Influence of Compound Qingre Granule on the Inflammatory Markers in Patient of FUO With Excess-heat Syndrome

• Conditions: Fever of Unknown Origin
• Interventions: Drug: Compound Qingre Granule

• Registration Number: NCT02695914
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

All the cases will be provided by the Infectious Diseases Department of Beijing Friendship Hospital.Each patient should sign informed consent. Assessing the accuracy, completeness, or representativeness of registry data by comparing the data to medical records. After collecting, sorting and entering the data, reducing the missing value, and then checking into the database.

The stochastic indicator method will be used to simple random sampling, to ensure the probabilities of each individuals be given Chinese medicine intervention are equal.Operations must be standard to reduce errors.

Quality assurance plan: Patient of fever within two weeks, or whose temperature is below 38.5 degree centigrade will be excluded. The registration form includes the following parts: Name, sex, age, address, phone number, admission time, primary diagnoses and levels of Inflammatory markers.

Data will be analyzed using the SPSS17.0 (Statistical Product and Service Solutions 17.0) statistical software. Difference of measurement data will be compared with analysis of variance,and difference of enumeration data will be compared with rank-sum test.P\<0.05 has statistical significance.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-31
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Study First Posted: 2016-03-01
• Last Update Posted: 2016-03-01
• Primary Completion: 2017-04
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patient of fever of unknown origin (FUO).

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Inflammatory marker (TREM-1) in patient of FUO	7th day

Secondary Outcome Measures

Name	Time	Method
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