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Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)

Sponsor
Beijing Ditan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05088733
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV related hepatocellular carcinoma induced anemia. The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy for patients belong to HBV-HCC induced anemia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Yang Yin Fu Zheng Jie Du therapy
  • Other: Routine medical care
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Yang Yin Fu Zheng Jie Du therapy

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

Other: Routine medical care
Routine medical care
Placebo Comparator: Routine medical care

Other: Routine medical care
Routine medical care

Outcome Measures

Primary Outcome Measures

  1. Survival rate [1 year]

Secondary Outcome Measures

  1. Objective response rate [1 year]

  2. quality of life (QOL) questionnaire [1 year]

    The questionnaire includes appetite, sleep, fatigue, pain, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Meet the criteria of hepatocellular carcinoma

  • Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months

  • Meet the criteria of anemia

  • Ages Eligible for Study: ≤75 years old;

  • Informed consent from the patient.

Exclusion Criteria:

  • Patients with upper gastrointestinal bleeding within 3 months before enrollment;

  • History of blood transfusion within 3 months before enrollment;

  • Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;

  • Serious problem of heart, lung, or kidney with severe dysfunction;

  • Pregnant or child breast feeding women;

  • Mental or cognitive disorders;

  • Participating in other drug trials;

  • Who are allergic to the study drug.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhiyun Yang Beijing Beijing China 100015

Sponsors and Collaborators

  • Beijing Ditan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhiyun Yang, Archiater, Professor, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT05088733
Other Study ID Numbers:
  • BJDHYZY
First Posted:
Oct 22, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Nov 19, 2021