This study aimed to evaluate the antioxidant effects of Q10 co-enzyme on oxidative stress and lipid per-oxidation among gastric patients caused by h. pylori infection. By a randomized control trail 100 gastric patients with confirmed h. pylori infection are entered into the study and are divided into intervention and control groups. Including criteria are having gastritis infected by h.pylori and excluding criteria are pregnancy, vascular diseases and diabetes. Total sample size is 100 patients and placebo group (50 patients) receive three drugs regimen+ placebo and treatment group (50 patients) receive three drugs regimen+ Q10 co enzyme both for 6 weeks. Three drugs regimen used in this study included bismuth sub citrate (120mg/kg QD), tetracycline (500mg QD) and metronidazole (400 mg/kg TD). The study was double blind for both patients and data collectors. The primary outcome measurments are the serum levels of glutation peroxidase, malondialdehyde and total antioxidant capacity at the start and end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070118310N1
Registration date:2014-09-10, 1393/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-10, 1393/06/19
Registrant information
Name
Ghobad Abangah
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1334 3456
Email address
abangah-gh@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
ِVice Chancellor of Researches and Technical information, Banganjab, Ilam University of Medical Sciences, Ilam, Iran
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Public title
The antioxidant effects of Q10 co enzyme on oxidative stress and lipid per oxidation among gastric patients infected by h.pylori
Purpose
Treatment
Inclusion/Exclusion 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 .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Ilam University of Medical Sciences
Street address
ٍEthics committee, Banganjab, Deputy of Researches and Technical Information, Ilam University of Medical Sciences
City
Ilam
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
EC/92/H/213
Health conditions studied
1
Description of health condition studied
Gastritis
ICD-10 code
k 29.5
ICD-10 code description
Chronic gastritis, unspecified
Primary outcomes
1
Description
Total antioxidant capacity (TAC)
Timepoint
Start and end of study
Method of measurement
Serum level of studied marker by standard kits
2
Description
Glutation peroxidise
Timepoint
Start and end of study
Method of measurement
Serum level of studied marker by standard kits
3
Description
Malondialdehyde
Timepoint
Start and end of study
Method of measurement
Serum level of studied marker by standard kits
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gasterointestinal clinic
Full name of responsible person
Dr Abangah Ghobad
Street address
Gasterointestinal clinic, 22 Bahman Square,
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for researchesand Technology, Ilam University of Medical Sciences
Full name of responsible person
Dr Morovat Taherikalani
Street address
Vice Chancellor for researches and Technology, Banganjab, Ilam University of Medical Sciences
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for researchesand Technology, Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Asadollahi Ruhangiz
Position
Pathologist
Other areas of specialty/work
Street address
Dept. Pathology, Banganjab, Faculty of Medicine, Ilam University of Medical Sciences,
City
Ilam
Postal code
Phone
+98 22 27126
Fax
Email
roohiasadollahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Asadollahi Khairollah
Position
Associate prof., Epidemiologist
Other areas of specialty/work
Street address
Dept. Epidemiology, Banganjab, Faculty of Medicine, Ilam University of Medical Scences
City
Ilam
Postal code
Phone
+98 22 27120
Fax
Email
Masoud_1241@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)