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The clinical theraputic optimization study of refractory chronic hepatitis C: A randimized, double-blind, multi-center clinical trail

The clinical theraputic optimization study of refractory chronic hepatitis C: A randimized, double-blind, multi-center clinical trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002804
Enrollment
Unknown
Registered
2012-09-16
Start date
2012-10-01
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 C

Interventions

YI QI JIE DU group:1 bag YI QI JIE DU bid po.
SHU GAN JIAN PI group:1 bag SHU GAN JIAN PI bid po.
BU SHEN ROU GAN group:1 bag BU SHEN ROU GAN bid po.
control group 1:1 bag placebo bid po.
control group 2:1 bag placebo bid po.
control group 3:1 bag placebo bid po.

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medcine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in the trial, and signed informed consent; 2. Aged 12 to 75 years; 3. Patients who meet the diagnostic criteria of CHC, and positive HCVRNA 4. Failed with standard of care and dont willing to accept SOC again; 5. Have the contraindication of SOC; 6. Cannot tolerate the side effects of SOC; 7. Not willing to or havre no economic capacity to accept SOC; 8. Separated into different groups with syndrome differentiation.

Exclusion criteria

Exclusion criteria: 1. Co-infection with HIV, HBV, HDV and other hepadnaviruses are excluded; 2. With chronic severe hepatitis, cirrhosis or liver cancer; 3. With severe primary cardiac,lung, kidney, blood, metabolism, gastrointestinal or affect the survival of serious diseases, or Mental disorders; 4. Pregnancy, breast-feeding women; 5. ALT>=5*ULN and/or TBIL>=3*ULN; 6. can not give fully informed consent.

Design outcomes

Primary

MeasureTime frame
HBV DNA virus load;

Secondary

MeasureTime frame
Liver function;ultrasonic B examination;Chronic liver disease instrument;clinical symptom;quality of life;

Countries

China

Contacts

Public ContactJianjie Chen
jianjie_chen@hotmai.com+86 13801872388

Outcome results

None listed

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