Shridhar J Pandya¹, Chetan H Savaliya¹ and Dheeraj H Nagore²*

¹Research and Development, Gplife Healthcare Pvt Ltd, Surat, Gujarat, India

*Corresponding Author: Dheeraj H Nagore, Clinical Research, Mprex Healthcare Pvt Ltd, Wakad, Pune, Maharashtra, India.

Received: November 04, 2022; Published: November 23, 2022

Abstract

In the current scenario, people have often adopted a sedentary lifestyle with a large amount of fast-food consumption, a lack of a balanced and nutritious diet, etc., which is drastically hampering their gut health. So there is an emerging need for a promising and safe medication for gastrointestinal illnesses that promotes improvement of overall gut health. The present clinical trial aims at generating evidence around the safety and effectiveness of incorporating a phytoconstituents-based product in the management of digestive ailments. This clinical trial was a randomized, double-blind, placebo-controlled trial involving 60 patients with self-described gastrointestinal symptoms, divided equally into two parallel groups. Herbal formulation and placebo treatment were given as 1 tablet twice a day after meals for 3 months. Response to treatment was evaluated from the baseline to the end of the study on the basis of changes in symptom scores for various clinical symptoms like epigastric pain, heartburn, nausea, constipation, etc. Also, the safety and tolerability of the drug were evaluated by monitoring adverse events and hematological, lipid, liver, and renal function tests at baseline and the end of the study. 100% of patients got relief from symptoms like epigastric discomfort, belching, flatulence, fullness of the stomach, abdominal distension, hyperacidity, bloating, and postprandial fullness in 14 days of treatment with herbal formulation. 100% of patients got relief from heartburn, nausea, and vomiting in 7 days of treatment with herbal formulation. Also, 100% of patients got relief from constipation after 90 days of treatment of herbal formulation. There was reduction in rescue medication for 90% of subjects after 90 days of treatment of herbal formulation. While there was no evidence of fluctuation in liver function test, renal function test and lipid profile indicating systemic safety. Therefore, indicating improvement in overall health and quality of life of patients with gastrointestinal discomfort as compared to the placebo treatment.

Keywords: Gastrointestinal Symptoms; Gut Health; Herbal Formulation; Constipation; Quality of Life

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Citation

Citation: Shridhar J Pandya., et al. “Evaluation of the Safety and Efficacy of Herbal Formulation on Gastrointestinal Health - A Randomized, Double-Blind, Placebo-Controlled Study". Acta Scientific Gastrointestinal Disorders 5.12 (2022): 16-28.

Copyright

Copyright: © 2022 Shridhar J Pandya., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.