Post Marketing study to evaluate the safety and efficacy of Glutazene sachetsSingle Arm Post Marketing Study to Evaluate Safety and Efficacy of Glutazene sachets in Adult Patients with ulcer

Single Arm Post Marketing Study to Evaluate Safety and Efficacy of Glutazene sachets ( Azulene and Glutamine) in Adult Patients with Symptomatic Acid Peptic Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/08/027039

Enrollment

200

Registered

2020-08-08

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: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Azulene and Glutamine: Glutamine (Azulene-Glutamine) is an amino acid that affects the processes of growth and function of cells in the stomach and intestines. Glutamine (Azulene-Gluta

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with confirmed endoscopic results for acid peptic disease, exhibiting symptoms of gastritis, gastric ulcers, duodenal ulcers and GERD 2.Male or female patients Ë?18 years and Ë? 65 years of age 3.Patient on treatment with proton pump inhibitor (PPI) recently(not more than 7 days) or newly starting PPI as part of acid peptic ulcer treatment 4.No allergies to any of the ingredients of the study drug 5.Patient willing to sign informed consent and are willing to follow the protocols requirements

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of Glutazene sachetsTimepoint: Visit 1 (Screening on Day 0) Telephonic interview (Week 2) Visit 2 (End of study visit on Day 28)	—

Secondary

Measure	Time frame
To evaluate the therapeutic effect of Glutazene sachets(through changes in symptoms from the baseline) in relief of symptoms of acid peptic disease like gastric ulcer, duodenum ulcer, GERD and gastritis. Change in quality of life from baselineTimepoint: Visit 1 (Screening on Day 0) Visit 2 (End of study visit on Day 28)	—

Countries

India

Contacts

Public ContactMr Vairamuthu Ammaiyappam

iDD Research Solutions Pvt ltd

yogesh@iddresearch.com04423780116

Outcome results

None listed

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