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

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ClinicalTrials.gov Identifier: NCT03189992
Recruitment Status : Unknown
Verified March 2017 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

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".


Condition or disease Intervention/treatment Phase
Malignant Tumor of Small Intestine Metastatic to Liver Drug: Bushen-Jianpi Dedoction Drug: cinobufotalin injection Phase 1

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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 Start Date : January 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: BSJPD

Drug: cinobufotalin injection
an effective Chinese preparation to treat malignant tumor.
Other Name: 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 Name: 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 Name: BSJPD

Drug: cinobufotalin injection
an effective Chinese preparation to treat malignant tumor.
Other Name: 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 Name: CI




Primary Outcome Measures :
  1. Complete patient recruitment [ Time Frame: 24 months ]
    Complete transcriptome microarray detection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189992


Contacts
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Contact: shi bing su, Professor 021-51323013 shibingsu07@163.com

Locations
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China
Shang Hai TCM University Recruiting
Shanghai, China
Contact: shibing su    021-51323013    shibingsu07@163.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Principal Investigator: shi bing su, PhD Shuguang Hospital affiliated with Shanghai University of TCM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03189992     History of Changes
Other Study ID Numbers: ShanghaiUTCM
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Liver Diseases