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Evaluation of the effect of Milk Thistle in the prevention of anti-tuberculosis drugs-induced hepatotoxicity: A randomized controlled clinical trial

Evaluation of the effect of Milk Thistle in the prevention of anti-tuberculosis drugs-induced hepatotoxicity: A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150721023282N9
Enrollment
53
Registered
2020-03-30
Start date
2017-03-21
Completion date
Unknown
Last updated
2020-04-21

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: 150-mg oral capsules of Milk Thistle, twice daily, for 2 weeks with standard 4-drug anti-TB therapeutic regimen including isoniazid 5 mg/kg + rifampin 10 mg/kg + et

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age = 18 years Pulmonary or outer pulmonary tuberculosis Taking first line of 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 Silymarin-containing supplements 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

MeasureTime frame
Serum level of ALT. Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.;Serum level of AST. Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.;Serum level of ALP. Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.;Serum level of bilirubin(direct/total). Timepoint: Before the intervention and 7 and 14 days after initiation of intervention. Method of measurement: blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasool Soltani

Esfahan University of Medical Sciences

soltani@pharm.mui.ac.ir+98 31 3786 5537

Outcome results

None listed

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