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

Fever of Unknown Origin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02695914
• Other study ID #: JJ2015-49
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 31, 2016
• Last updated: February 29, 2016
• Start date: January 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2016
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fever of Unknown Origin

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory marker (TREM-1) in patient of FUO		7th day	No
Secondary	Inflammatory marker (TNF) in patient of FUO		7th day	No
Secondary	Inflammatory marker (IL-1) in patient of FUO		7th day	No
Secondary	Inflammatory marker (IL-6) in patient of FUO		7th day	No