Helicobacter Pylori [H. Pylori] as the Cause of Diseases
Conditions
Brief summary
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.
Interventions
DRUGQuadruple Allopathic therapy
DRUGPylorex plus
Sponsors
Hafiz Muhammad Asif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores | 1 month |
Countries
Pakistan
Outcome results
None listed