NCT02695914

Brief Summary

The purpose of this study is to observe inflammatory markers like TNF (tumor necrosis factor), IL-1 (interleukin-1), IL-6 (interleukin-6),TREM-1 (triggering receptor expressed on myeloid cells-1), etc, in patient of FUO with excess-heat syndrome and the influence of Compound Qingre Granule on the inflammatory markers.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

January 31, 2016

Last Update Submit

February 29, 2016

Conditions

Fever of Unknown Origin

Keywords

Inflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Inflammatory marker (TREM-1) in patient of FUO

    7th day

Secondary Outcomes (3)

  • Inflammatory marker (TNF) in patient of FUO

    7th day

  • Inflammatory marker (IL-1) in patient of FUO

    7th day

  • Inflammatory marker (IL-6) in patient of FUO

    7th day

Study Arms (2)

Control group

Conventional treatment methods will be given to cases in control group.

Experiment group

On the base of control group, Compound Qingre Granule will be added to in experiment group.

Drug: Compound Qingre Granule

Interventions

Compound Qingre GranuleDRUG

A kind of Chinese patent medicine, which is developed by Dr.Shuwen Zhang and Dr.Baoen Wang from Beijing Friendship Hospital.

Also known as: Fufang Qingre Keli
Experiment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient of fever of unknown origin with excess-heat syndrome

You may qualify if:

  • Patient of fever of unknown origin (FUO).

You may not qualify if:

  • Patient of fever within two weeks, or whose temperature is below 38.5 degree centigrade.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exsanguinating and saving the blood in the refrigerator of -4 ℃.

MeSH Terms

Conditions

Fever of Unknown Origin

Condition Hierarchy (Ancestors)

FeverBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chao Wang, Doctor

    Beijing Friendship Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate

Study Record Dates

First Submitted

January 31, 2016

First Posted

March 1, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

October 1, 2017

Last Updated

March 1, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share