Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization
NCT ID: NCT07178093
Last Updated: 2025-09-17
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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Detailed Description
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Antrodia cinnamomea (AC) is a medicinal fungal species that has been widely used as a healthy food in Taiwan for the treatment of diverse health-related conditions, in recognition of its anticancer, hepatoprotective, anti-inflammatory, antidiabetic and neuroprotective activities. The properties of antitumor and hepatoprotective make A. cinnamomea extract or its major compounds an ideal candidate for enhancing the treatment effect for HCC.
Many cancer patients in Taiwan took Antrodia cinnamomea products during the course of therapies. In this study, we want to elucidate the effect of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization, such as the improvement of post-TACE syndrome ( liver function impairment, fever, nausea, and abdominal pain), the quality of life, and hospital stay, etc.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Antrodia cinnamomea group
This 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.
Antrodia cinnamomea
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
This 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.
placebo
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
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Antrodia cinnamomea
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Taichung Tzu Chi Hospital
OTHER
Responsible Party
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Yu, Cheng-Chan
Principal Investigator
Locations
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Taichung Tzu-Chi Hospital
Taichung, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REC111-54
Identifier Type: -
Identifier Source: org_study_id
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