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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• The change from baseline in carotid intima media thickness (CIMT) [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Change in Malondialdehyde (MDA) [Срок оценки: 3 months]
• Change in high sensitivity C-reactive protein (hs-CRP) [Срок оценки: 3 months]
• Change in asymmetric dimethyl arginine (ADMA) [Срок оценки: 3 months]
• Change in lipid profile [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients with beta-thalassemia who will receive conventional thalassemia management.
• Both genders.
• Age ≥ 18 years old.

Критерии исключения

• Patients with familial hypercholesterolemia or history of premature atherosclerosis.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Pharmacy - Tanta University — Tanta

Идентификаторы

NCT: NCT07157722 · 9250572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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