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Clinical Trials/NCT03189992
NCT03189992
Unknown
Phase 1

Study of "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" of Primary Hepatocellular Carcinoma and Colorectal Cancer Under the Perspective of System Science

Shanghai University of Traditional Chinese Medicine1 site in 1 country320 target enrollmentJanuary 2014

Overview

Phase
Phase 1
Intervention
Bushen-Jianpi Dedoction
Conditions
Malignant Tumor of Small Intestine Metastatic to Liver
Sponsor
Shanghai University of Traditional Chinese Medicine
Enrollment
320
Locations
1
Primary Endpoint
Complete patient recruitment
Last Updated
8 years ago

Overview

Brief Summary

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".

Detailed Description

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. 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

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shanghai University of Traditional Chinese Medicine
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

CC-GSYXZ

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

Intervention: Bushen-Jianpi Dedoction

CC-GSYXZ

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

Intervention: cinobufotalin injection

CC-WZ

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

Intervention: cinobufotalin injection

HCC-GSYXZ

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

Intervention: Bushen-Jianpi Dedoction

HCC-GSYXZ

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

Intervention: cinobufotalin injection

HCC-WZ

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

Intervention: cinobufotalin injection

Outcomes

Primary Outcomes

Complete patient recruitment

Time Frame: 24 months

Complete transcriptome microarray detection

Study Sites (1)

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