Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

Phase 3CompletedNCT02004197

Hafiz Muhammad Asif176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

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

Interventions

Quadruple Allopathic therapyDRUG

Pylorex plusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

clinical trial was conducted in high risk areas of Pakistan such as Karachi, Bahawalpur, Islamabad and Rawalpindi at Shifa-Ul-Mulk Memorial Hospital, Hamdrad University Karachi, Bahawalpur Victoria Hospital and Nawaz Salik Hospital respectively

Karachi, Pakistan

Shifa Ul MUlk Memorial Hospital

Karachi, Pakistan

Outcomes

Primary Outcomes

H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment

Time frame: 1 month

Secondary Outcomes

The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.