A study protocol for assessing the efficacy of add-on Brihatkataphaladi Vati, Vasadi Kashaya and polyherbal nebulization in the management of chronic obstructive pulmonary disease: a randomized placebo-controlled clinical trial

Background: Chronic obstructive pulmonary disease (COPD), correlated with Tamaka Shwasa in Ayurveda, is a major global health concern characterized by persistent airflow obstruction. Conventional treatment provides symptomatic relief and reduces exacerbations but has limited effects on disease progression. Ayurveda interventions with potential anti-inflammatory, mucolytic, and broncho-dilatory properties may offer complementary benefits. This study aims to evaluate the efficacy and safety of add-on Brihatkataphaladi Vati, Vasadi Kashaya, and polyherbal nebulization alongside standard care in COPD. Methods: This randomized, placebo-controlled, parallel-group clinical trial will include 50 clinically stable COPD patients classified as GOLD Grades I-III. Participants will be randomly allocated into two groups of 25 each. The intervention group will receive Brihatkataphaladi Vati, Vasadi Kashaya, and polyherbal nebulization alongside standard care, whereas the control group will receive placebo alongside standard care. Treatment will continue for 90 days, with weekly follow-ups and two post-treatment follow-up visits. The primary outcome will be the change in COPD symptom severity measured using the COPD assessment test (CAT) score. Secondary outcomes will include changes in forced expiratory volume in one second (FEV₁), FEV₁/FVC ratio, exacerbation and hospitalization frequency, rescue medication use, Ayurvedic symptom scores, and safety parameters assessed through clinical monitoring and laboratory investigations. Outcomes will be assessed at baseline and post-treatment. Appropriate statistical tests will be applied, with p<0.05 considered statistically significant. Conclusions: The study is expected to provide evidence regarding the efficacy and safety of this integrative therapeutic approach in improving symptoms and pulmonary function in COPD patients. Trial Registration: The trial is registered with Clinical trial registry of India (CTRI) CTRI/2026/05/110230.