Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804022067N1
Registration date:2009-10-02, 1388/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-10-02, 1388/07/10
Registrant information
Name
Marjan Gharagozloo
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 22428
Email address
gharagozlo@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Isfahan, Iran, and
Expected recruitment start date
2009-05-12, 1388/02/22
Expected recruitment end date
2009-08-30, 1388/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined therapy of silymarin and desferrioxamine in patients with b-thalassemia major: a randomized double-blind clinical trial
Public title
Therapeutic effect of silymarin in beta-thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Presence of major Beta-thalassemia, age 12 years or older, iron overload condition (with serum ferritin levels between 1000-5000 ng/mL) during 6 months prior to study, regular deferoxamine administration (50 mg/kg), receiving continuous blood transfusions maintained at a hemoglobin level of 9.5 g/dl, negative CRP test at the beginning of the study Exclusion criteria: Presence of hepatitis B or C infection, positive HIV test, gastrointestinal problemss preventing absorption of an oral medication presence of chronic renal or heart failure, iron chelating therapy with iron chelators other than desferrioxamine, pregnancy
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Isfahan University of Medical Sciences
Street address
Hezar jerib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2008-12-22, 1387/10/02
Ethics committee reference number
187050
Health conditions studied
1
Description of health condition studied
Beta-Thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta-Thalassemia major
Primary outcomes
1
Description
Serum ferritin
Timepoint
3 months and 6 months from beginning of the trial
Method of measurement
ELISA assay
2
Description
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase)
Timepoint
3 months and 6 months from beginning of the trial
Method of measurement
ELISA assay
Secondary outcomes
empty
Intervention groups
1
Description
Silymarin Capsule, 140 mg, 3 times a day + desferal 50 mg/kg
Category
Treatment - Drugs
2
Description
Placebo capsules Similar to Silymarin + desferal injection 50 mg/kg
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al Shohada hospital, Thalassemia devision, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Hamid Hourfar
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi,
Street address
Vice-chancellery of Research Affairs, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
ROTTAPHARM | MADAUS
Full name of responsible person
Dr. Horst-Ulrich Tuellner
Street address
Madaus GmbH, Colonia Allee 15, 51067 Köln
City
Köln
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ROTTAPHARM | MADAUS
Proportion provided by this source
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Immunology, Isfahan Medical School
Full name of responsible person
Dr. Marjan Gharagozloo
Position
Assistant professor, PhD
Other areas of specialty/work
Street address
Medical School, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2428
Fax
Email
gharagozlo@sums.ac.ir, gharagozlo@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Immunology, School of Medicine
Full name of responsible person
Nafiseh Esmaeil
Position
MSc
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
Fax
Email
nafesm5@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)