Protocol for an Open Labelled Randomised Comparative Clinical Study to Evaluate the Efficacy of Bharangyadi Madhuka versus Talishadi Churna in the Management of Tamaka Shwasa (Bronchial Asthma)

Background: Shwasa roga is a term used in classical texts to describe respiratory disorders. Acharyas have classified all respiratory diseases into five types of Shwasa rogas. Tamak Shwasa is one among them. 1 Tamaka Shwasa is usually correlated with bronchial asthma for having a resemblance in clinical signs and symptoms. Among five shwasa rogas Tamak Shwasa represents a significant burden due to its chronicity, recurrent exacerbations, and the adverse effects of conventional bronchodilator and corticosteroid therapies. While various Ayurvedic interventions have been used to manage this condition, there exists a research gap regarding the comparative evaluation of Bharangyadi Madhuka and Talishadi Churna. Objective: This study aims to evaluate and compare the clinical efficacy and safety of Bharangyadi Madhuka versus Talishadi Churna in the management of Tamaka Shwasa (Bronchial Asthma). Methods: This open-labelled, parallel comparative clinical trial will be conducted at a single center. A total of 60 patients, aged 25–60 years and diagnosed with Tamaka Shwasa (corresponding to mild intermittent or mild persistent asthma per NAEPP criteria), will be enrolled. Subjects will be randomly allocated into two equal groups:  Group A (Intervention): 2 Patients will receive Bharangyadi Madhuka at a dose of 6 gm twice daily (BD) after meals, administered with a vishammatra of madhusarpi (in a 2:1 ratio).  Group B (Comparator):3 Patients will receive Talishadi Churna at a dose of 6 gm BD after meals with honey. The treatment period is 21 days, with follow-up assessments on days 7, 14, and 21 during treatment and further follow-up on days 28, 35, and 42. Outcome assessments include detailed subjective symptom scoring (e.g., frequency, duration, and intensity of dyspnea, cough, and other related symptoms) and objective clinical criteria (such as the presence of wheezing, rhonchi, and accessory muscle use). Laboratory investigations (e.g., Hb, ESR, CRP, AEC, and pulmonary function tests) will be performed at the specified intervals to monitor safety and therapeutic effects. Data analysis will involve computing means, standard deviations, and appropriate statistical tests, with significance set at p < 0.05.