Abstract

CLINICAL STUDY ON THE SAFETY AND EFFICACY OF GUT RESET CAPSULES IN ALLEVIATING THE GASTRO-ESOPHAGEAL REFLUX (GER)

Shubhangi Mehra*, Sugam Saraswat, Gaurav Paliwal and Meena Dalal

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Abstract

Background: Glabridin, a major flavonoid, displayed anti-ulcer and anti-inflammatory activity, which is beneficial in restoring normal physiological functioning of the stomach and reducing GER symptoms. Methods: A randomized double-blind, placebo-controlled trial was conducted with 50 patients aged 18-60 years to evaluate the safety and efficacy of Capsules in reducing gastro-esophageal reflux (GER)- related symptoms (GUT RESET-25 subjects, Placebo-25 subjects). Results: For 60-day trial durations, while evaluating on Days 15, 30, 45 and 60, study outcomes efficacy of GUT RESET Capsules in the severity of gastroesophageal symptoms such as burning in the chest, backwash (regurgitation) of food or sour liquid, upper abdominal or chest pain, difficulty swallowing (dysphagia), a lump in your throat, an ongoing cough, and vocal cord inflammation (laryngitis).It was safe to use laboratory parameters- LFT, RFT, CBC and other adverse events to evaluate quality of life. Conclusion: This study reveals that GUT RESET Capsules had a substantial effect on reducing the intensity and frequency of GER symptoms measured by the GSAS scale during a 60-day period. The safety evaluation reaffirms GUT RESET Capsules favorable safety profile, with no adverse events and key laboratory and vital sign values remaining within acceptable levels. As a result, studies should have well-defined goals and clinical efficacy.

Keywords: Clinical study, Glabridin, Symptoms, GER.