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Efficacy and safety of AS Gel On patients suffering from Mild to Moderate Constipation.

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. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098194
Enrollment
50
Registered
2025-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: 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 Control Inte

Sponsors

PR Nine Co., Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1) To evaluate the efficacy and tolerability of the test product. 2) Constipation Scoring System (CSS) 3) Score of Abdominal PainTimepoint: Baseline, Week 4—

Secondary

MeasureTime frame
To evaluate the safety of the test product.Timepoint: Baseline, Week 4;Number of spontaneous bowel movements (SBM) during week 1 (study days 1-7).Timepoint: Baseline, Week 4—

Countries

India

Contacts

Public ContactDr Bhargav Bhongiri

Syncorp Health Pvt. Ltd.

bhargav.b@syncorphealth.com9000518175

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026