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Yang Yin Fu Zheng Jie Du Therapy in HBV Associated Hepatocellular Carcinoma Based on the Platelet Count/Splenic Length-Diameter Ratio

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Capital Medical University

Status and phase

Unknown
Early Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Yang Yin Fu Zheng Jie Du therapy
Drug: Routine medical care

Study type

Interventional

Funder types

Other

Identifiers

NCT05154812
BJDH-YZY

Details and patient eligibility

About

Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV associated Hepatocellular Carcinoma based on the platelet count/splenic length-diameter ratio.The purpose of this study is to establish the efficacy evaluation system combined with platelet/splenic length-diameter ratio, and to clarify the effect of this method on relieving hepatitis B cirrhosis and delaying the progression of Hepatocellular Carcinoma.

Enrollment

108 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Meet the criteria of hepatocellular carcinoma Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months Liver function grade child-Pugh A/B Patients who have agreed to select local treatment according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2017) TCM syndrome differentiation belongs to deficiency of qi and Yin, stasis and toxin accumulation syndrom Informed consent from the patient.

Exclusion criteria

Patient with other hepatitis virus infections or alcoholic liver, autoimmunity liver, primary biliary cirrhosis, genetic metabolic liver disease, and previous liver transplantation; Serious problem of heart, lung, brain, blood and other important organs; Patients with metastatic liver cancer; Pregnant or child breast feeding women; Mental or cognitive disorders; Who are allergic to the study drug.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 2 patient groups, including a placebo group

Yang Yin Fu Zheng Jie Du therapy
Experimental group
Treatment:
Drug: Yang Yin Fu Zheng Jie Du therapy
Routine medical care
Placebo Comparator group
Treatment:
Drug: Routine medical care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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