A CLINICAL STUDY TO EVALUATE EFFICACY AND SAFETY OF PILOSET TABLET + PILOSET CREAM IN PATIENTS SUFFERING FROM INTERNAL HEMORRHOIDS

Nandkishor Borse, Sangram Indore, Rashmi Bhise, *Arjun K. Kohli and Sanjay N. Tamoli

ABSTRACT

Objectives: The main objective of study was to assess the efficacy and safety of Piloset tablet + Piloset cream (polyherbal formulations) in subjects suffering from internal hemorrhoids. Methods: It was an open label, single-center, prospective, interventional, phase II clinical trial. Total 32 subjects were completed the study. All subjects were advised to take two Piloset tablets twice daily orally after meals and to apply sufficient amount of Piloset cream on piles mass twice daily for 60 days. After baseline visit, all subjects were called for follow-up on day 15, 30, 45 and day 60. Data describing quantitative measures were expressed as mean + SD. Comparison of variables representing categorical data was performed using Chi-square test or Fisher’s exact test. Results: Episodes of bleeding per rectum were completely stopped in all 32 patients. At the end of the treatment, a significant reduction in abdominal pain & discomfort, straining on defecation, mucus discharge, pain at anal region (assessed on VAS scale) and pruritus has been observed. No significant change in vital parameters and safety laboratory parameters were observed at the end of the study. Global evaluation by the physician and patient showed excellent improvement in the symptoms of hemorrhoids. Almost all patients showed excellent tolerability to the study drugs. Conclusion: The study provides good evidence in support of the efficacy and safety of Piloset tablet + Piloset cream in hemorrhoids.

Keywords: Piloset tablet + Piloset cream, hemorrhoids, VAS.