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

Primary Purpose

Malignant Tumor of Small Intestine Metastatic to Liver

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Bushen-Jianpi Dedoction
cinobufotalin injection
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Tumor of Small Intestine Metastatic to Liver

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shang Hai TCM UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

CC-GSYXZ

CC-WZ

HCC-GSYXZ

HCC-WZ

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Complete patient recruitment
Complete transcriptome microarray detection

Secondary Outcome Measures

Full Information

First Posted
June 4, 2017
Last Updated
June 15, 2017
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03189992
Brief Title
Study of TCM Syndrome of Hepatocellular Carcinoma and Colorectal Cancer Based on System Science
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Tumor of Small Intestine Metastatic to Liver

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CC-GSYXZ
Arm Type
Experimental
Arm Description
Colon cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection
Arm Title
CC-WZ
Arm Type
Placebo Comparator
Arm Description
Colon cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection
Arm Title
HCC-GSYXZ
Arm Type
Experimental
Arm Description
Hepatoma cancer with Chinese medicine syndrome Yin deficiency of liver and kidney and spleen deficiency.Intervented by Bushen-Jianpi Dedoction and cinobufotalin injection.
Arm Title
HCC-WZ
Arm Type
Placebo Comparator
Arm Description
Hepatoma cancer with none Chinese medicine syndrome.Intervented by cinobufotalin injection
Intervention Type
Drug
Intervention Name(s)
Bushen-Jianpi Dedoction
Other Intervention Name(s)
BSJPD
Intervention Description
A traditional chinese medicine prescription
Intervention Type
Drug
Intervention Name(s)
cinobufotalin injection
Other Intervention Name(s)
CI
Intervention Description
an effective Chinese preparation to treat malignant tumor.
Primary Outcome Measure Information:
Title
Complete patient recruitment
Description
Complete transcriptome microarray detection
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shi bing su, Professor
Phone
021-51323013
Email
shibingsu07@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shi bing su, PhD
Organizational Affiliation
Shuguang Hospital affiliated with Shanghai University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shang Hai TCM University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shibing su
Phone
021-51323013
Email
shibingsu07@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32016676
Citation
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.
Results Reference
derived
PubMed Identifier
31768187
Citation
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.
Results Reference
derived

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

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