OPEN-ACCESS PEER-REVIEWED
1Soumik Banerjee, 2Gitanjali Talele, 3Sudipta Narayan Roy
1Soumik Banerjee, Ph.D. (Science), Department of Biotechnology, Brainware University, Kolkata, West Bengal, India.
2Gitanjali Talele, PGDM, Pharmacy Graduate, Department of Medical Writing, Clinica Research Solutions LLP, Belapur, Navi Mumbai, India
3Dr. Sudipta Narayan Roy, BHMS (Cal), FWT (Cal), SMEP (IIM,A), DipHomoeo (Germany), DipOnco (UK), Managing Director & Group CEO Powell Laboratories (P) Limited GN 28, Sector- V, Salt Lake City, Kolkata – 700091, West Bengal, India.
Abstract
Introduction: Gastritis is a condition with variable clinical manifestations and no known cure. An NSAID-based treatment for Helicobacter pylori infection has been associated with negative side effects conventionally. Studies have been done on the potential of investigational medicinal products (IMPs) to cure gastritis. In this study, the efficacy of the IMPs was compared against placebos in the treatment of gastritis.
Methods: A randomised, double-blind, placebo-controlled investigation was conducted in the region of Maharashtra, India. In addition to standard medication, patients were administered either investigational medicinal products (IMPs) or placebos. The primary and secondary outcomes were assessed using the Gastrointestinal Quality of Life Index (GIQLI) and the Visual Analogue Scale Severity Scale for Pain (VAS), respectively. Measurements were taken at the initial assessment and subsequently on a weekly basis for a duration of four weeks. The sample that was intended-to-treat (ITT) was analysed using a two-way repeated measures ANOVA.
Results: There were 60 participants in the analysis. By the conclusion of week four, the Gastroplex®-treated participants had significantly less pain than the placebo group (p-value = 0.003). With a significant effect size, the GIQLI score likewise favored IMPs over placebos (p-value = 0.002). There were no negative consequences noted.
Conclusion: Gastroplex® demonstrated better efficacy compared to placebo in lowering pain and raising GIQLI scores in participants with acute and chronic gastritis. The therapy was also safe and well-tolerated.
Trial registration: CTRI/2023/01/049226
Keywords: Gastritis, Gastroplex®, randomized controlled trials, Helicobacter pylori, placebo
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