Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma

NCT ID: NCT02927626

Last Updated: 2020-07-10

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

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

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Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.

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 therapy

Group Type EXPERIMENTAL

Yang Yin Fu Zheng therapy

Intervention Type DRUG

Yang Yin Fu Zheng is a Chinese herbal compound.

Routine medical care

Intervention Type DRUG

Routine medical care

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 therapy

Yang Yin Fu Zheng 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

1. Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
2. Ages Eligible for Study: ≤75 years old;
3. TCM syndrome is deficiency of both Qi and Yin;
4. Confirmed of CHB;
5. Surgery cannot be allowed;
6. Informed consent from the patient.

Exclusion Criteria

1. Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
2. Serious problem of heart, lung, or kidney with severe dysfunction;
3. Pregnant or child breast feeding women;
4. Mental or cognitive disorders;
5. Participating in other drug trials;
6. Who are allergic to the study drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Principal Investigators

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Zhiyun Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

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Zhiyun Yang

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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BeijingDH

Identifier Type: -

Identifier Source: org_study_id

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