Non-Transfusion-Dependent Thalassemia Thalassemia, Curcumin, Turmeric Extract, Antioxidants, Malondialdehyde
Conditions
Interventions
Curcuminoids Capsule 500 mg,Curcuminoids Capsule 1000 mg,Placebo
Standard treatment with NANTH GPO Klobinex 500 mg,Standard treatment with NANTH GPO Klobinex 1000 mg,Standard treatment with Placebo
Sponsors
Technology and Innovation in Life Sciences National (TILSNA)
Eligibility
Sex/Gender
All
Age
13 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 13 to 60 years. 2. Body weight at least 30 kg. 3. Confirmed diagnosis of thalassemia, including: Beta-thalassemia/Hb E, either beta-plus or beta-zero, confirmed by DNA analysis; or Alpha-thalassemia (Hb H disease), including deletional, non-deletional, or double heterozygous forms with beta-thalassemia. 4. Hemoglobin level at least 6 g/dL. 5. Participants receiving iron chelation therapy must have been on a stable dose of deferiprone (L1), deferoxamine (DFO), and/or deferasirox (Exjade) for at least 12 weeks prior to screening. 6. Participants must agree to use highly effective contraception throughout the study period. 7. Participants who understand the study requirements and voluntarily provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Participants requiring regular red blood cell transfusions, defined as: Receipt of more than 5 units of red blood cells within 24 weeks prior to study entry; and/or Receipt of a red blood cell transfusion within 8 weeks prior to study entry. 2. Female participants who are pregnant or breastfeeding. 3. Use of anticoagulants, including warfarin, enoxaparin, or heparin, and/or vitamin E within 30 days prior to screening. 4. Abnormal liver function, defined as ALT and/or AST greater than 3 times the upper limit of normal. 5. Impaired renal function, defined as eGFR less than 60 mL/min/1.73 m2. 6. Continuous use of anticoagulant therapy, such as warfarin or direct oral anticoagulants 7. History of hypersensitivity to the study drug or any of its components. 8. Uncontrolled gastrointestinal obstruction that cannot be treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Malondialdehyde Month 3, 6, 9 blood sample analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Antioxidant capacity Month 3, 6, 9 Blood sample analysis,Reticulocyte count Month 3, 6, 9 Blood sample analysis,Lactate Dehydrogenase Month 3, 6, 9 Blood sample analysis,Serum Erythropoietin Month 3, 6, 9 Blood sample analysis,Fasting blood sugar Month 3, 6, 9 Blood sample analysis,Quality of life Month 3, 6, 9 PedsQL questionnaire,Quality of life Month 3, 6, 9 SF-36 questionnaire,Hemoglobin Month 3, 6, 9 Blood sample analysis,Hematocrit Month 3, 6, 9 Blood sample analysis,Red blood cell count Month 3, 6, 9 Blood sample analysis,White blood cell count Month 3, 6, 9 Blood sample analysis,Mean corpuscular volume Month 3, 6, 9 Blood sample analysis,Mean corpuscular hemoglobin Month 3, 6, 9 Blood sample analysis,Platelet count Month 3, 6, 9 Blood sample analysis,Neutrophils Month 3, 6, 9 Blood sample analysis,Lymphocytes Month 3, 6, 9 Blood sample analysis,Monocytes Month 3, 6, 9 Blood sample analysis,Eosinophils Month 3, 6, 9 Blood sample analysis,Basophils Month 3, 6, 9 Blood sample analysis,Serum ferritin Month 3, 6, 9 Blood sample analysis,Serum non-transferrin bound iron Month 3, 6, 9 Blood sample analysis,Serum hepcidin Month 3, 6, 9 Blood sample analysis,Total iron-binding capacity Month 3, 6, 9 Blood sample analysis,Erythroferrone Month 3, 6, 9 Blood sample analysis,Soluble transferrin receptor Month 3, 6, 9 Blood sample analysis,Growth differentiation factor 15 Month 3, 6, 9 Blood sample analysis | — |
Countries
Thailand
Contacts
Public ContactChattree Hantaweepant
Faculty of Medicine Siriraj Hospital
Outcome results
None listed