A Clinical trial to study effect of Ayulax Capsule in the Management of Functional Constipation

Phase 3

Completed

Conditions: Functional Constipation

Registration Number: CTRI/2015/01/005349

Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary: 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 â€˜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.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis a.
Straining during at least 25 percent of defecations b.
Lumpy or hard stools at least 25 percent of defecations c.
Sensation of incomplete evacuation at least 25 percent of defecations d.
Sensation of anorectal blockage at least 25 percent of defecations e.
Manual maneuvers to facilitate at least 25 percent of defecations f.
Fewer than three defecations per week 2.
Subjects having stool form between 1 to 3 on the Bristol Stool Form Scale.

Exclusion Criteria

Subjects with diagnosed colonic inertia.
Subjects who have recently undergone abdominal surgery 3.
Subjects with history of anorectal surgery.
Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e. IBS, Belching disorders etc.) 5.
Subjects with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis.
Pregnant or lactating females 8.
Subjects with disturbed thyroid functions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy of Ayulax Capsule in the Management of Functional Constipation by assessing changes in frequency of bowel movements	14 days and 21 days

Secondary Outcome Measures

Name	Time	Method
1. Changes in stool form	2. Changes in symptoms of functional constipation

Trial Locations

Locations (1): Shalyatantra Dept, R. A. Podar Ayurved Medical College and M. A. Podar Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Shalyatantra Dept, R. A. Podar Ayurved Medical College and M. A. Podar Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr C D Jagdhane
Principal investigator
9819968385
cjagdhane@gmail.com