Evaluation of the effect of the combination of coenzyme Q10, alpha-lipoic acid, and acetyl-L-carnitine in the prevention of anti-tuberculosis drugs-induced hepatic adverse effect

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150721023282N11

Enrollment

Registered

2020-07-13

Start date

2017-04-04

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-tuberculosis drugs-induced hepatotoxicity. Toxic liver disease

Interventions

Intervention 1: Intervention group: oral capsules containing the combination of CoQ10 (200 mg) + alpha-lipoic acid (250 mg) + acetyl-L-carnitine (250 mg) manufactured by Vitacost cmpany, USA, twice da

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age = 18 years Pulmonary or extrapulmonary tuberculosis Taking first-line anti-TB drugs (Isoniazid, Rifampin, and Pyrazinamide) No use of first-line anti-TB drugs within the last 8 weeks

Exclusion criteria

Exclusion criteria: Use of known hepatotoxic drugs (e.g., sodium valproate, methotrexate, sulfonamides) Regular use of acetaminophen Use of systemic glucocorticoids Use of any supplements containing coenzyme Q10 or alpha-lipoic acid or L-carnitine within the last 4 weeks Alcoholism Use of antioxidant agents (e.g., vitamins E and C) Having chronic hepatic or renal disease Pregnancy Lactation

Design outcomes

Primary

Measure	Time frame
Serum level of alanine aminotransferase (ALT). Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of aspartate aminotransferase (ALT). Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of alkaline phosphatase. Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of total bilirubin. Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;The number of cases of drug-induced liver injury. Timepoint: End of intervention. Method of measurement: Based on defined criteria.	—

Measure

Time frame

Serum level of alanine aminotransferase (ALT). Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of aspartate aminotransferase (ALT). Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of alkaline phosphatase. Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;Serum level of total bilirubin. Timepoint: Before the intervention and days of 7 and 14 of intervention. Method of measurement: Blood test.;The number of cases of drug-induced liver injury. Timepoint: End of intervention. Method of measurement: Based on defined criteria.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasool Soltani

Esfahan University of Medical Sciences

soltani@pharm.mui.ac.ir+98 31 3792 7067

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026