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Clinical Trials/NCT01973855
NCT01973855UnknownPhase 2

Syndrome of Fever Associated With Bleeding of Chinese and Western Medicine Diagnosis and Treatment of Infectious Diseases Plans and Severe Clinical Treatment Research

Guangzhou 8th People's Hospital1 site in 1 country300 target enrollmentStarted: January 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
Mortality

Study Overview

Brief Summary

To meet eligibility criteria, this study and informed consent of the syndrome of fever associated with bleeding of infectious diseases, severe patients to carry out multicenter, practical randomized controlled clinical research, to compare the curative effect of western medicine, combining Chinese and western medicine treatment, and security, and pathogenesis of TCM and syndrome, severe immune related factor and syndrome type of traditional Chinese medicine, Chinese medicine prescriptions mechanism research.

Detailed Description

Randomized method: using large sample, central randomized, parallel comparison of Chinese and western medicine and western medicine group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Viral diseases, such as dengue fever, kidney of hemorrhagic fever, such as xinjiang hemorrhagic fever; Or clinical has fever associated with bleeding as the main performance, and confirmed as the new emergent infectious diseases

Exclusion Criteria

  • Diagnosed with flu, hand, foot and mouth disease, viral hepatitis (except the carrier), liver cirrhosis after hepatitis, AIDS, rabies, encephalitis, polio, measles, German measles, chickenpox, herpes, infectious mononucleosis, infectious atypical pneumonia

Arms & Interventions

TCM and Western Medicine

Experimental

TCM and Western Medicine:First Infectious diseases soup recipe,every time a dose,Two times a day;Ribavirin 10-15mg per kg every time Western Medicine:Ribavirin 10-15mg per kg every time

Intervention: Western Medicine (Drug)

TCM and Western Medicine

Experimental

TCM and Western Medicine:First Infectious diseases soup recipe,every time a dose,Two times a day;Ribavirin 10-15mg per kg every time Western Medicine:Ribavirin 10-15mg per kg every time

Intervention: TCM and Western Medicine (Drug)

Western Medicine

Placebo Comparator

Western Medicine:Ribavirin 10-15mg per kg every time

Intervention: TCM and Western Medicine (Drug)

Outcomes

Primary Outcomes

Mortality

Time Frame: Anytime of the clinical trail from 2011.1.1 to 2015.12.30

Secondary Outcomes

  • Safety outcome(From 2012.1 to 2015.12)

Investigators

Sponsor
Guangzhou 8th People's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xinghua Tan

Director of Department of infection area

Guangzhou 8th People's Hospital

Study Sites (1)

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