NCT01973855

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

3.2 years

First QC Date

October 24, 2013

Last Update Submit

October 31, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Anytime of the clinical trail from 2011.1.1 to 2015.12.30

Secondary Outcomes (1)

  • Safety outcome

    From 2012.1 to 2015.12

Study Arms (2)

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

Drug: Western MedicineDrug: TCM and Western Medicine

Western Medicine

PLACEBO COMPARATOR

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

Drug: TCM and Western Medicine

Interventions

Physical cooling,Hydrocortisone

Also known as: Ribavirin,
TCM and Western Medicine

Third Infectious diseases soup recipe

Also known as: Second Infectious diseases soup recipe and Ribavirin
TCM and Western MedicineWestern Medicine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi 'an eighth people's hospital

XiAn, Shanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Fevers, ViralDengue

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesArbovirus InfectionsFlavivirus InfectionsFlaviviridae Infections

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Tan X Hua

    Guangzhou 8th hospitol

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of infection area

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 1, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations