Fever of Unknown OriginNCT02695914
Influence of Compound Qingre Granule on the Inflammatory Markers in Patient of FUO With Excess-heat Syndrome
An observational study of Fever of Unknown Origin, run by Beijing Friendship Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fever of Unknown Origin
- What is being tested?
- Compound Qingre Granule
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient of fever of unknown origin with excess-heat syndrome
Who may be able to join
- Patient of fever of unknown origin (FUO).
Who cannot join
- Patient of fever within two weeks, or whose temperature is below 38.5 degree centigrade.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fever of Unknown Origin
- Being tested
- Compound Qingre Granule
- Keywords
- Inflammatory markers
- Medical subject headings
- Fever of Unknown Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Qingre GranuleDrug
Also called Fufang Qingre Keli
A kind of Chinese patent medicine, which is developed by Dr.Shuwen Zhang and Dr.Baoen Wang from Beijing Friendship Hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Compound Qingre Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory marker (TREM-1) in patient of FUO
Measured: 7th day
Secondary outcomes (3)
Inflammatory marker (TNF) in patient of FUO
Measured: 7th day
Inflammatory marker (IL-1) in patient of FUO
Measured: 7th day
Inflammatory marker (IL-6) in patient of FUO
Measured: 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fever of Unknown OriginStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miao Shi, Beijing Friendship Hospital
- Investigators
- Chao Wang, Doctor, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695914
- Sponsor's protocol ID
- JJ2015-49
- Status last verified
- Feb 2016
- First submitted
- 31 Jan 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers in Patient of FUO With Excess-heat Syndrome and the Influence of Compound Qingre Granule on the Inflammatory Markers
- ClinicalTrials.gov ID
- NCT02695914
- Acronym / sponsor ID
- JJ2015-49
- Conditions
- Fever of Unknown Origin
- Keywords
- Inflammatory markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Conventional treatment methods will be given to cases in control group. |
| Experiment group | – | Drug: Compound Qingre GranuleOn the base of control group, Compound Qingre Granule will be added to in experiment group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient of fever of unknown origin with excess-heat syndrome
Key inclusion criteria (1 listed)
- Patient of fever of unknown origin (FUO).
Key exclusion criteria (1 listed)
- Patient of fever within two weeks, or whose temperature is below 38.5 degree centigrade.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Qingre GranuleAlso: Fufang Qingre KeliA kind of Chinese patent medicine, which is developed by Dr.Shuwen Zhang and Dr.Baoen Wang from Beijing Friendship Hospital. | Drug | Experiment group |
Primary outcome
Inflammatory marker (TREM-1) in patient of FUO
Time frame: 7th day
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Wang, Doctor study director
Beijing Friendship Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Fever of Unknown Origin, run by Beijing Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory marker (TREM-1) in patient of FUO (time frame: 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.