Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization
1 other identifier
interventional
60
1 country
1
Brief Summary
Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedSeptember 17, 2025
September 1, 2025
3 years
April 28, 2023
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Changes of serum Aspartate Transaminase (AST) level after TACE
The serum Aspartate Transaminase (AST) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
28 days
Changes of serum Alanine Aminotransferase (ALT) level after TACE
The serum Alanine Aminotransferase (ALT) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.
28 days
Changes of serum total bilirubin level after TACE
The serum total bilirubin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
28 days
Changes of serum albumin level after TACE
The serum albumin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline
28 days
Changes of prothrombin time after TACE
The prothrombin time after TACE day 1, day 3, day 7, and day 28 are compared to the baseline.
28 days
Secondary Outcomes (1)
Improvement of the quality of life
28 days
Study Arms (2)
Antrodia cinnamomea group
EXPERIMENTALThis group will use Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage form of Antrodia cinnamomea is single capsule/500mg, each oral dose is 2 capsules/1000mg. The experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.
Placebo group
PLACEBO COMPARATORThis group will use placebo on the hepatoma patients after Transcatheter hepatic artery chemoembolization. The choice of chemical drug dosage for the patient's hepatic artery embolization is evaluated according to the size of the tumor, which can be divided into 1. Epirubicin 10mg + Lipiodol 10ml 2. Epirubicin 20mg + Lipiodol 10ml; oral dosage of placebo is 2 capsules twice daily. The experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.
Interventions
The experiment lasted for 11 days, and patients were required to take Kangjian Antrodia cinnamomea 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.
The experiment lasted for 11 days, and patients were required to take placebo 3 days before embolization, the day of embolization to the 7th day after surgery, once a day in the morning and evening after meals, 2 capsules each time.
Eligibility Criteria
You may qualify if:
- Sign the informed consent form
- Aged between 20 and 80
- Child-Pugh score class A, B
- Serum bilirubin level ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2 times the upper limit of normal
You may not qualify if:
- Unwillingness to sign the informed consent form
- Child-Pugh score class C
- Patients with main portal vein thrombosis
- Patients with diffuse liver tumors
- Those who are allergic to the contrast medium
- Those with abnormal coagulation function
- Those with severe dysfunction of brain, heart and lung
- Patients with severe renal dysfunction (except those receiving renal dialysis)
- Unable to cooperate
- Those with uncontrolled arrhythmia and unstable blood pressure
- Some patients with abnormal thyroid function
- Any other contraindications such as active gastrointestinal bleeding, refractory ascites, or severe portal hypertension
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taichung Tzu-Chi Hospital
Taichung, Taiwan, 406, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 28, 2023
First Posted
September 17, 2025
Study Start
January 1, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share