Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms

This study is currently recruiting participants.
Verified October 2013 by Guangzhou 8th People's Hospital
Sponsor:
Information provided by (Responsible Party):
Xinghua Tan, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier:
NCT01973855
First received: October 24, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Viral Haemorrhagic Fever
Dengue Fever
Drug: Western Medicine
Drug: TCM and Western Medicine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Syndrome of Fever Associated With Bleeding of Chinese and Western Medicine Diagnosis and Treatment of Infectious Diseases Plans and Severe Clinical Treatment Research

Resource links provided by NLM:


Further study details as provided by Guangzhou 8th People's Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: Anytime of the clinical trail from 2011.1.1 to 2015.12.30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety outcome [ Time Frame: From 2012.1 to 2015.12 ] [ Designated as safety issue: Yes ]
    With adverse events as the calculation basis


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ribavirin,
Drug: TCM and Western Medicine
Third Infectious diseases soup recipe
Other Name: 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 Name: Second Infectious diseases soup recipe and Ribavirin

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01973855

Contacts
Contact: Tan X Hua 13500039656 Gz8htxh@126.com

Locations
China, Shanxi
Xi 'an eighth people's hospital Recruiting
XiAn, Shanxi, China, 710000
Contact: Xu R Fang    13008415052    xurongfang@vip.sina.com   
Sponsors and Collaborators
Guangzhou 8th People's Hospital
Investigators
Study Director: Tan X Hua Guangzhou 8th hospitol
  More Information

No publications provided

Responsible Party: Xinghua Tan, Director of Department of infection area, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT01973855     History of Changes
Other Study ID Numbers: 2012ZX10004301-003
Study First Received: October 24, 2013
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dengue Hemorrhagic Fever
Hemorrhagic Fevers, Viral
Dengue
Fever
Hemorrhage
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014