Main
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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:
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IRCT |
Last refreshed on:
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22 February 2018 |
Main ID: |
IRCT2014070118310N1 |
Date of registration:
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2014-09-10 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The antioxidant effects of Q10 co enzyme on oxidative stress and lipid per oxidation among gastric patients infected by h.pylori
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Scientific title:
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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:
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2014-06-22 |
Target sample size:
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100 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/16638 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr Asadollahi Khairollah
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Address:
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Dept. Epidemiology, Banganjab, Faculty of Medicine, Ilam University of Medical Scences
Ilam
Iran (Islamic Republic of) |
Telephone:
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+98 22 27120 |
Email:
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Masoud_1241@yahoo.co.uk |
Affiliation:
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Ilam University of Medical Sciences |
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Name:
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Dr Asadollahi Ruhangiz
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Address:
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Dept. Pathology, Banganjab, Faculty of Medicine, Ilam University of Medical Sciences,
Ilam
Iran (Islamic Republic of) |
Telephone:
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+98 22 27126 |
Email:
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roohiasadollahi@yahoo.com |
Affiliation:
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Ilam University of Medical Sciences |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Chronic gastritis, unspecified
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Gastritis. Chronic gastritis, unspecified
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k 29.5
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Intervention(s)
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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.
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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.
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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.
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Treatment - Drugs
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Primary Outcome(s)
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Glutation peroxidise. Timepoint: Start and end of study. Method of measurement: Serum level of studied marker by standard kits.
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Malondialdehyde. Timepoint: Start and end of study. Method of measurement: Serum level of studied marker by standard kits.
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Total antioxidant capacity (TAC). Timepoint: Start and end of study. Method of measurement: Serum level of studied marker by standard kits.
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Source(s) of Monetary Support
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Vice Chancellor for researchesand Technology, Ilam University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
?Ethics committee of Ilam University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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