Back to resultsChinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms
Primary Purpose
Viral Haemorrhagic Fever, Dengue Fever
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Western Medicine
TCM and Western Medicine
Sponsored by
About this trial
This is an interventional treatment trial for Viral Haemorrhagic Fever
Eligibility 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
Sites / Locations
- Xi 'an eighth people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TCM and Western Medicine
Western Medicine
Arm Description
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
Western Medicine：Ribavirin 10-15mg per kg every time
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Safety outcome
With adverse events as the calculation basis
Full Information
NCT ID
NCT01973855
First Posted
October 24, 2013
Last Updated
October 31, 2013
Sponsor
Guangzhou 8th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01973855
Brief Title
Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou 8th People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Haemorrhagic Fever, Dengue Fever
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCM and Western Medicine
Arm Type
Experimental
Arm Description
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
Arm Title
Western Medicine
Arm Type
Placebo Comparator
Arm Description
Western Medicine：Ribavirin 10-15mg per kg every time
Intervention Type
Drug
Intervention Name(s)
Western Medicine
Other Intervention Name(s)
Ribavirin,
Intervention Description
Physical cooling,Hydrocortisone
Intervention Type
Drug
Intervention Name(s)
TCM and Western Medicine
Other Intervention Name(s)
Second Infectious diseases soup recipe and Ribavirin
Intervention Description
Third Infectious diseases soup recipe
Primary Outcome Measure Information:
Title
Mortality
Time Frame
Anytime of the clinical trail from 2011.1.1 to 2015.12.30
Secondary Outcome Measure Information:
Title
Safety outcome
Description
With adverse events as the calculation basis
Time Frame
From 2012.1 to 2015.12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan X Hua
Phone
13500039656
Email
Gz8htxh@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tan X Hua
Organizational Affiliation
Guangzhou 8th hospitol
Official's Role
Study Director
Facility Information:
Facility Name
Xi 'an eighth people's hospital
City
XiAn
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu R Fang
Phone
13008415052
Email
xurongfang@vip.sina.com
12. IPD Sharing Statement
Learn more about this trial
Chinese and Western Medicine Treatment of Fever Associated With Bleeding Symptoms
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