A CLINICAL STUDY TO EVALUATE EFFICACY AND SAFETY OF AYULAX CAPSULE IN THE MANAGEMENT OF FUNCTIONAL CONSTIPATION

Dr. C. D. Jagdhane, Dr. Monica Shrestha, Dr. Sanjay Tamoli*

ABSTRACT

Objectives: The objective of present study was to evaluate efficacy and safety of Ayulax capsule in the management of functional constipation. Methods: Total 34 subjects suffering from functional constipation were recruited in the study. All subjects were given Ayulax capsule in a dose of 2 capsules at bed time orally with water for 14 days. After baseline visit (day 0), all subjects were called for follow-up visits on day 7, 14 and 21. Patients were advised to stop taking Ayulax capsule from day 14 to day 21 to observe recurrence. Data describing quantitative measures were expressed as mean + SD. Comparison of variables representing categorical data was performed using appropriate statistical methods. Results: Significant increase in bowel frequency was observed at the end of the study as compared to baseline visit. Statistically significant changes in stool form (on Bristol scale) were observed at the end of the study. Also, significant decrease in mean score of straining on defecation, sensation of anorectal blockage (on VAS), requirement of manual assistance to evacuate, time spent for bowel evacuation and other associated symptoms of constipation were observed at the end of study. There was slight increase in score of associated symptoms of constipation after observatory period. But the score of associated symptoms was less than that of baseline value. Most of the subjects showed excellent to good overall efficacy and tolerability to study drug. Very few patients had mild abdominal cramps which did not require any treatment. Conclusion: Ayulax capsule acts as an effective and safe laxative in treatment of functional constipation.

Keywords: Ayulax capsule, Functional constipation, Bristol scale, VAS.