NCT07157722

Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia

The Potential Role of N-Acetyl Cysteine or Alpha-Lipoic Acid as Adjuvant Therapies in the Treatment of Patients With Beta Thalassemia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia.

Detailed description

Beta-thalassemia (β-thalassemia) is a hereditary blood disorder, which is characterized by a genetic disorder in the production of β-globin chains. β-thalassemia is inherited mainly by an autosomal recessive manner resulting in reduced synthesis or absence of β-globin chains, leading to ineffective erythropoiesis and chronic hemolytic anemia. It is classified according to the severity into major, intermedia and minor. This is a randomized, parallel, clinical study that will be conducted on sixty-six patients with beta-thalassemia. The study duration will be 12 weeks. Patients will be divided into three groups as follows: Group I (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only. Group II (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for three months. Group III (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for three months. The study will be approved by the Research Ethical Committee at Faculty of Pharmacy, Tanta University. All participants will be informed about benefits and risks of the study. The privacy of all participants will be respected and the data of enrolled participants will be confidential. All participants will sign their written informed consent.

Conditions

• Beta Thalassemia

Interventions

Type	Name	Description
DRUG	Iron chelating intervention	JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.
DRUG	N Acetyl cysteine 600mg	N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks.
DRUG	Alpha Lipoic Acid 600 MG Oral Tablets	Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks.

Timeline

• Start date: 2025-08-30
• Primary completion: 2025-12-30
• Completion: 2026-01-30
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: Egypt