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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

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 Summary:

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.


Sponsor: Beijing Friendship Hospital

Current Primary Outcome: Inflammatory marker (TREM-1) in patient of FUO [ Time Frame: 7th day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Inflammatory marker (TNF) in patient of FUO [ Time Frame: 7th day ]
  • Inflammatory marker (IL-1) in patient of FUO [ Time Frame: 7th day ]
  • Inflammatory marker (IL-6) in patient of FUO [ Time Frame: 7th day ]


Original Secondary Outcome: Same as current

Information By: Beijing Friendship Hospital

Dates:
Date Received: January 31, 2016
Date Started: January 2016
Date Completion: October 2017
Last Updated: February 29, 2016
Last Verified: February 2016