Evaluation and comparison of the efficacy and safety of Resveratrol withHydroxyurea (HU) in B-thalassemia-intermedia
Phase 3
- Conditions
- Thalassemia.Thalassemia Intermedia
- Registration Number
- IRCT2014112320051N2
- Lead Sponsor
- Vice Chancellor for Research, Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1:HB. Timepoint: Base line,End of every month,End of study. Method of measurement: CBC.;2: HbF. Timepoint: base line,End of every month,End of study. Method of measurement: Hemoglobin Electrophoresis.
- Secondary Outcome Measures
Name Time Method 1:Saftey. Timepoint: Base line,End of evey month,end of study. Method of measurement: Follow up,clinical examination by expert hematologist.;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.