Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

December 5, 2013 updated by: Hafiz Muhammad Asif

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Shifa ul mulk memorial hospital
      • Karachi, Pakistan
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pylorex plus
Pylorex plus consisting of medicinal plants.
Drug: Quadruple Allopathic therapy
Other Names:
  • Amoxicillin
  • Omeprazol
  • Metronodazole
  • TRITEC (ranitidine bismuth citrate)
Drug: Pylorex plus
ACTIVE_COMPARATOR: Quadruple therapy
Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)
Drug: Quadruple Allopathic therapy
Other Names:
  • Amoxicillin
  • Omeprazol
  • Metronodazole
  • TRITEC (ranitidine bismuth citrate)
Drug: Pylorex plus

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 1 month
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hafiz Muhammad Asif

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asif-HP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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