Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

NCT ID: NCT02004197

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pylorex plus

Pylorex plus consisting of medicinal plants.

Group Type EXPERIMENTAL

Quadruple Allopathic therapy

Intervention Type DRUG

Pylorex plus

Intervention Type DRUG

Quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Quadruple Allopathic therapy

Intervention Type DRUG

Pylorex plus

Intervention Type DRUG

Interventions

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Quadruple Allopathic therapy

Intervention Type DRUG

Pylorex plus

Intervention Type DRUG

Other Intervention Names

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Omeprazol Amoxicillin Metronodazole TRITEC (ranitidine bismuth citrate)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hafiz Muhammad Asif

OTHER

Sponsor Role lead

Responsible Party

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Hafiz Muhammad Asif

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Khan Usman Ghani, Ph. D

Role: STUDY_DIRECTOR

Hamdard University Karachi

Locations

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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

Site Status

Shifa Ul MUlk Memorial Hospital

Karachi, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Asif-HP-001

Identifier Type: -

Identifier Source: org_study_id