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Bicyclol Tablets for the hepatitis A virus: a double-blind, randomized, placebo-controlled trial

Bicyclol Tablets for the hepatitis A virus: a double-blind, randomized, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001231
Enrollment
Unknown
Registered
2011-03-15
Start date
2010-12-01
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

hepatitis A virus

Interventions

Group A:Bicyclol Tablets 50mg/b.i.d./day for adults and 1.5mg/kg/t.i.d./day for children, orally taken for 1 months
Group B:placebo orally taken twice daily for 1 months

Sponsors

The Affiliated Hospital of Guiyang Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 6 to 65 years old, male or female; 2. The diagnostic criteria meet "Hepatitis virus Control Programme"(Xi'an in 2000). positive serum of anti-HAV IgM of acute hepatitis patients can be diagnosed HAV recent infection; 3. The srum ALT (ULN) is above 1.5 ~ 15-fold of normal upper limit, while serum TBil less than at least 5*ULN; 4. Able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Associated with Other types of hepatitis viruses, or autoimmune liver disease and hereditary liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis; 2. The appearance of disfunction liver have one of the following indications serum albumin less than 30g/L; prothrombin activity less than 40%; Ascites, esophageal varices and a history of hepatic encephalopathy; jaundice Progressively deepening (serum total bilirubin more than 85.5 mol/L or a daily increase more than at least 17.1 mol/L); 3. Diagnosed cancer patients, renal insufficiency, myositis and other autoimmune diseases, and severe infections disease of other systems; 4. Pregnant or lactating women; 5. Combination with using other drugs of Protecting the liver cells and decreasing transaminase; 6. researchers believe that patients are not included in the study.

Design outcomes

Primary

MeasureTime frame
biochemical indices of liver function;

Countries

China

Contacts

Public ContactMingliang Cheng
chengml@21cn.com+86 13608596566

Outcome results

None listed

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