Evaluation and comparison of the efficacy and safety of Resveratrol withHydroxyurea (HU) in B-thalassemia-intermedia

Comparison of the efficacy and safety of herbal product (Resveratrol) with Hydroxyurea (HU) in non- transfusion- dependent B-thalassemia-intermedia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014112320051N2

Enrollment

Registered

2015-08-19

Start date

2015-08-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia. Thalassemia Intermedia

Interventions

Intervention 1: Intervention group 1: patients treated with HU, Resveratrol Resveratrol 1 gr/day orally, Hydroxyurea 10-15(mg/kg/day). Intervention 2: Control group: including Placebo + Hydroxyurea 1

Treatment - Drugs

Placebo

Intervention group 1: patients treated with HU, Resveratrol Resveratrol 1 gr/day orally, Hydroxyurea 10-15(mg/kg/day)

Control group: including Placebo + Hydroxyurea 10-15 mg/kg/day

Intervention group 2: including Resveratrol 1 gr/day orally + Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSezaneh Haghpanah

Hematology Research Center, Nemazee Hospital, Shiraz

haghpanah@sums.ac.ir+98 71 3628 1563

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026