Efficacy and Safety of Troxipide extended release tablet in patients with gastritis and /or gastric ulcer

A Multi-centric, Randomized clinical trial to compare the efficacy and safety of Troxipide ER 300 mg and Troxipide IR 100 mg in the treatment of gastritis and /or gastric ulcer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/07/002840

Enrollment

120

Registered

2012-07-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K25- Gastric ulcer Health Condition 2: K297- Gastritis, unspecified

Interventions

Intervention1: Troxipide ER 300mg: Troxipide 300 mg To be taken orally Once in a day for 28 days Control Intervention1: TRoxipide IR 100 mg: Troxipide 100 mg To be taken orally, Thrice in a day for 28

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients between 18-65 years of age. 2. Patients showing the presence of at least three subjective clinical symptoms of gastritis and/or gastric ulcer disease of mild to moderate severity (Refer page 15 for details on the clinical symptoms) 3. Patients willing to give written informed consent and willing to comply with trial protocol.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
â?¢ Proportion of patients achieving clinical symptom improvement at week 4 (four point score of at least 1 point lower than baseline score).Timepoint: 28 days	—

Secondary

Measure	Time frame
â?¢ Complete Clinical Resolution: Proportion of patients achieving a four point score of 1 at week 4Timepoint: 28 days;â?¢ Mean time for clinical symptom improvementTimepoint: 28 days;â?¢ Mean time for complete clinical resolutionTimepoint: 28 days;â?¢ Proportion of patients reporting favorable response to treatmentTimepoint: 28 days	—

Countries

India

Contacts

Public ContactDr Suresh Jain

Digestive Endoscopy Clinic & A Day Care Centre

scjdr@yahoo.com9822335381

Outcome results

None listed

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