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Quadruple and Phytomedicine-based Therapies in H. Pylori Infection

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ClinicalTrials.gov Identifier: NCT02004197
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital

Tracking Information
First Submitted Date  ICMJE August 20, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date December 9, 2013
Study Start Date  ICMJE January 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quadruple and Phytomedicine-based Therapies in H. Pylori Infection
Official Title  ICMJE Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori [H. Pylori] as the Cause of Diseases
Intervention  ICMJE
  • Drug: Quadruple Allopathic therapy
    Other Names:
    • Omeprazol
    • Amoxicillin
    • Metronodazole
    • TRITEC (ranitidine bismuth citrate)
  • Drug: Pylorex plus
Study Arms  ICMJE
  • Experimental: Pylorex plus
    Pylorex plus consisting of medicinal plants.
    Interventions:
    • Drug: Quadruple Allopathic therapy
    • Drug: Pylorex plus
  • Active Comparator: Quadruple therapy
    Omeprazole, Amoxicillin, Metronodazole and TRITEC (ranitidine bismuth citrate)
    Interventions:
    • Drug: Quadruple Allopathic therapy
    • Drug: Pylorex plus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2013)
176
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004197
Other Study ID Numbers  ICMJE Asif-HP-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital
Study Sponsor  ICMJE Hafiz Muhammad Asif
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Khan Usman Ghani, Ph. D Hamdard University Karachi
PRS Account Shifa Ul Mulk Memorial Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP