen therapy (LTOT). 9. Patients suffering from major systemic illness necessitating long-term treatment (R.A., malignancy). 10. Poorly controlled hypertensive (BP >180/100 mm of Hg) and diabetic patients (FBS >150mg/dl) 11. Patients having end-stage hepatic dysfunction (AST/ALT > 4 times of upper standard limit), or renal dysfunction (S.creatinine >1.2mg/dl). 12. Patients who are found clinically unfit for Dosha and Bala-specific procedures.

Design outcomes

Primary

MeasureTime frame
Improvement in FEV1, Improvement in COPD Assessment Test (CAT) score. Timepoint: 60 days

Secondary

MeasureTime frame
1. Improvement in signs & symptoms as per grading system 2. Improvement in rate of exacerbation 3. Improvement in FEV1/FVC 4. Improvement in PEFR 5. SPO2 6. Safety profile- Heamatological tests (CBC, ESR) Biochemistry tests (TSB, DSB, AST, ALT, B. Urea, S. Creatinine, FBS, S. Lipid profile) Timepoint: 60 days

Countries

India

Contacts

Public ContactDr Anoza Bhaskar

Institute of Teaching and Research in Ayurveda, Jamnagar

mandipgoyal@itra.edu.in9427572306

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026