A Single Centric, Open-Label, Non-Randomized Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Petsaffa Tablets in Subjects Suffering From Constipation, Gas and Acidity

  • Shreya Verma Divisa Herbals Pvt. Ltd. E4E-E4J, 4th Floor, Block-B, Plot No.-70, Godrej Eternia, Industrial Area, Phase 1, Chandigarh, India.
  • Amrish Verma Divisa Herbals Pvt. Ltd. E4E-E4J, 4th Floor, Block-B, Plot No.-70, Godrej Eternia, Industrial Area, Phase 1, Chandigarh, India.
  • Jaspal Singh Divisa Herbals Pvt. Ltd. E4E-E4J, 4th Floor, Block-B, Plot No.-70, Godrej Eternia, Industrial Area, Phase 1, Chandigarh, India.
  • Hasan Ali Ahmed Xplora Clinical Research Services Pvt. Ltd., Bangalore, Karnataka.
  • Dilip Kadam Care Multispecialty Hospital, Pune, Maharashtra, India.
Keywords: Petsaffa tablet, Functional constipation, Bowel movement, Clinical study.

Abstract

Constipation, gas, and acidity are common gastrointestinal issues with a significant global prevalence. Traditional medicine systems like Ayurveda have long utilized medicinal plants to address these concerns. However, clinical validation of their efficacy in patients with constipation has been lacking. Objectives: This study aimed to assess the efficacy and safety of Petsaffa tablets, an Ayurvedic formulation containing various herbal ingredients, in relieving constipation, gas, and acidity. Methods: The study, conducted as a single-centric, open-label, non-randomized post-marketing surveillance study, involved 120 subjects with constipation. Subjects were evaluated using inclusion and exclusion criteria and provided Petsaffa tablets for a 14-day intervention. Various parameters, including bowel movement frequency, constipation scores, and subjective assessments, were measured. Vital signs, laboratory safety parameters, and adverse events were also monitored during the study period. Results: Petsaffa tablets significantly improved bowel movement frequency, constipation scores, and subjective symptoms related to constipation. Stool consistency and other associated symptoms such as acidity and gas were also reduced at the end of the study. None of the participants reported any adverse events, and safety parameters remained within normal limits during the study period. Conclusion: Petsaffa tablets offer a promising, safe, and effective alternative option for individuals with common gastrointestinal issues such as constipation, acidity, and gas.

Published
04-05-2024
How to Cite
Shreya Verma, Amrish Verma, Jaspal Singh, Hasan Ali Ahmed, & Dilip Kadam. (2024). A Single Centric, Open-Label, Non-Randomized Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Petsaffa Tablets in Subjects Suffering From Constipation, Gas and Acidity. International Journal of Ayurveda and Pharma Research, 12(4), 42-50. https://doi.org/10.47070/ijapr.v12i4.3207
Section
Articles