Protocol summary

Summary
This study is a double blind clinical trial. Ninety thalassemic patients that refer to Shohada Hospital Lordegan-University of Medical Sciences were selected. All patients have blood transfusion and consume Desferal. Main inclusion criteria for selected Patients are ages of 10-60 years that have regular blood transfusion and chelation intermittent at least four days a week. All Patients under ten years old, hepatitis and HIV positive, heart failure, kidney disease, pregnant women and patients who don’t respond to chelation therapy will be excluded. Patients will be divided in to two groups randomly. In this way,patients who complete consent, are identifed with numbers. so the patients in each group are selected randomly from among these numbers.. The case group will received daily amount of 300 mg of Oak extract for four months. Control group received placebo for same time. Placebo and Oak extract will prepare in capsule form and classified as A and B code. Blood sample will be collected from patients before and after of study. Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline phosphatase, triglyceride, total cholesterol, HDL-c, glucose, uric acid, bilirubin, Fe, BUN and creatinine, Malone dialdehayde, Ferritin, carbonylated protein, catalase, superoxide dismutase, glutathione peroxidase and total antioxidant capacity of all sample will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040427205N1
Registration date: 2016-06-27, 1395/04/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Mahdi Babamir
Name of organization / entity
Shahrekord University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 383331671
Email address
st-babamir.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University Medical Science
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of aqueous extract of Iranian oak (Quercus brantii) on antioxidant capacity and stress oxidative of thalassemia patients
Public title
Evaluation of effects of aqueous extract of Iranian oak (Quercus brantii) on antioxidant capacity and stress oxidative of thalassemia patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients with thalassemia major 2. patients with regular blood transfusions 3. Patients who received chelation therapy (desferal) at least four days a week 4. 10-60 years old 5. getting informed consent Exclusion criteria: 1. Under 10 years 2. Positive Hepatitis 3. Positive HIV   4. heart failure and chronic kidney disease 5. peregnance 6. chelating not answer or other chelating use.
Age
From 10 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
During the study, patient groups not aware of the type of intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences.
Street address
Shahrekord University of Medical Science, Rahmatieh, Shahrekord
City
Shahrekod
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SKUMS.REC.1394.278

Health conditions studied

1

Description of health condition studied
Thalassaemia
ICD-10 code
icd-56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
Ferritin
Timepoint
Before and after of study
Method of measurement
ELIZA

2

Description
Iron
Timepoint
Before and after of study
Method of measurement
Biochemical Auto analizer

3

Description
Glutathione peroxidase
Timepoint
Before and after of study
Method of measurement
Spectrophotometric

4

Description
Catalase
Timepoint
Before and after of study
Method of measurement
Spectrophotometric

5

Description
Superoxide dismutase
Timepoint
Before and after of study
Method of measurement
Spectrophotometric

6

Description
carbonyl protein
Timepoint
Before and after of study
Method of measurement
Spectrophotometric

7

Description
Malondialdehyde
Timepoint
Before and after of study
Method of measurement
HPLC

8

Description
Total Capacity Antioxidant
Timepoint
Before and after of study
Method of measurement
Spectrophotometric

Secondary outcomes

1

Description
Alanin Transferase
Timepoint
Before and after of study
Method of measurement
Biochemical auto analyzer

2

Description
Aspartate amino transferase
Timepoint
Before and after of study
Method of measurement
Biochemical auto analyzer

3

Description
Triglyceride
Timepoint
Before and after of study
Method of measurement
Biochemical auto analyzer

4

Description
Cholestrol
Timepoint
Before and after of study
Method of measurement
Biochemical auto analyzer

Intervention groups

1

Description
Intervention group : Patients with thalassemia major will receive two capsules daily for four months each capsule contains 150 mg extract oak
Category
Treatment - Drugs

2

Description
Control group: thalassemia Patients in the control group will receive two placebo capsule daily for four months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Lordegan Shohada Hospital
Full name of responsible person
Vice chancellor for research, Shahrekord University of Medical Sciences
Street address
Kashani Street ; Shahrekord, Shahrekord University of Medical Sciences
City
Sharekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sharekord University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Sharekord University of Medical Sciences
Street address
Kashani Blvd:, Kashani St:, Shahrekord, Vice chancellor for research, Shahrekord university of medical science
City
Shrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sharekord 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
Sharekord University of Medical Science
Full name of responsible person
Mahdi Babamir
Position
MSc
Other areas of specialty/work
Street address
Parastar ST', Lordegan, Lordegan Shoahada Hospital
City
Lordegan
Postal code
8891733365
Phone
+98 38 3444 4445
Fax
+98 38 3333 0790
Email
Mahdibabamir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sharekord University of Medical Sciences
Full name of responsible person
Seied Asadallah Amini
Position
Assistant professor
Other areas of specialty/work
Street address
Rahmatieh, Shahrekord, Sharekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3333 1471
Fax
+98 38 3444 0790
Email
Sa.amini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sharekord University of Medical Sciences
Full name of responsible person
Mahdi Babamir
Position
Master of Science
Other areas of specialty/work
Street address
Rahmatieh, Shahrekord, Sharekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 3333 1671
Fax
Email
Mahdibabamir@yahoo.com
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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