Evaluation of the effect of the combination of coenzyme Q10, alpha-lipoic acid, and acetyl-L-carnitine compared to placebo in the prevention of anti-tuberculosis drugs-induced hepatotoxicity

Evaluating the effect of the combination of CoQ10, alpha-lipoic acid, and acetyl-L-carnitine in the prevention of hepatotoxicity in patients receiving anti-tuberculosis drugs

Randomized, Parallel Group, Placebo-Controlled Clinical Trial

Patients who had inclusion criteria were randomly assigned to two groups of experimental and placebo. All patients received standard anti-TB regimen. The patients of experimental group used drug capsules, while the patients of placebo group received placebo capsules twice daily for 2 weeks. Serum levels of ALT, AST, ALP and total bilirubin were measured before the intervention and then weekly for to 2 weeks.

Inclusion criteria: Age ≥ 18 years old; pulmonary or extrapulmonary tuberculosis; taking first-line anti-TB drugs (Isoniazid, Rifampin and Pyrazinamide) Exclusion criteria: taking first-line anti-TB drugs within the last 8 weeks; use of known hepatotoxic drugs (e.g., sodium valproate, methotrexate, sulfonamides); regular use of acetaminophen; use of systemic glucocorticoids; use of any supplements containing CoQ10 or alpha-lipoic acid or L-carnitine within the last 4 weeks; use of alcohol; use of antioxidants (such as vitamins E and C); chronic liver or kidney disease; pregnancy; and lactation

Experimental group: taking capsules containing the combination of CoQ10, alpha-lipoic acid, and acetyl-L-carnitine, twice daily concurrently with the initiation of standard anti-tuberculosis drug regimen, for 2 weeks Control group: taking placebo capsules, twice daily concurrently with the initiation of standard anti-tuberculosis drug regimen, for 2 weeks

1. Serum levels of ALT and AST and ALP 2. Serum level of total bilirubin 3. The number of patients with drug-induced liver injury

Simple randomization was used for patients' allocation to the groups. For this, an online random number generator was used (available at: https://www.random.org/sequences) so that even and odd numbers were considered for experimental and placebo groups, respectively, and each patient, after inclusion, was assigned to the related group according to the determined sequence.

Drug and placebo capsules will be fully similar and packaged in similar containers. The patient, the prescriber (physician), data analyst, and the laboratory personnel will be blind to the content of containers and intervention type.

Confidentiality of patients' data