Back to resultsQuadruple and Phytomedicine-based Therapies in H. Pylori Infection
Primary Purpose
Helicobacter Pylori [H. Pylori] as the Cause of Diseases
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Quadruple Allopathic therapy
Pylorex plus
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori [H. Pylori] as the Cause of Diseases
Eligibility Criteria
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
Sites / Locations
- 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
- Shifa Ul MUlk Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pylorex plus
Quadruple therapy
Arm Description
Pylorex plus consisting of medicinal plants.
Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02004197
Brief Title
Quadruple and Phytomedicine-based Therapies in H. Pylori Infection
Official Title
Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hafiz Muhammad Asif
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori [H. Pylori] as the Cause of Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pylorex plus
Arm Type
Experimental
Arm Description
Pylorex plus consisting of medicinal plants.
Arm Title
Quadruple therapy
Arm Type
Active Comparator
Arm Description
Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)
Intervention Type
Drug
Intervention Name(s)
Quadruple Allopathic therapy
Other Intervention Name(s)
Omeprazol, Amoxicillin, Metronodazole, TRITEC (ranitidine bismuth citrate)
Intervention Type
Drug
Intervention Name(s)
Pylorex plus
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khan Usman Ghani, Ph. D
Organizational Affiliation
Hamdard University Karachi
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Karachi
Country
Pakistan
Facility Name
Shifa Ul MUlk Memorial Hospital
City
Karachi
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Quadruple and Phytomedicine-based Therapies in H. Pylori Infection
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