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

Background of the study: Gastrointestinal disorders such as Amlapittha (GERD), Ajeerana (indigestion), Agnimandya (loss of appetite), Gulma (peptic ulcer), and Kroorakoshta (bowel disturbances) are prevalent health concerns. Traditional Ayurvedic medicine offers natural therapeutic solutions for digestive health. The present study clinically validates the efficacy of Fruit Fiber Capsule, a proprietary Ayurvedic formulation, in managing these conditions. The primary objective of this Phase-II-A, single-center, open-label, therapeutic exploratory clinical trial was to evaluate the effectiveness of Fruit Fiber Capsule in relieving gastrointestinal symptoms and improving digestive health. Methods: A total of 20 patients suffering from digestive disorders were enrolled in this study following ethical clearance. Patients were administered 1-2 capsules twice daily with lukewarm water for 30 days. Clinical investigations and laboratory assessments were conducted on Day 1 (Baseline) and Day 30 (End of Trial) by qualified AYUSH practitioners. Patients' symptoms, including epigastric pain, halitosis, bloating, fatigue, and abdominal discomfort, were monitored throughout the trial. Results: After 30 days of treatment, 75% (15 patients) showed very good improvement, 15% (3 patients) exhibited moderate improvement, 5% (1 patient) had mild improvement, and 5% (1 patient) reported no significant relief. One participant dropped out. The results indicate that Fruit Fiber Capsule significantly alleviated digestive disorders and enhanced overall gastrointestinal health. Conclusion: The study confirms that Fruit Fiber Capsule is an effective Ayurvedic intervention for digestive disorders, showing promising outcomes in GERD, indigestion, and bowel disturbances. Further large-scale studies are recommended for broader validation.