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

NCT ID: NCT03189992

Last Updated: 2017-06-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-12-31

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

Conditions

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Malignant Tumor of Small Intestine Metastatic to Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Bushen-Jianpi Dedoction

Intervention Type DRUG

A traditional chinese medicine prescription

cinobufotalin injection

Intervention Type DRUG

an effective Chinese preparation to treat malignant tumor.

CC-WZ

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

Group Type PLACEBO_COMPARATOR

cinobufotalin injection

Intervention Type DRUG

an effective Chinese preparation to treat malignant tumor.

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.

Group Type EXPERIMENTAL

Bushen-Jianpi Dedoction

Intervention Type DRUG

A traditional chinese medicine prescription

cinobufotalin injection

Intervention Type DRUG

an effective Chinese preparation to treat malignant tumor.

HCC-WZ

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

Group Type PLACEBO_COMPARATOR

cinobufotalin injection

Intervention Type DRUG

an effective Chinese preparation to treat malignant tumor.

Interventions

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Bushen-Jianpi Dedoction

A traditional chinese medicine prescription

Intervention Type DRUG

cinobufotalin injection

an effective Chinese preparation to treat malignant tumor.

Intervention Type DRUG

Other Intervention Names

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BSJPD CI

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of primary liver cancer (HCC) and colorectal cancer after surgery.
2. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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shi bing su, PhD

Role: PRINCIPAL_INVESTIGATOR

Shuguang Hospital affiliated with Shanghai University of TCM

Locations

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Shang Hai TCM University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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shi bing su, Professor

Role: CONTACT

021-51323013

Facility Contacts

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shibing su

Role: primary

021-51323013

References

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Wang J, Hu Y, Zhao K, Fan J, Zhu J, Li Q, Chen Q, Lu Y. Comprehensive Analysis of the Expression of Cell Adhesion Molecules Genes in Hepatocellular Carcinoma and their Prognosis, and Biological Significance. Front Biosci (Landmark Ed). 2024 Feb 21;29(2):76. doi: 10.31083/j.fbl2902076.

Reference Type DERIVED
PMID: 38420809 (View on PubMed)

Chen J, Chen QL, Wang WH, Chen XL, Hu XQ, Liang ZQ, Cao YB, Cao YM, Su SB. Prognostic and predictive values of CXCL10 in colorectal cancer. Clin Transl Oncol. 2020 Sep;22(9):1548-1564. doi: 10.1007/s12094-020-02299-6. Epub 2020 Feb 3.

Reference Type DERIVED
PMID: 32016676 (View on PubMed)

Lu Y, Fang Z, Zeng T, Li M, Chen Q, Zhang H, Zhou Q, Hu Y, Chen L, Su S. Chronic hepatitis B: dynamic change in Traditional Chinese Medicine syndrome by dynamic network biomarkers. Chin Med. 2019 Nov 21;14:52. doi: 10.1186/s13020-019-0275-4. eCollection 2019.

Reference Type DERIVED
PMID: 31768187 (View on PubMed)

Other Identifiers

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ShanghaiUTCM

Identifier Type: -

Identifier Source: org_study_id

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