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Evalution of Curcumin on level of oxidative stress factors and gastric histoplathology in patients with chronic gastrits related to helicobacter pylori

Protocol summary

Summary
This study investigated the effects of curcumin on the level of oxidative factors and gastric histopathology in patients with chronic gastritis associated with Helicobacter pylori. Inclusion criteria: Age between 18 to 65 years , confirm of chronic gastritis according to histopathologic assay, presence of abdominal symptoms related to chronic gastritis. Exclusion criteria: recent use of antibiotics in the last 6 months, pregnancy, lactation, recent surgical procedures, alcohol, systemic diseases like coronary artery disease, diabetes, collagen vascular and central nervous system , age <18 years and above 70 years.Patients were divided into two groups of triple therapy regimen and triple therapy regimen+ curcumin. Triple therapy was used in this study as bismuth subcitrate 120 mg / kg four times a day, tetracycline 500 mg / kg four times a day and metronidazole 400 mg / kg three times daily. curcumin was administered by 30 mg two time daily . During the study period was 2 months.All patients were evaluated wtih endoscopy before and after the intervention. for all patients Histological analysis was performed. gastric mucosal levels of also examined for factors related with oxidative stress, DNA damage and the prostaglandin E2.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016012826238N1
Registration date: 2016-03-10, 1394/12/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-10, 1394/12/20
Registrant information
Name
Arezo Judaki
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7150
Email address
arezo.judaki@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Science, School of Medicine.
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalution of Curcumin on level of oxidative stress factors and gastric histoplathology in patients with chronic gastrits related to helicobacter pylori
Public title
Effect of Curcumin on chronic gastritis related to helicobacter pylori
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 65 years؛ confirm of chronic gastritis according to histopathologic assay؛ presence of abdominal symptoms related to chronic gastritis. Exclusion criteria: recent use of antibiotics in the last 6 months؛ pregnancy؛ lactation؛ recent surgical procedures؛ alcohol؛ systemic diseases like coronary artery disease؛ diabetes؛ collagen vascular and central nervous system؛ age <18 years and above 70 years.
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)
N/A
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
Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences
City
Ilam
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
ir.medilam.ac.rec.1394.184

Health conditions studied

1

Description of health condition studied
Chronic Gastritis
ICD-10 code
K29.5
ICD-10 code description
Chronic gastritis, unspecified

Primary outcomes

1

Description
Malondialdehyde
Timepoint
Initial and after 8 weeks
Method of measurement
Randox Kit

2

Description
Total Antioxidant Capacity
Timepoint
Initial and after 8 weeks
Method of measurement
Randox Kit

3

Description
Glutathione peroxidase
Timepoint
Initial and after 8 weeks
Method of measurement
Randox Kit

4

Description
prostaglandin E2
Timepoint
Initial and after 8 weeks
Method of measurement
RAI

5

Description
Chronic Gastritis
Timepoint
Initial and after 8 weeks
Method of measurement
Histology

6

Description
Endoscopic Inflammation Score
Timepoint
Initial and after 8 weeks
Method of measurement
Endoscopy

7

Description
DNA Oxidative Damage
Timepoint
Initial and after 8 weeks
Method of measurement
DNA Oxidative Damage Kit

Secondary outcomes

empty

Intervention groups

1

Description
Control group: triple therapy bismuth subcitrate 120 mg / kg four times a day, tetracycline 500 mg / kg four times a day and metronidazole 400 mg / kg three times daily.
Category
Treatment - Drugs

2

Description
triple therpy +Curcumin with 30 mg/twice in day for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Gastroenterology Clinic
Full name of responsible person
Arezu Judaki
Street address
City
Ilam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Kourosh Sayhemiri
Street address
Ilam University of Medical Sciences, Boulevard Research, Ban Ganjab, Ilam,Iran.
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Science
Full name of responsible person
Dr Mohammad Reza Hafezi Ahmadi
Position
Pathologist
Other areas of specialty/work
Street address
School of Medicine , Ilam University of Medical Science
City
Ilam
Postal code
Phone
+98 84 3224 3320
Fax
Email
reza.ahmadi.54@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Science
Full name of responsible person
Dr Arezo Judaki
Position
Gastroenterologist
Other areas of specialty/work
Street address
Ilam, Ilam city, Ban Ganjab, boulevard Research, University of Medical Sciences
City
Ilam
Postal code
Phone
+98 84 3224 3320
Fax
Email
Arezo.judaki@medilam.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
ilam university of medical science
Full name of responsible person
Dr Mohammad Reza Hafezi Ahmadi
Position
Patologist
Other areas of specialty/work
Street address
school of medicine
City
ilam
Postal code
Phone
+98 84 3224 3320
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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