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Silibinin Capsules (Shui Linjia) for the prevention of tuberculosis drugs induced liver injury, randomized, multi center, opening clinical study

Silibinin Capsules (Shui Linjia) for the prevention of tuberculosis drugs induced liver injury, randomized, multi center, opening clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004857
Enrollment
Unknown
Registered
2014-06-12
Start date
2012-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Tuberculosis

Interventions

The test group:Silibinin capsule + anti tuberculosis drugs
Control group:anti tuberculosis drugs only

Sponsors

Tongji University Affiliated Hospital of Shanghai City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~65 years male or female; 2. pulmonary tuberculosis cases, released in January 16, 2008,with the Ministry of health; 3. Before treatment were not used anti tuberculosis drugs; 4. Before treatment, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AKP) and total bilirubin (TBiL), direct bilirubin (DBiL) were within the normal range.

Exclusion criteria

Exclusion criteria: 1. Patients with liver diseases (such as alcoholic liver disease, autoimmune liver disease, liver disease, with active hepatitis B and C); 2. Serious heart, brain, kidney, gastrointestinal disorders and systemic system; 3. HIV infection; 4. At the same time, the application effect of the drug efficacy; 5. Study on drug allergy or intolerance; 6. Patients have no ability to express their complaints, such as psychosis and neurosis are serious; 7. Poor compliance are not cooperation; 8. Pregnant and lactating women, or women preparing for pregnancy; 9. Other clinical researchers in 3 months; 10. Study physicians believe not suitable situation

Design outcomes

Primary

MeasureTime frame
ALT;AST;AKP;TBiL;DBiL;TP;ALB;TB in Sputum smear;TB in Sputum culture;Abdominal B Ultrasoun;

Secondary

MeasureTime frame
WBC;Neutrophil count;Lymphocyte count;Eosinophil count;Hb;PLT;Urinary RBC;Urinary WBC;Urinary PRO;X-ray film;

Countries

China

Contacts

Public ContactHeping Xiao

Tongji University Affiliated Hospital of Shanghai City

xiaoheping_sars@163.com+86 13391497502

Outcome results

None listed

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