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Randomised controlled trial of Ruangan granules for HBV cirrhosis

Treatment of traditional Chinese medicine for HBV cirrhosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-15007567
Enrollment
Unknown
Registered
2015-07-25
Start date
2015-08-01
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

HBV cirrhosis

Interventions

Experimental Group:Ruangan capsule 100ml bid
Experimental Group:ETV0.5mg/d
Control Group:ETV0.5mg/d

Sponsors

Shenzhen Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. In accordance with the diagnostic criteria of HBV cirrhosis: (1) Serological diagnosis: HBsAg positive and HBV-DNA more than 2000U/L, HBeAg positive or negative; ALT more than 50U/L; (2) TCM diagnosis: According to the diagnosis and treatment protocol for active stage of the HBV cirrhosis (accumulation); (3) Liver pathology diagnosis S3; (4) Imaging score more than 8 point; (5) The hardness of liver fiber scanning more than 12.4 point; 2. In accordance with relevant Ruangan capsule Zheng.

Exclusion criteria

Exclusion criteria: 1. Cirrhosis patients with HBSAG (-); 2. Child score more than 7point; 3. Simultaneous infection with HIV/HCV/HDV; 4. Complicated by metabolic or autoimmune liver disease; 5. With abuse of alcohol or illicit drug history; Involved in other trials of hepatitis drugs within 30 days; 6. Mental illness and other serious organic diseases.

Design outcomes

Primary

MeasureTime frame
Ultrasonography scoring;Histology of liver biopsy;

Secondary

MeasureTime frame
Liver function;HBV quantity;Two pairs of semi-quantitative;

Countries

China

Contacts

Public ContactDaqiao Zhou

Guangdong Provincial Hospital of Chinese Medicine

zdqdoctor@sina.com+86 755 88359666

Outcome results

None listed

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