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

Two hundred patients with Symptomatic Acid Peptic Disease selected from OPD of the designated hospitals (sites) will be included in this multi-center, single arm study. Patients will complete a screening visit (V1) to determine eligibility for the study based on Inclusion & Exclusion Criteria, patient history and safety measures.The duration of each patient’s participation in the study will be of 4 weeks (28 days). Scheduled study visits will include:

• Visit 1 (Screening on Day 0)

• Telephonic interview (Week 2)

• Visit 2 (End of study visit on Day 28)

During Visit 1 (Screening), informed consent will be obtained before any study procedures take place. After patient has been consented, medical history will then be documented, including the concomitant medications. All patients will undergo the screening procedure by inclusion and exclusion criteria. Demography, physical examination will be recorded. Patients will be given to fill the questionnaire for the assessment of the symptoms of the disease. Subjective assessment of the quality of life assessment using EQ5D- 5Lwill be done. Patients will be given instructions for the next visit.

Patients will be contacted telephonically in Week 2. They will be asked about the adverse events or any other problem.

At Visit 2 (End of Study Visit), patients will visit the site on Day 28. Patients will be given to fill the questionnaire for the assessment of the symptoms of the disease. Subjective assessment of the quality of life assessment using EQ5D- 5Lwill be done.

DISCUSSIONAND OVERALL CONCLUSIONS

Theobjective of this single arm, multicentric study was to evaluate safety andefficacy of Glutazene sachets (containing Azulene 2 g and Glutamine Granules663.30 mg) in patients with Acid Peptic Disease. Two hundred patients thatincluded 176 male and 24 female patients of Acid peptic disease were enrolledin the study. All 200 patients completed the study and received full dose ofGlutazene sachets as an adjuvant therapy. Safety was the primary objective ofthe study. Safety analysis was done on safety population. There were noalarming safety issues observed during the study period. Though majority of theadverse events were having either ‘certain’ or ‘possible’ or ‘’probablerelationship with the study drug administered, all the AEs were mild in nature.Commonly reported adverse events were transient. Efficacy was the secondaryobjective of the study. Efficacy analysis was done on ITT population. At theend of 28 days of treatment with the study medication, promising results wereobserved in the end points analyzed. Statistically significant difference wasobserved in analysis of quality of life assessment of patients after 28 days oftreatment of oral Glutazene sachets. Encouraging results were exhibited bytreatment of oral Glutazene sachet in case of Acid peptic disease symptoms. Outof fifteen symptoms marked during both the visits, nine symptoms present beforethe start of the treatment disappeared after 4 weeks of treatment with thestudy medication, showing improvement of all patients. Remaining symptoms werenot shown by any of the patients at both the visits. Good results were observedin EQ5D- 5L questionnaire assessing health status of the patient before andafter the treatment. (Refer Section 11.4.1 for details) Based on statisticalanalysis of this trial data, we can conclude that Glutazene sachets exhibitimpressive efficacy along with acceptable safety. Overall, the incidence of TEAEsin this trial was consistent with the known safety profile of Glutazene Sachetsand did not reveal any new alarming safety signal for it.