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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02695914

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fever of Unknown Origin	Drug: Compound Qingre Granule

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 A kind of Chinese patent medicine, which is developed by Dr.Shuwen Zhang and Dr.Baoen Wang from Beijing Friendship Hospital. Other Names: Fufang Qingre Keli

Arm

Intervention/Treatment

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

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

Other Names:

Fufang Qingre Keli

Outcome Measures

Primary Outcome Measures

Inflammatory marker (TREM-1) in patient of FUO [7th day]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

Study Director: Chao Wang, Doctor, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Miao Shi, postgraduate, Beijing Friendship Hospital

ClinicalTrials.gov Identifier:

NCT02695914

Other Study ID Numbers:

JJ2015-49

First Posted:

Mar 1, 2016

Last Update Posted:

Mar 1, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Miao Shi, postgraduate, Beijing Friendship Hospital

Inflammatory markers

Additional relevant MeSH terms:

Fever of Unknown Origin

Study Results

No Results Posted as of Mar 1, 2016