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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088733
• Other study ID #: BJDHYZY
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2021
• Source: Beijing Ditan Hospital
• Contact: Zhiyun Yang, doctor
• Phone: +8613439696988
• Email: 13439696988[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Zhiyun Yang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate		1 year
Secondary	Objective response rate		1 year
Secondary	quality of life (QOL) questionnaire	The questionnaire includes appetite, sleep, fatigue, pain, etc.	1 year