Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

Hafiz Muhammad Asif

Status and phase: Completed; Phase 3; Phase 2

Conditions: Helicobacter Pylori [H. Pylori] as the Cause of Diseases

Treatments: Drug: Quadruple Allopathic therapy; Drug: Pylorex plus

Study type: Interventional

Funder types: Other

Identifiers

NCT02004197

Asif-HP-001

Details and patient eligibility

About

Helicobacter pylori is strongly associated to the development of gastrointestinal disorders. Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted in significant eradication failure. Clinical trial was conducted to see the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H. pylori infection and relief in its associated symptoms in Pakistan.

Enrollment: 176 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The patients suffering from H. pylori infection
2. Patients having no previous record of treatment against H. pylori infection
3. Patients living in Karachi, Rawalpindi and Bahawalpur
4. Patients having no pathological complications on routine examination
5. All socioeconomic classes were included in the study
6. Male and female patients between 15 to 45 years of age

Exclusion criteria

1. there was peptic ulceration, gastrointestinal bleeding or gastric carcinoma
2. if history of use of antibiotics, proton-pump inhibitors or bismuth compound in the last one month before test
3. any patient found to be allergic or intolerant to therapeutic regimens
4. they failed to report for follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Pylorex plus

Experimental group

Description:

Pylorex plus consisting of medicinal plants.

Treatment:

Drug: Pylorex plus

Drug: Quadruple Allopathic therapy

Quadruple therapy

Active Comparator group

Description:

Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)

Treatment:

Drug: Pylorex plus

Drug: Quadruple Allopathic therapy