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

June 15, 2017 updated by: Shanghai University of Traditional Chinese Medicine

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

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".

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shang Hai TCM University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: Bushen-Jianpi Dedoction
A traditional chinese medicine prescription
Other Names:
  • BSJPD
Drug: cinobufotalin injection
an effective Chinese preparation to treat malignant tumor.
Other Names:
  • CI
PLACEBO_COMPARATOR: CC-WZ
Colon cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection
Drug: cinobufotalin injection
an effective Chinese preparation to treat malignant tumor.
Other Names:
  • CI
EXPERIMENTAL: 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.
Drug: Bushen-Jianpi Dedoction
A traditional chinese medicine prescription
Other Names:
  • BSJPD
Drug: cinobufotalin injection
an effective Chinese preparation to treat malignant tumor.
Other Names:
  • CI
PLACEBO_COMPARATOR: HCC-WZ
Hepatoma cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection
Drug: cinobufotalin injection
an effective Chinese preparation to treat malignant tumor.
Other Names:
  • CI

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: shi bing su, PhD, Shuguang Hospital Affiliated with Shanghai University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

June 4, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (ACTUAL)

June 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiUTCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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