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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/01/005349
• Date of registration: 05-01-2015
• Prospective Registration: No
• Primary sponsor: Welex Laboratories Pvt Ltd
• Public title: A Clinical trial to study effect of Ayulax Capsule in the Management of Functional Constipation
• Scientific title: A Clinical study to evaluate efficacy and safety of Ayulax Capsule in the Management of Functional Constipation - NIL
• Date of first enrolment: 08-12-2014
• Target sample size: 36
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10634
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 3/ Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Sanjay Tamoli
• Affiliation: Target Institute of Medical Education and Research

• Name: Dr Sanjay Tamoli
• Affiliation: Target Institute of Medical Education and Research

Key inclusion & exclusion criteria

Inclusion criteria: 1. 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: 1. Subjects with diagnosed colonic inertia.

2. Subjects who have recently undergone abdominal surgery

3. Subjects with history of anorectal surgery.

4. 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.

6. Subjects with renal or liver dysfunction

7. Pregnant or lactating females









8. Subjects with disturbed thyroid functions



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Functional Constipation

Intervention(s)

Intervention1: Ayulax Capsule: Each Capsule Contains Sanai Patra (Cassia angustifolia), Trivruta (Operculina turpethum) , Haritaki (Terminalia chebula), Yavani (Trachyspermum ammi), Shatapushpa (Pimpinella anisum), Shunthi (Zingiber officinale), Murud Shenga (Helicteres isora), Yastimadhu (Glycyrrhiza glabra), Amalaki (Emblica officinalis) Dosage:
2 capsules at bed time orally with water for 14 days.

Control Intervention1: NIL: NIL

Primary Outcome(s)

To evaluate efficacy of Ayulax Capsule in the Management of Functional Constipation by assessing changes in frequency of bowel movementsTimepoint: 14 days and 21 days

Secondary Outcome(s)

1. Changes in stool form

2. Changes in symptoms of functional constipation

3. Changes in associated clinical symptoms

4. Global assessment for overall improvement by the physician

5. Global assessment for overall improvement by the Patient

6. Tolerability of drug by the physician and by patient

7. Adverse events

8. Laboratory parameters

Timepoint: 14 days and 21 days

Secondary ID(s)

ALWL13/FC/01/2013, Version 0, 18th December 2013

Source(s) of Monetary Support

Welex Laboratories Pvt. Ltd. 120, T.V. Industrial Estate, 248/A, S.K. Ahire Marg, Worli, Mumbai-400 025

Ethics review

Status: Approved
Approval date: 11/10/2014
Contact:

Institutional Ethics Committee, R. A. Podar Medical College (Ayurvedic) and M. A. Podar Hospital