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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03189992
Other study ID # ShanghaiUTCM
Secondary ID
Status Recruiting
Phase Phase 1
First received June 4, 2017
Last updated June 15, 2017
Start date January 2014
Est. completion date December 2018

Study information

Verified date March 2017
Source Shanghai University of Traditional Chinese Medicine
Contact shi bing su, Professor
Phone 021-51323013
Email shibingsu07@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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".


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


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date December 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Bushen-Jianpi Dedoction
A traditional chinese medicine prescription
cinobufotalin injection
an effective Chinese preparation to treat malignant tumor.

Locations

Country Name City State
China Shang Hai TCM University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete patient recruitment Complete transcriptome microarray detection 24 months