International Journal of Pharmaceutical Investigation, 2018, 8, 2, 100-105.
DOI: 10.4103/jphi.JPHI_35_18
Published: April 2018
Type: Original Article
Authors:
Sanjay M. Tamoli
Department of Medical Research, Target Institute of Medical Education and Research, Mumbai, Maharashtra, India.
Shishir P. Pande
Department of Rasashastra and Bhaishajya Kalpana, Ayurveda Research Centre, Ayurved Seva Sangh, Nashik, Maharashtra, India.
Shailesh V. Deshpande
Department of Kayachikitsa, PDEA’s College of Ayurveda and Research Centre, Pune, Maharashtra, India.
Narendra B. Mundhe
Department of Kayachikitsa, KVTR Ayurvedic College, Boradi, Maharashtra, India.
Mandar V. Doiphode
Department of Kayachikitsa, PDEA’s College of Ayurveda and Research Centre, Pune, Maharashtra, India.
Ganesh S. Kolhe
Department of Kayachikitsa, KVTR Ayurvedic College, Boradi, Maharashtra, India.
Sachin A. Upasani
Department of Medical Research, Target Institute of Medical Education and Research, Mumbai, Maharashtra, India.
ABSTRACT
Objectives: The objective of the study was to assess the efficacy and safety of Ayucid capsule and Omeprazole 20 mg in patients suffering from chronic symptomatic gastroesophageal reflux disease (GERD). Materials and Methods: It was an open‑label, randomized, comparative, multicenter, prospective clinical study. Subjects in Ayucid group were advised to consume two Ayucid capsules twice daily orally before meals, and subjects in Omeprazole group were advised to consume one Omeprazole (20 mg) capsule orally before lunch for 28 days. All P values were reported based on two‑sided significance test, and all the statistical tests were interpreted at 5% level of significance. Results: A total of 63 subjects (33 in Ayucid group and 30 in Omeprazole group) completed the study. At the end of the study, the number of cases of heartburn and symptom of heartburn and severity scores of acid regurgitation, dysphasia, and nausea reduced significantly (P < 0.05) in both the study groups. Significant relief in symptoms such as epigastric pain, loss of appetite, bloating of stomach, constipation, and gaseous distension was observed in both the groups. Majority of subjects showed significant (P < 0.05) reduction in GERD health‑related quality of life subscores and improvement in overall efficacy in both the groups. No posttreatment significant (P > 0.05) changes were observed in safety laboratory parameters and vitals. Of the reported adverse events in the two groups, none were found to be related to the study drugs. Conclusion: Ayucid capsule is equally effective or noninferior to that of Omeprazole capsule in relieving the GERD symptoms.
Keywords: Ayucid capsule, Gastroesophageal reflux disease, Health‑related quality of life subscore, Omeprazole capsule.