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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Malignant Tumor of Small Intestine Metastatic to Liver

Intervention / Treatment
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* Drug: Bushen-Jianpi Dedoction
* Drug: cinobufotalin injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-GSYXZ<br>Colon cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection | Drug: Bushen-Jianpi Dedoction<br>* A traditional chinese medicine prescription<br>* Other names: BSJPD;Drug: cinobufotalin injection<br>* an effective Chinese preparation to treat malignant tumor.<br>* Other names: CI;|
| Placebo Comparator: CC-WZ<br>Colon cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection | Drug: cinobufotalin injection<br>* an effective Chinese preparation to treat malignant tumor.<br>* Other names: CI;|
| Experimental: HCC-GSYXZ<br>Hepatoma cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection. | Drug: Bushen-Jianpi Dedoction<br>* A traditional chinese medicine prescription<br>* Other names: BSJPD;Drug: cinobufotalin injection<br>* an effective Chinese preparation to treat malignant tumor.<br>* Other names: CI;|
| Placebo Comparator: HCC-WZ<br>Hepatoma cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection | Drug: cinobufotalin injection<br>* an effective Chinese preparation to treat malignant tumor.<br>* Other names: CI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete patient recruitment | Complete transcriptome microarray detection | 24 months |