A Clinical study to evaluate efficacy and safety of Ayulax Capsule in the Management of Functional Constipation

This study is an open labeled, non-comparative, prospective, single center, clinical study to evaluate safety and efficacy of Ayulax Capsule in the Management of Functional Constipation. Two Ayulax Capsules will be given at bed time orally with water for 14 days. After 14 days, subjects will be asked to stop taking medicine. Subjects will be asked to come for follow up on 21st day to see relapse/recurrence of symptoms of functional constipation. The primary objective of the trial is to evaluate efficacy of Ayulax Capsule in the Management of Functional Constipation by assessing changes in frequency of bowel movements. The secondary objectives of the trial are to evaluate changes in stool form (assessment using ‘Bristol stool form scale), Changes in symptoms of functional constipation [straining on defecation, sensation of incomplete evacuation, sensation of anorectal blockage, manual maneuvers required & average time spent for bowel evacuation], Changes in associated clinical symptoms, Global assessment for overall improvement by the physician, Global assessment for overall improvement by the Patient, tolerability of drug by the physician and by patient, adverse events/adverse drug reaction,  laboratory parameters. The study will be completed in 30 patients.

Summary of Results:

The objective of present study was to evaluate efficacy and safety of Ayulax capsule in the management of functional constipation. 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 of study showed significant increase in bowel frequency 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, however 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 and subsided normally. It can thus be concluded that Ayulax capsule acts as an effective and safe laxative in treatment of functional constipation.