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Ganshuang Keli granule in the treatment of chronic hepatitis and liver fibrosis: a multiple randomised controlled trial

Ganshuang Keli granule in the treatment of chronic hepatitis and liver fibrosis: a multiple randomised controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003726
Enrollment
Unknown
Registered
2013-08-23
Start date
2013-09-01
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

chronic hepatitis and liver fibrosis

Interventions

Experimental Group:Ganshuang Keli+Silybin Meglumine
Control Group:Silybin Meglumine

Sponsors

302 Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 65 years, both gender; 2. The HBV marker positive reaction continues at least 6 months before recruitment; 3. The serum ALT level is 1.5 to 10 times higher than normal upper threshold; or at least two items of the four items of fibrosis is 1.2 times higher than normal upper threshold; or liver tissue pathology finding suggested the inflammation G=2 or fibrosis S=2; 4. Serum total bilirubin less than 51 umol/L; 5. Not received anti-fibrosis and immunomodulatory agents therapy in past six months of before recruitment; 6. The patient or the legal representative can understand and sign the informed consent, to be able to communicate with the researchers and cooperate with the researchers to perform the protocol.

Exclusion criteria

Exclusion criteria: 1. To be confirmed with decompensated cirrhosis; original/metastatic liver cancer; Autoimmune liver disease; Drug-induced liver disease; Alcoholic liver disease; Toxic liver damage; 2. PLT200 ng/ml; 5. Has a history of alcoholism or drug addiction; History of peptic ulcer or asthma; Serious endocrine and heart, lung, and kidney diseases; 6. Using other drugs or therapies which will affect the assessment or the treatment of the hepatitis during the study; 7. The patient is treating or in past three months treated by the same drugs; 8. Pregnancy woman, lactating woman or the woman plan to pregnancy; 9. Mental disease patient.

Design outcomes

Primary

MeasureTime frame
liver function indicators;serum fibrosis index;Immunological indicators;Clinical indications;The degree of fibrosis;Fibroscan Liver stiffness;Portal vein and splenic vein width?spleen pachydia;

Countries

China

Contacts

Public ContactChen Yu

302 Hospital of PLA

chybeyond@163.com+86 13391663900

Outcome results

None listed

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