Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms

October 31, 2013 updated by: Xinghua Tan, Guangzhou 8th People's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

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
    • Shanxi
      • XiAn, Shanxi, China, 710000
        • Recruiting
        • Xi 'an eighth people's hospital
        • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TCM and Western Medicine
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
Drug: Western Medicine
Physical cooling,Hydrocortisone
Other Names:
  • Ribavirin,
Drug: TCM and Western Medicine
Third Infectious diseases soup recipe
Other Names:
  • Second Infectious diseases soup recipe and Ribavirin
Placebo Comparator: Western Medicine
Western Medicine：Ribavirin 10-15mg per kg every time
Drug: TCM and Western Medicine
Third Infectious diseases soup recipe
Other Names:
  • Second Infectious diseases soup recipe and Ribavirin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcome
Time Frame: From 2012.1 to 2015.12
With adverse events as the calculation basis
From 2012.1 to 2015.12

Collaborators and Investigators

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

Sponsor

Guangzhou 8th People's Hospital

Investigators

  • Study Director: Tan X Hua, Guangzhou 8th hospitol

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, 2012

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012ZX10004301-003

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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