| CTRI Number |
CTRI/2025/11/098194 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of AS Gel On patients suffering from Mild to Moderate
Constipation. |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, parallel study to evaluate the
efficacy and safety of AS Gel On patients suffering from Mild to Moderate
Constipation. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR02143-008 (1.0) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkatesh S |
| Designation |
Consultant Doctor |
| Affiliation |
Vagus Super Speciality Hospital Pvt.Ltd. |
| Address |
Department of General Medicine, Room No-4, 6-8,18th Cross,4th main,Malleswaram west.
Bangalore
KARNATAKA
560055
India |
| Phone |
9738226474 |
| Fax |
|
| Email |
venkateshsmysore7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhargav Bhongiri |
| Designation |
Head Medical Writer |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No.6,3rd Floor, second Main Road, sarvobhaogam Nagar, Arekere.
Bangalore
KARNATAKA
560076
India |
| Phone |
9000518175 |
| Fax |
|
| Email |
bhargav.b@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargav Bhongiri |
| Designation |
Head Medical Writer |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No.6,3rd Floor, second Main Road, sarvobhaogam Nagar, Arekere.
KARNATAKA
560076
India |
| Phone |
9000518175 |
| Fax |
|
| Email |
bhargav.b@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Vagus Super Specialty Hospital,No 6-8 18th Cross,4th main,Malleshwaram, Bangalore, Karnataka, India, 560055 |
|
|
Primary Sponsor
|
| Name |
PR Nine Co., Ltd. |
| Address |
6 Soi Wachiratham Sathit 51,Bang Chak, Phra Khanong,Bangkok 10260 ,Thailand |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Saklecha |
Santosh Hospital |
6/1 3f, No 6/1, Near Coals Park, Promenade Road, Pulikeshi Nagar, Frazer Town- 560005
Bangalore
KARNATAKA |
9014308214
ssaklecha@gmail.com |
| Dr Venkatesh S |
Vagus Super Speciality Hospital Pvt.Ltd |
Department of General Medicine, Room No-4, 6-8,18th Cross,4th main,Malleswaram west.
Bangalore
KARNATAKA |
81519 94080
venkateshsmysore7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Santosh Hospital-Institutional Ethics Committee |
Submittted/Under Review |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AS GEL
|
Test product: AS GEL ,
Dose: 15 grams of AS gel daily ,
Dosage form: Gel ,
Frequency: Once daily 30 mins. after a meal for 8 weeks,
Route of administration: Oral
|
| Comparator Agent |
Placebo |
Test product: Placebo,
Dose: 15 grams of glycerin gel daily, Dosage form: Gel, Frequency: Once daily 30 mins. after a meal for 8 weeks, Route of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female individuals age from 18-60 (both inclusive).
2. Subjects suffering from mild to moderate constipation from last two weeks.
3. Subjects who have less than 3 bowel movements per week for at least 2 weeks
4. Subjects who agree to maintain their usual level of activity throughout the trial period
5. Those who voluntarily agree to participate and signs the informed consent form
6. Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for
the required treatment period visits, comply with therapy prohibitions,
and be able to complete the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and breastfeeding subjects have undergone any surgery and have taken part in any clinical Trial.
2. Significant history or presence of gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of common medications
3. Not willing to sign the ICF or give the consent.
4. Having hypersensitivity or history of allergy to the study product.
5. Suffering from a metabolic disorder
6. Subjects diagnosed with functional constipation as per Rome III criteria
7. Major gastrointestinal complication. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the efficacy and tolerability of the
test product.
2) Constipation Scoring System (CSS)
3) Score of Abdominal Pain |
Baseline, Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of the test product. |
Baseline, Week 4 |
| Number of spontaneous bowel movements (SBM) during week 1 (study days 1-7). |
Baseline, Week 4 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double-blind, placebo-controlled, parallel study designed to evaluate the efficacy and safety of AS Gel in patients with mild to moderate constipation. The study will assess improvements in Constipation Scoring System (CSS) scores and abdominal pain as primary endpoints, along with the number of spontaneous bowel movements and overall safety and tolerability as secondary endpoints. The study aims to determine whether AS Gel is a safe and effective treatment for relieving constipation symptoms. |