jrnls.org logo
Submit

BROWSE ALL JOURNALS

SEE ALL 19 JOURNALS
International Journal of Pharmaceutical InvestigationNOW IN
Article

Evaluation of efficacy and safety of Ayucid capsule in subjects suffering from chronic symptomatic gastroesophageal reflux disease

Sanjay M. Tamoli1★, Shishir P. Pande2, Shailesh V. Deshpande3, Narendra B. Mundhe4, Mandar V. Doiphode3, Ganesh S. Kolhe4, Sachin A. Upasani1★ Corresponding author

  1. 1Department of Medical Research, Target Institute of Medical Education and Research, Mumbai.
  2. 2Department of Rasashastra and Bhaishajya Kalpana, Ayurveda Research Centre, Ayurved Seva Sangh, Nashik.
  3. 3Department of Kayachikitsa, PDEA’s College of Ayurveda and Research Centre, Pune.
  4. 4Department of Kayachikitsa, KVTR Ayurvedic College, Boradi, Maharashtra, INDIA.

CORRESPONDENCE

Sanjay M. Tamoli

Department of Medical Research, Target Institute of Medical Education and Research, Mumbai.

sanjaytamoli@hotmail.com

Volume 8, Issue 2 · pp. 100–105 · PUBLISHED · DOI: 10.4103/jphi.JPHI_35_18

View on IJPI original site ↗

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

Open in new tab

REFERENCES

As published

Showing references and in-text citations exactly as published.

    Cite this article

    SELECT FORMAT

    Tamoli, S. M., Pande, S. P., Deshpande, S. V., Mundhe, N. B., Doiphode, M. V., Kolhe, G. S., & Upasani, S. A. (). Evaluation of efficacy and safety of Ayucid capsule in subjects suffering from chronic symptomatic gastroesophageal reflux disease. International Journal of Pharmaceutical Investigation, 8(2), 100–105. https://doi.org/10.4103/jphi.JPHI_35_18