Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms

Dengue Fever Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973855
• Other study ID #: 2012ZX10004301-003
• Status: Recruiting
• Phase: Phase 2
• First received: October 24, 2013
• Last updated: October 31, 2013
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2013
• Source: Guangzhou 8th People's Hospital
• Contact: Tan X Hua
• Phone: 13500039656
• Email: Gz8htxh[@]126.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Fever
• Viral Haemorrhagic Fever

Intervention

Drug:
• Western Medicine
Physical cooling,Hydrocortisone
• TCM and Western Medicine
Third Infectious diseases soup recipe

Locations

Country	Name	City	State
China	Xi 'an eighth people's hospital	XiAn	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Anytime of the clinical trail from 2011.1.1 to 2015.12.30	Yes
Secondary	Safety outcome	With adverse events as the calculation basis	From 2012.1 to 2015.12	Yes