A Comparative Clinical trial to Evaluate the Efficacy and Tolerability of Troxipide in the treatment of gastritis and/or gastric ulcer disease.

A parallel, randomized, comparative, double-blind, double-dummy clinical trial to evaluate the efficacy and safety of Troxipide versus Rabeprazole in the Treatment of Gastritis & Gastric Ulcer

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/12/003264

Enrollment

Registered

2012-12-27

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: K290- Acute gastritis Health Condition 2: K294- Chronic atrophic gastritis

Interventions

Intervention1: Troxipide: 100 mg t.i.d orally for 28 days Control Intervention1: Rabeprazole: 20 mg o.d orally for 28 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18 years or older. 2. Clinical symptoms and endoscopic diagnosis of gastric mucosal injury (erosion/ oozing/redness/edema) as in gastritis (acute or acute exacerbation of chronic gastritis) and/or gastric ulcers (Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification). 3. Patients willing to give written informed consent and willing to comply with trial protocol. 4. Patients who are on therapy with PPI, H2RAs, NSAIDs, muscarinic antagonists or other gastroprotective agents, but who have undergone a washout period of 7 days wherein only oral antacids are taken.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Proportion of patients showing improvement in Visual Analog Scale (VAS) symptom severity scores (patients with â?¥ 50% improvement in baseline symptom severity), Resolution of clinical Symptoms: Proportion of patients reporting a maximal allowable score of 20 on the VAS Scale for the clinical symptoms evaluated, Degree of ulcer healing: Proportion of patients reporting a change in the ulcer stage as per the Sakita-Miwa classification of gastric ulcers based on the endoscopic examinations.Timepoint: 4 weeks (28 days)	—

Measure

Time frame

Proportion of patients showing improvement in Visual Analog Scale (VAS) symptom severity scores (patients with â?¥ 50% improvement in baseline symptom severity), Resolution of clinical Symptoms: Proportion of patients reporting a maximal allowable score of 20 on the VAS Scale for the clinical symptoms evaluated, Degree of ulcer healing: Proportion of patients reporting a change in the ulcer stage as per the Sakita-Miwa classification of gastric ulcers based on the endoscopic examinations.Timepoint: 4 weeks (28 days)

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Secondary

Measure	Time frame
Cure of gastric ulcer: Defined as â??Scarring Stageâ?? as per the Sakita-Miwa classification of gastric ulcers based on the endoscopic examinations.Timepoint: 4 weeks (28 days);Cure of gastritis and/or gastric ulcers: Defined as a score of 1 for Erosions and the absence of Oozing, Redness and Edema based on the endoscopic examinations.Timepoint: 4 weeks (28 days);Patient and Investigator assessment of efficacy and tolerance at the end of the treatment.Timepoint: 4 weeks (28 days);Sustained clinical symptom relief: Defined as the absence of the clinical symptom evaluated in the previous 7 days, (i.e. no clinical symptom in the previous week) with a score of 0 on the VAS Scale.Timepoint: 4 weeks (28 days)	—

Measure

Time frame

Cure of gastric ulcer: Defined as â??Scarring Stageâ?? as per the Sakita-Miwa classification of gastric ulcers based on the endoscopic examinations.Timepoint: 4 weeks (28 days);Cure of gastritis and/or gastric ulcers: Defined as a score of 1 for Erosions and the absence of Oozing, Redness and Edema based on the endoscopic examinations.Timepoint: 4 weeks (28 days);Patient and Investigator assessment of efficacy and tolerance at the end of the treatment.Timepoint: 4 weeks (28 days);Sustained clinical symptom relief: Defined as the absence of the clinical symptom evaluated in the previous 7 days, (i.e. no clinical symptom in the previous week) with a score of 0 on the VAS Scale.Timepoint: 4 weeks (28 days)

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Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Ltd.

bhupesh.dewan@zuventus.com

Outcome results

None listed

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