Efficacy of Induppukaanam Churna in Functional Dyspepsia (Vishtabdha Ajeerna)-An Open Label Double Arm Randomized Controlled Clinical Trial

The present study is an open-label double-arm randomized controlled clinical trial designed to evaluate the efficacy of Induppukaanam Churna in the management of Functional Dyspepsia (Vishtabdha Ajeerna). The formulation comprises four classical ingredients, Saindhava Lavana (Rock salt), Ajamoda (Trachyspermum ammi), Pippali (Piper longum), and Haritaki (Terminalia chebula). A total of 40 subjects diagnosed with Functional Dyspepsia per Rome IV criteria and Vishtabdha Ajeerna, aged 18–60 years, will be selected and randomly allocated into two groups of 20 each. The intervention group will receive Induppukaanam Churna (6 g twice daily before food with warm water), while the control group will receive Pantoprazole 40 mg once daily before food with water, for a duration of 14 days (with 30-day follow-up). Clinical assessment will be carried out using Severity of Dyspepsia Assessment (SODA) and WHO scoring for Ayurvedic symptoms of Vishtabdha Ajeerna at baseline, day 15, and day 30, while quality of life will be evaluated as a secondary measure. The primary objective is to compare the efficacy of Induppukaanam Churna against Pantoprazole in symptom relief; statistical analysis will be performed using repeated measures ANOVA, Friedman test, and Kruskal-Wallis test. Data will be collected in prepared case report format. Data analysis with the use of Statestical Software.