RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.
OBJECTIVE To compare the efficacy of Vonoprazan based dual treatment versus PPI based treatment for the eradication of Helicobacter pylori infection. OPERATIONAL DEFINITION Helicobacter Pylori infection: Hp infection will be labelled by any one of following investigation: * Helicobacter Pylori Stool Antigen * Histopathology on Giemsa Stain MATERIAL AND METHODS: Study Design: Randomized control trial. Setting: This study will be conducted in the Medical OPD and Medical Unit 1 of Dr. Ruth K.M. Pfau, Civil Hospital Karachi affiliated with Dow University of Health Sciences DATA COLLECTION PROCEDURE: All patients presenting to the OPD or Medical Unit 1 of Dr. Ruth KM Pfau, Civil Hospital Karachi and fulfilling the inclusion criteria will be included after taking informed consent. The participants will be randomly allocated to 2 groups with help of random number table and will be treated for 2 weeks. Group A: will be given: Capsule Amoxicillin 1 gm twice daily Tablet Clarithromycin 500 mg twice a day Capsule Omeprazole 20 mg twice a day Group B will be given: Capsule Amoxicillin 1 gm twice daily Tablet Vonoprazan 20 mg twice a day Confirmation of Hp eradication will be done by stool Hp antigen test 4 weeks after completion of treatment. DATA ANALYSIS Data will be stratified according to age \& gender. Frequency of gender \& mean (SD) of age will be compared between groups using Pearson's Chi-square test and Student's t-test respectively. Frequency of Hp eradication between two groups will be compared using Pearson's chi-square test. A p value \< .05 will be taken as significant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
Orally twice daily for 2 weeks
Orally twice daily for 2 weeks
Dr Ruth KM Pfau Civil Hospital Karachi
Karachi, Sindh, Pakistan
Helicobacter Pylori Eradication
Stool Heliobacter Pylori Antigen = Negative
Time frame: 4 weeks
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