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Clinical Study on the Combination Therapy of Yuganling Mixture and Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

Clinical Study on the Combination Therapy of Yuganling Mixture and Tenofovir Disoproxil Fumarate for Chronic Hepatitis B

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001666
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-03-14
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Chronic Hepatitis B

Interventions

Control:TDF treatment for 12 weeks
Treatment:Yuganling Mixture combination combined with TDF treatment for 12 weeks

Sponsors

The Fourth Peoples Hospital of Huaian
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the western medical diagnostic criteria for CHB and refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) formulated by the Hepatology Branch and Infectious Diseases Branch of the Chinese Medical Association to formulate the diagnostic criteria for CHB. 2. Meet the Chinese traditional medicine identification criteria for CHB and refer to the Expert Consensus on Integrated Chinese and Western Medicine Diagnosis and Treatment of Chronic Hepatitis B (2024 Edition) formulated by the Hepatology Expert Committee of Chinese and Western Medicine Combined Medical Practitioners Branch of Chinese Medical Doctors' Association to formulate the identification criteria for CHB with liver-gallbladder and damp-heat syndrome. Primary symptoms: (1) distension and pain in the abdomen and ribs; (2) red tongue with yellowish fur. Secondary symptoms: dullness and vomiting aversion to oil and grease; sticky and foul-smelling stools; yellow urine; yellow body and eyes. Requirements for identification: (1) The syndrome is defined as having two of all the primary symptoms; (2) The syndrome is defined as having one of the primary symptoms plus two of the secondary symptoms. 3. Age 18-65 years old regardless of gender. 4. CHB patients with non-cirrhotic decompensated liver disease who have not received treatment or who have discontinued nucleotide analog therapy for at least 6 months or interferon for at least 1 year before screening. 5. HBV DNA of patients with HBeAg-negative disease =2×104 IU/kg and HBV DNA of patients with HBV DNA =2×104 IU/kg; ALT less than 5 times the upper limit of normal. 6. Informed consent and signing of an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with other chronic viral hepatitis hepatocellular carcinoma hepatic encephalopathy or cardiovascular hepatic renal hematopoietic system and other serious diseases psychiatric patients; 2. Patients who are allergic to allergy or allergic to the known components of this drug or other drugs history of drug liver damage; 3. Pregnant women lactating women and women who are preparing for pregnancy; 4. Patients with immunodeficiency.

Design outcomes

Primary

MeasureTime frame
Hepatitis B virus DNA level;Traditional Chinese medicine syndrome scores;

Secondary

MeasureTime frame
Plasma Prothrombin Time Activity;Prealbumin;Hepatitis B e antigen level;Aspartate aminotransferase;Alkaline phosphatase;Gamma-glutamyltransferase;Alanine aminotransferase;

Countries

China

Contacts

Public ContactWang Yulu

The Fourth Peoples Hospital of Huaian

yuluwang530@163.com15861799196

Outcome results

None listed

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