Study of TCM Syndrome of Hepatocellular Carcinoma and Colorectal Cancer Based on System Science

Shanghai University of Traditional Chinese Medicine

Status and phase

Unknown

Phase 1

Conditions

Malignant Tumor of Small Intestine Metastatic to Liver

Treatments

Drug: cinobufotalin injection

Drug: Bushen-Jianpi Dedoction

Study type

Interventional

Funder types

Other

Identifiers

NCT03189992

ShanghaiUTCM

Details and patient eligibility

About

Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge, clinical diagnosis and treatment and curative effect evaluation in TCM. "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" is one of the characteristics of TCM syndrome differentiation and treatment.

This study is the "TCM disease syndrome combination" research baced on principles and methods of system biology, which is through acquisition of primary hepatocellular carcinoma (HCC) and colorectal cancer patients with TCM syndrome information, detection of clinical indicators and genomic, proteomic, and metabolites changes, analyzing the correlation between TCM syndromes and biological information, and revealing its biological material characteristics and the molecular mechanisms of "Same TCM Syndrome for Different Diseases";Developing and implementing the program of TCM syndrome differentiation and treatment for HCC and colorectal cancer to evaluate the efficacy of TCM syndrome based-treatment of HCC and colorectal cancer with TCM syndrom scores, clinical and systems biological indicators, quality of life and survival rate, and to revealing the mechanism of the "Same Treatment for Different Diseases".

Full description

In this study, the investigators adopted the transcriptome analysis, proteome analysis and metabolic diversity analysis of the patients with different syndromes of liver cancer and colorectal cancer, and integrate omics information, combining macro and micro methods to screen biomarkers of syndromes

Enrollment

320 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of primary liver cancer (HCC) and colorectal cancer after surgery.
Liver cancer and colorectal cancer liver and kidney yin deficiency and spleen qi deficiency syndrome diagnosis standard : Yin deficiency of liver and kidney and spleen qi deficiency syndrome see hypochondriac pain, waist and knee Limp, fever, night sweats, dry mouth and throat, fatigue, anorexia, abdominal distension after eating more, red or pale tongue, less moss or Light peel, pulse fine.

Exclusion criteria

(1) there is a serious heart, kidney, and other diseases of the hematopoietic system effect of drug evaluation factors; (2)Mental disorders (3)Digestive tract obstruction; (4) poor compliance.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

320 participants in 4 patient groups, including a placebo group

CC-GSYXZ

Experimental group

Description:

Colon cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection

Treatment:

Drug: Bushen-Jianpi Dedoction

Drug: cinobufotalin injection

CC-WZ

Placebo Comparator group

Description:

Colon cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection

Treatment:

Drug: cinobufotalin injection

HCC-GSYXZ

Experimental group

Description:

Hepatoma cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection.

Treatment:

Drug: Bushen-Jianpi Dedoction

Drug: cinobufotalin injection

HCC-WZ

Placebo Comparator group

Description:

Hepatoma cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection

Treatment:

Drug: cinobufotalin injection