Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

Study Overview
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Brief Summary
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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.

Official Title
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Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial

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

Intervention / Treatment
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* Drug: Quadruple Allopathic therapy
* Drug: Pylorex plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients suffering from H. pylori infection Patients having no previous record of treatment against H. pylori infection Patients living in Karachi, Rawalpindi and Bahawalpur Patients having no pathological complications on routine examination All socioeconomic classes were included in the study Male and female patients between 15 to 45 years of age Exclusion Criteria: there was peptic ulceration, gastrointestinal bleeding or gastric carcinoma if history of use of antibiotics, proton-pump inhibitors or bismuth compound in the last one month before test any patient found to be allergic or intolerant to therapeutic regimens they failed to report for follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pylorex plus<br>Pylorex plus consisting of medicinal plants. | Drug: Quadruple Allopathic therapy<br> <br> * Other names: TRITEC (ranitidine bismuth citrate);Drug: Pylorex plus<br> <br> |
| Active Comparator: Quadruple therapy<br>Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate) | Drug: Quadruple Allopathic therapy<br> <br> * Other names: TRITEC (ranitidine bismuth citrate);Drug: Pylorex plus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores |  | 1 month |