Skip to content

Clinical study of Qizhuo Ruogan Granule in treating hepatic fibrosis of chronic viral hepatitis B

Clinical study of Qizhuo Ruogan Granule in treating hepatic fibrosis of chronic viral hepatitis B

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000420
Enrollment
Unknown
Registered
2024-09-11
Start date
2024-05-28
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Chronic hepatitis B liver fibrosis

Interventions

Experimental group:Antiviral drug combined with Qizhu Ruogan Granule Qizhu Ruogan granule was prepared by the Pharmacy Department of Affiliated Hospital of Chengdu University of Traditional Chinese Me
Control group:Antiviral drug combined with Fuzheng Huayu capsule, Fuzheng Huayu capsule (Shanghai Huanghai Pharmaceutical Co., LTD., SinopOD Z20020074, specification: 0.5g/ pill), oral, 1.5g/ time, 3

Sponsors

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of the Chronic Hepatitis B Prevention and Treatment Guidelines (2022); A history of hepatitis B or acute hepatitis B disease course more than 6 months did not heal; HBV surface antigen positive and HBV DNA positive; 3) May have fatigue appetite loss abdominal distension and other clinical symptoms; 4) Hepatic histological examination showed hepatitis lesions. 5) Ultrasound examination liver echo thickening and other changes. (2) In line with the diagnostic criteria of Integrated Chinese and Western Medicine Diagnosis and Treatment Guide for Liver Fibrosis (2019); Elevated LSM value measured by Fibroscan: ALT < 2×ULN: 9.4Kpa < LSM=17.0Kpa; ALT normal: 7.2Kpa < LSM=12.0Kpa. (3) It meets the criteria of syndrome differentiation and belongs to the diagnosis criteria of hypochondriac pain - Qi deficiency and blood stasis; (4) Voluntarily participate in this study and comply with the requirements of the research program; (5) Currently taking antiviral drugs; (6) HBVDNA<1000IU/ml.

Exclusion criteria

Exclusion criteria: (1) Cirrhosis liver failure hepatic encephalopathy and other serious complications; (2) combined with A C D E and other virus infection; (3) Complicated with serious primary diseases of the heart lung brain kidney and blood system; (4) alcoholic drug-induced autoimmune hepatitis caused by other causes (except hepatitis B); (5) Allergic to the drugs used in this program; (6) Pregnant pregnant lactating women and abnormal mental behavior; (7) Patients who take other anti-fibrosis drugs orally or add other Chinese medicine compounds or formulas during the course of treatment; (8) Abnormal bilirubin (between 1.71-17.1umol/L in the normal range); (9) ALT>2ULN.

Design outcomes

Primary

MeasureTime frame
liver stiffness measurement;

Countries

China

Contacts

Public ContactLi Hui

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

1400124746@qq.com18980880162

Outcome results

None listed

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