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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

NCT ID: NCT05154812

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yang Yin Fu Zheng Jie Du therapy

Group Type EXPERIMENTAL

Yang Yin Fu Zheng Jie Du therapy

Intervention Type DRUG

Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.

Routine medical care

Group Type PLACEBO_COMPARATOR

Routine medical care

Intervention Type DRUG

Routine medical care

Interventions

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Yang Yin Fu Zheng Jie Du therapy

Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.

Intervention Type DRUG

Routine medical care

Routine medical care

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhiyun Yang

Archiater, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhiyun Yang, doctor

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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BJDH-YZY

Identifier Type: -

Identifier Source: org_study_id