A single-arm Clinical Study to evaluate the effectiveness of Virechana followed by Vardhamana Pippali Rasayana in the management of COPD (Tamaka swasa) along with assessing Desmosine level
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- All India Institute of Ayurveda, Delhi
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Changes in clinical presentation along with lung function tests (FEV1/FVC, FEV1%, PEFR)
Overview
Brief Summary
This dissertation proposes a clinical study to see how well an Ayurvedic treatment works for a lung disease called COPD, which is known in Ayurveda as Tamaka Swasa.
The main goal is to check if a specific treatment, which involves Virechana followed by Vardhamana Pippali Rasayana, improves a patient’s symptoms and lung function. A secondary goal is to see if it reduces a biomarker called Desmosine, which shows lung damage. The study also aims to see if the treatment improves the patient’s quality of life and other health scores.
The study is being done because COPD is a big problem worldwide, and regular medicines often just help with symptoms without stopping the disease from getting worse. This research hopes to scientifically prove that traditional Ayurvedic methods can help protect the lungs and keep the condition from progressing.
How the Study Will Be DoneThe study is an exploratory, single-arm clinical trial and will involve 36 people. The treatment will last for 92 days.
Who can participate:
People between 25 and 60 years old.
People diagnosed with Tamaka Swasa.
People with mild to moderate COPD.
People who are willing to go through the treatment.
Who cannot participate:
People with severe or very severe COPD.
Anyone who has had a recent flare-up of the disease.
People with other serious health conditions like lung cancer or uncontrolled diabetes.
Pregnant or breastfeeding women.
People who are currently taking steroids.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Individuals aged between 25 and 60 years.
- •Diagnosed with Tamaka Swasa based on Clinical signs and symptoms like Swasakrichata,kasa,urashoola,ghurghurkam shabada,peenasa,anidra, etc.
- •Classified with mild to moderate COPD according to GOLD criteria.
- •FEV1/FVC ratio is less than 0.70 postbronchodilator, and FEV1 ranges from 50% to 80% of the predicted value.
- •Willing and able to undergo Virechana Karma and Vardhamana Pippali Rasayana.
- •Provided a written informed consent.
Exclusion Criteria
- •Severe or very severe COPD (FEV1 below 50% of predicted) or an acute exacerbation in the last 4 weeks.
- •FEV1/FVC ratio exceeding 0.70 (indicating a non-obstructive pattern)..
- •Severe respiratory distress requiring emergency care, known case of Lung cancer, bronchiectasis, interstitial lung disease, Congenital heart disease, uncontrolled Diabetes mellitus, pneumonia, lung fibrosis, HTN, pneumothorax, and tuberculosis.
- •Women who are pregnant or breastfeeding Individuals who are unfit for Virechana karma and Vardhamana pippali rasayana Patient taking steroid therapy (systemic or inhaled corticosteroid).
Outcomes
Primary Outcomes
Changes in clinical presentation along with lung function tests (FEV1/FVC, FEV1%, PEFR)
Time Frame: Baseline, AT, AF
Secondary Outcomes
- Changes in urine desmosine level(Improvement in quality of life (SF-36))
Investigators
Dr Km Jainab
All india institute of Ayurveda,Delhi