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

February 29, 2016 updated by: Miao Shi, Beijing Friendship Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient of fever of unknown origin with excess-heat syndrome

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inflammatory marker (TREM-1) in patient of FUO
Time Frame: 7th day
7th day

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory marker (TNF) in patient of FUO
Time Frame: 7th day
7th day
Inflammatory marker (IL-1) in patient of FUO
Time Frame: 7th day
7th day
Inflammatory marker (IL-6) in patient of FUO
Time Frame: 7th day
7th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Director: Chao Wang, Doctor, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

January 31, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJ2015-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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