Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia
NCT ID: NCT07157722
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
66 participants
INTERVENTIONAL
2025-08-30
2026-01-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Group 1: (Iron chelating agent group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only.
Iron chelating intervention
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.
Group 2: (Iron chelating agent + NAC group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks.
Iron chelating intervention
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.
N Acetyl cysteine 600mg
N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks.
Group 3: (Iron chelating agent + ALA group)
Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks.
Iron chelating intervention
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.
Alpha Lipoic Acid 600 MG Oral Tablets
Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks.
Interventions
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Iron chelating intervention
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.
N Acetyl cysteine 600mg
N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks.
Alpha Lipoic Acid 600 MG Oral Tablets
Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Both genders.
* Age ≥ 18 years old.
Exclusion Criteria
* Patients with a prior history of significant cardiovascular diseases, such as coronary artery disease, myocardial infarction, or stroke.
* Patients with severe renal dysfunction.
* Patients with severe hepatic dysfunction.
* Patients with diabetes.
* Patients who will be non-compliant with the prescribed therapy.
* Patients with other hemoglobinopathies.
* Pregnant women.
* Obese patients.
* Patients who will receive antioxidant or anti-inflammatory medications.
* Patients with inflammatory diseases, such as Systemic lupus erythematous, rheumatoid arthritis and inflammatory bowel disease.
* Patients with oxidative stress related diseases, such as Alzheimer, Parkinson, COPD and cancer.
18 Years
70 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Mahmoud Mohamed Elkholy
Teaching Assistant
Principal Investigators
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Sahar M El-Haggar, Professor
Role: STUDY_DIRECTOR
Tanta University
Tarek M Mostafa, Professor
Role: STUDY_DIRECTOR
Tanta University
Basma A Mansour, Lecturer
Role: STUDY_DIRECTOR
Faculty of Medicine - Mansoura University
Mohammed A El hawary, Assistant Professor
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine - Mansoura University
Mahmoud M Elkholy, Teaching Assistant
Role: PRINCIPAL_INVESTIGATOR
Tanta University
Locations
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Faculty of Pharmacy - Tanta University
Tanta, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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9250572
Identifier Type: -
Identifier Source: org_study_id
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