OPEN LABEL SINGLE CENTRIC CLINICAL EXPLORATORY OF EFFICACY STUDY ON DELIPO CAPSULE, AN AYURVEDIC PROPRIETARY FORMULATION

Introduction: Obesity and hypercholesterolemia are significant global health concerns, contributing to metabolic disorders such as cardiovascular disease and type 2 diabetes. Conventional treatments often include pharmacological interventions and lifestyle modifications, which may have limitations in terms of adherence and side effects. Ayurvedic medicine offers a holistic approach to weight management and metabolic regulation. DELIPO CAPSULE, a proprietary Ayurvedic formulation, has been developed to address symptoms associated with obesity, including shortness of breath, fatigue, excessive sweating,, difficulty in sleeping and high LDL cholesterol levels. Objective: The primary objective of this study was to evaluate the clinical efficacy of DELIPO CAPSULE in managing symptoms of obesity and hypercholesterolemia. Methods: The study aimed to assess its impact on weight management, cholesterol levels, and associated symptoms over a 30-day treatment period. This Phase-IIA, single-center, open-label, therapeutic exploratory clinical trial was conducted on 20 patients diagnosed with obesity-related conditions. Participants were administered 1-2 DELIPO CAPSULES twice daily with lukewarm water for 30 days. Clinical and laboratory assessments were performed at baseline (day-1) and post-treatment (day-30). Ethical approval was obtained, and written informed consent was secured from all participants. Results: After 30 days of treatment: 75% (15 patients) experienced significant symptom improvement. 15% (3 patients) showed moderate improvement. 5% (1 patient) had mild improvement. 5% (1 patient) dropped out of the study. Laboratory investigations confirmed improvements in cholesterol levels and metabolic markers. Conclusion: DELIPO CAPSULE demonstrated significant efficacy in managing obesity-related symptoms and metabolic imbalances. The findings support its potential as a safe and effective Ayurvedic intervention for weight management and hypercholesterolemia.