Objective: the aim of this study was evaluation and comparison of the efficacy and safety of herbal product (Resveratrol) with HU in non- transfusion- dependent B-thalassemia-intermedia. Inclusion criteria: non transfused in the 6 months ago; patients who did not receive HbF- inducer in the 6 months ago; normal liver or kidney function tests; normal CBC test.
Exclusion criteria: Patients will be excluded from this trial if they have one of the following criteria:
Abnormal liver or kidney function tests; An alanine aminotranferase (ALT) level and aspartate aminotransferase (AST) greater than 3 fold; serum creatinine level above the upper limit of normal; they can leave the study when they want. Target sample size was sixty. Intervention studied was Resveratrol 1 gr/day orally, Hydroxyurea 10-15(mg/kg/day). Variation in Hb, HbF (every month for 6 months) and need to transfusion was evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112320051N2
Registration date:2015-08-19, 1394/05/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Mehran Karimi
Name of organization / entity
Hematology Research Center, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5617
Email address
karimim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of herbal product (Resveratrol) with Hydroxyurea (HU) in non- transfusion- dependent B-thalassemia-intermedia
Public title
Evaluation and comparison of the efficacy and safety of Resveratrol withHydroxyurea (HU) in B-thalassemia-intermedia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non transfused in the 6 months ago; patients who did not receive HbF- inducer in the 6 months ago; normal liver or kidney function tests; normal CBC test.
Exclusion criteria: Patients will be excluded from this trial if they have one of the following criteria: Abnormal liver or kidney function tests; An alanine aminotranferase (ALT) level and aspartate aminotransferase (AST) greater than 3 fold; serum creatinine level above the upper limit of normal; they can leave the study when they want
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Convenience sampling
randomization was done using block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.SUMS.REC.1394.16
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Thalassemia Intermedia
Primary outcomes
1
Description
1:HB
Timepoint
Base line,End of every month,End of study
Method of measurement
CBC
2
Description
2: HbF
Timepoint
base line,End of every month,End of study
Method of measurement
Hemoglobin Electrophoresis
Secondary outcomes
1
Description
1:Saftey
Timepoint
Base line,End of evey month,end of study
Method of measurement
Follow up,clinical examination by expert hematologist
2
Description
2:Possible gastrointestinal side effects ,including diarrhea
Timepoint
Base line,End of every month,End of study
Method of measurement
Follow up,clinical examination by expert hematologist
Intervention groups
1
Description
Intervention group 1: patients treated with HU, Resveratrol Resveratrol 1 gr/day orally, Hydroxyurea 10-15(mg/kg/day)
Category
Treatment - Drugs
2
Description
Control group: including Placebo + Hydroxyurea 10-15 mg/kg/day
Category
Placebo
3
Description
Intervention group 2: including Resveratrol 1 gr/day orally + Placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology Research Center
Full name of responsible person
Mozhgan Rezaei
Street address
Hematology Research Center, Nemazee Hospital, Zand street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Mehran Karimi
Street address
Hematology Research Center, Nemazee Hospital, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz 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
Hematology Research Center, Nemazee Hospital, Shiraz
Full name of responsible person
Sezaneh Haghpanah
Position
Assistance professor of community medicine
Other areas of specialty/work
Street address
Hematology Research Center, Nemazee Hospital, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3628 1563
Fax
Email
haghpanah@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehran Karimi
Position
Professor of Pediatric Hematology-Oncology Hematology Research Center
Other areas of specialty/work
Street address
Hematology Research Center, Nemazee Hospital, Zand street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3628 1563
Fax
Email
karimim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hematology Research Center, Nemazee Hospital, Shiraz
Full name of responsible person
Tahereh Zarei
Position
Msc Microbiologist
Other areas of specialty/work
Street address
Hematology Research Center, Nemazee Hospital, Zand street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3628 1528
Fax
Email
zarei_t@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)