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A prospective, randomized, double-blind, placebo-controlled clinical trial on the use of "Fuzhengxiaoliu Patch" to intervene liver cancer pain (both the syndrome of interior retention of damp-heat and Syndrome of Poison and Blood Stasis Agglomeration)

A clinical evidence-based evaluation study on the treatment of liver cancer pain with "Fuzhengxiaoliu Patch" through transdermal administration

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076951
Enrollment
Unknown
Registered
2023-10-25
Start date
2023-10-30
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cancer pain

Interventions

Test group:Fuzhengxiaoliu Patch
Control group:placebo Fuzhengxiaoliu Patch

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) All patients meet the diagnostic criteria for liver cancer and have pain in the liver area. The pain pathological type belongs to somatic pain, and the cause of the cancer pain is directly related to liver cancer; (2) Chinese medicine syndrome differentiation is internal retention of damp-heat and Syndrome of Poison and Blood Stasis Agglomeration; (3) NRS score = 7 points; (4) Cancer staging belongs to stage IIb, IIIa patients who refuse surgery and other anti-tumor treatments, and stage IIIb, IV patients; (5) Patients who have received chemotherapy, targeted therapy, immunotherapy, etc., but have been evaluated as ineffective, or patients who refuse or cannot tolerate the above treatments for liver cancer; (6) ECOG score 0-3 points; (7) The skin at the site of application is intact; (8) Age = 18 years, = 75 years, with an expected survival time of more than 3 months; (9) Patients have given informed consent and signed an informed consent form. Patients who meet all the above inclusion criteria will be included.

Exclusion criteria

Exclusion criteria: (1) Abnormal blood ammonia level or platelet count 3 times the upper limit of normal reference value or aspartate aminotransferase > 3 times the upper limit of normal reference value; (2) Patients whose average NRS pain score in the three days prior to randomization is more than ±2 points higher than the fluctuation in the pain score before screening; (3) Patients with mental illness, poor compliance, or inability to independently assess and investigate pain; (4) Patients with serious primary diseases such as heart, lung, kidney, metabolism, immunity, nervous system, urinary system and hematopoietic system; (5) Patients with a history of serious drug allergies in the past, or patients who are allergic to the drugs and materials used in this trial; (6) Pregnant or breastfeeding women; (7) Subjects who are considered by the investigator to be inappropriate for participation in this clinical study. Patients who meet any of the above conditions will be excluded.

Design outcomes

Primary

MeasureTime frame
opioid usage;National Reemployment Service;pain relief rate;frequency of breakthrough pain;

Secondary

MeasureTime frame
Therapeutic effect on solid tumors;Tumor markers ;traditional Chinese medicine syndrome score;weight;Functional Assessment of Cancer Therapy-Hepatobiliary;Self-rating anxiety scale;

Countries

China

Contacts

Public ContactYan Bohua

Hospital of Chengdu University of Traditional Chinese Medicine

ybh612003@163.com+86 180 1152 1921

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026