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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2014070118310N1
Date of registration: 2014-09-10
Prospective Registration: No
Primary sponsor: Vice Chancellor for researchesand Technology, Ilam University of Medical Sciences
Public title: The antioxidant effects of Q10 co enzyme on oxidative stress and lipid per oxidation among gastric patients infected by h.pylori
Scientific title: Anti oxidant properties of Q10 co enzyme and their effects on oxidative stress and lipid per oxidation among patients infected by h. pylori
Date of first enrolment: 2014-06-22
Target sample size: 100
Recruitment status: Complete
URL:  http://en.irct.ir/trial/16638
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Dr Asadollahi Khairollah   
Address:  Dept. Epidemiology, Banganjab, Faculty of Medicine, Ilam University of Medical Scences Ilam Iran (Islamic Republic of)
Telephone: +98 22 27120
Email: Masoud_1241@yahoo.co.uk
Affiliation:  Ilam University of Medical Sciences
Name: Dr Asadollahi Ruhangiz   
Address:  Dept. Pathology, Banganjab, Faculty of Medicine, Ilam University of Medical Sciences, Ilam Iran (Islamic Republic of)
Telephone: +98 22 27126
Email: roohiasadollahi@yahoo.com
Affiliation:  Ilam University of Medical Sciences
Key inclusion & exclusion criteria
Inclusion criteria: Including criteria: h. pylori infected gastric patients
Excluding criteria: pregnancy; lactation; recent antibiotic application (6 recent weeks); recent attempt for h. pylori treatment; recent surgery of stomach; positive history of alcohol consumption or addiction; having infections or malignancies in other organs; cardiovascular diseases; diabetes; IBD .

Exclusion criteria:

Age minimum: no limit
Age maximum: no limit
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic gastritis, unspecified
Gastritis.
Chronic gastritis, unspecified
k 29.5
Intervention(s)
Intervention 1: Intervention group: Using three drugs regimen (bismuth sub citrate (120mg/kg QD), tetracycline (500mg QD) and metronidazole (400 mg/kg TD)) + Q10 coenzyme (2 mg/kg/day) for 6 weeks.
The types and dosages of drugs are not changed during treatment period. Intervention 2: Control group: Using three drugs regimen (bismuth sub citrate (120mg/kg QD), tetracycline (500mg QD) and metronidazole (400 mg/kg TD)) + placebo (lactolose) for 6 weeks.
The types and dosages of drugs are not changed during treatment period.
Intervention group: Using three drugs regimen (bismuth sub citrate (120mg/kg QD), tetracycline (500mg QD) and metronidazole (400 mg/kg TD)) + Q10 coenzyme (2 mg/kg/day) for 6 weeks.
The types and dosages of drugs are not changed during treatment period.
Control group: Using three drugs regimen (bismuth sub citrate (120mg/kg QD), tetracycline (500mg QD) and metronidazole (400 mg/kg TD)) + placebo (lactolose) for 6 weeks.
The types and dosages of drugs are not changed during treatment period.
Treatment - Drugs
Primary Outcome(s)
Glutation peroxidise. Timepoint: Start and end of study. Method of measurement: Serum level of studied marker by standard kits.
Malondialdehyde. Timepoint: Start and end of study. Method of measurement: Serum level of studied marker by standard kits.
Total antioxidant capacity (TAC). Timepoint: Start and end of study. Method of measurement: Serum level of studied marker by standard kits.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Vice Chancellor for researchesand Technology, Ilam University of Medical Sciences
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
?Ethics committee of Ilam University of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
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