Beta-thalassemia with iron overload, including transfusion-dependent thalassemia (TDT) and non-transfusion-dependent thalassemia (NTDT). Beta-thalassemia iron overload EGCG ferritin
Conditions
Interventions
The investigational product in this study is NOW Green Tea Extract 400 mg per capsule. Each capsule contains epigallocatechin gallate or EGCG 200 mg with Thai-FDA approved. Participants randomized to
Experimental Dietary Supplement,No Intervention No treatment
Epigallocatechin 3 gallate (EGCG),Standard Iron chelation
Sponsors
Department of Medicine, Phramongkutklao Hospital Foundation
The Thai Society of Hematology
Eligibility
Sex/Gender
All
Age
20 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged more than 20 years. 2. Confirmed diagnosis of beta-thalassemia, either transfusion-dependent thalassemia (TDT) or non-transfusion-dependent thalassemia (NTDT). 3. Receiving stable iron chelation therapy with deferasirox or deferiprone for at least 12 weeks before screening. 4. Serum ferritin level at screening between 300 and 3,000 ng/mL. 5. Alanine aminotransferase (ALT) level less than 3 times the upper limit of normal (ULN). 6. Able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Hemoglobin level less than 5 g per dL at screening. 2. Change in the type or dose of iron chelation therapy within 12 weeks before screening, or anticipated change within the first 6 months of the study. 3. Use of luspatercept or mitapivat within 6 months before screening. 4. History of allergy or hypersensitivity to EGCG or green tea products. 5. Pregnant, planning to become pregnant, or breastfeeding. 6. Clinically severe or unstable cardiac, renal, or endocrine disease. 7. Evidence of active viral hepatitis infection, defined as positive HBsAg or positive HCV RNA, or chronic liver disease from causes other than iron overload. 8. Participation in another interventional clinical trial within 30 days before screening. 9. Regular daily consumption of green tea or EGCG containing supplements within 3 months before screening. 10. Any medical condition that, in the judgment of the investigator, may pose a risk to the participant or interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum ferritin at visit week 12 Ferritin | — |
Secondary
| Measure | Time frame |
|---|---|
| serum ferritin at visit week 24 ferritin,Safety outcome every visit (visit week 0,4,12,24) serum CBC Bun Cr LFT electrolytes and other side effects,safety outcome every visit (visit week 0,4,12,24) side effects of intervention | — |
Countries
Thailand
Contacts
Public ContactSarisa Tongkaew
Phramongkutklao Hospital
Outcome results
None listed