Protein; DiseaseNCT04472754
The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study
An observational study of Protein; Disease, run by Guangzhou University of Traditional Chinese Medicine.
Trial summary
This study aimed to explorie the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Protein; Disease
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 30 Jun 2021
- How long will I take part?
- 1 Year
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population are people who diagnosed as ischemic stroke at Guangdong Provincial Hospital of Chinese Medicine The healthy volunteers are definted as people who have no history of cerebrovascular diseases (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.)
Who may be able to join
- Clinical diagnosis of ischemic stroke
- Aged 35-80-year-old.
- Agree to participate in clinical research and sign informed consent.
Who cannot join
- Clinical diagnosis of cerebral hemorrhage;
- With severe infection, severe renal dysfunction, and tumor;
- Clinical diagnosis of acute oral inflammation, oral ulcers, or urinary infections;
- Clinical diagnosis of systemic lupus erythematosus and rheumatoid arthritis;
- Pregnant women or lactating mothers
About this study
This study aimed to explorie the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.
Read the detailed description
Stroke is the disease with the highest mortality and disability in China, and the annual incidence of ischemic stroke is the highest. Atherosclerosis is the main cause of ischemic stroke. According to the theory of traditional Chinese medicine, the disease is closely related to the physical constitution of the individual. The main body constitution of the population in Lingnan area is phlegm dampness syndrome;Previous large cross-sectional studies have found that 65.3% of patients with ischemic stroke in Lingnan area have phlegm dampness syndrome. However, there is currently no biological evidence related to phlegm-dampness syndrome and ischemic stroke.In recent years, proteomics research technology has developed vigorously. The research samples have developed from blood obtained from minimally invasive to urine and saliva obtained non-invasively. Studies have found that urine proteins associated with AS include type I, type III collagen, 8-isoprostaglandin F2α, and saliva proteins include IL-1β, IL-6, TNF-α, and PGE2.Therefore, this research is dedicated to exploring the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.
- Conditions
- Protein; Disease
- Keywords
- ischemic stroke, phlegm dampness syndrome, traditional Chinese medicine, proteomic
- Medical subject headings
- Disease, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A(healthy control group) | patients who did not have ischemic stroke and whose TCM constitution was dialectically peaceful; | |
| B | Patients with no ischemic stroke and whose TCM constitution was dialectical with damp phlegm constitution | |
| C | patients with ischemic stroke diagnosed with phlegm dampness syndrome | |
| D | patients with ischemic stroke diagnosed as non-phlegm dampness syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentially expressed proteins of urine and saliva
Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.
Measured: 1 day
Secondary outcomes (3)
NIHSS scoes
NIHSS scoring scale for neurological impairment assessment
Measured: 1 day
modified Rankin Scale (mRS) score
mRS score for the degree of dependence
Measured: 1 day
BI index
BI index for living ability assessment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein; DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Cadre Health Management Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472754
- Sponsor's protocol ID
- 8388
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biological Basis of Phlegm Dampness Syndrome in Patients With Ischemic Stroke：A Saliva and Urine Proteomics Study
- ClinicalTrials.gov ID
- NCT04472754
- Acronym / sponsor ID
- 8388
- Conditions
- Protein; Disease
- Keywords
- ischemic stroke, phlegm dampness syndrome, traditional Chinese medicine, proteomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Guangzhou Cadre Health Management Center
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Jul 2020 (actual)
- 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.
This study aimed to explorie the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.
Detailed description
Stroke is the disease with the highest mortality and disability in China, and the annual incidence of ischemic stroke is the highest. Atherosclerosis is the main cause of ischemic stroke. According to the theory of traditional Chinese medicine, the disease is closely related to the physical constitution of the individual. The main body constitution of the population in Lingnan area is phlegm dampness syndrome;Previous large cross-sectional studies have found that 65.3% of patients with ischemic stroke in Lingnan area have phlegm dampness syndrome. However, there is currently no biological evidence related to phlegm-dampness syndrome and ischemic stroke.In recent years, proteomics research technology has developed vigorously. The research samples have developed from blood obtained from minimally invasive to urine and saliva obtained non-invasively. Studies have found that urine proteins associated with AS include type I, type III collagen, 8-isoprostaglandin F2α, and saliva proteins include IL-1β, IL-6, TNF-α, and PGE2.Therefore, this research is dedicated to exploring the biological basis of phlegm-dampness syndrome in patients with ischemic stroke using proteomics research techniques of urine and saliva.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A(healthy control group) | – | –patients who did not have ischemic stroke and whose TCM constitution was dialectically peaceful; |
| B | – | –Patients with no ischemic stroke and whose TCM constitution was dialectical with damp phlegm constitution |
| C | – | –patients with ischemic stroke diagnosed with phlegm dampness syndrome |
| D | – | –patients with ischemic stroke diagnosed as non-phlegm dampness syndrome |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population are people who diagnosed as ischemic stroke at Guangdong Provincial Hospital of Chinese Medicine The healthy volunteers are definted as people who have no history of cerebrovascular diseases (including cerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.)
Key inclusion criteria (3 listed)
- Clinical diagnosis of ischemic stroke
- Aged 35-80-year-old.
- Agree to participate in clinical research and sign informed consent.
Key exclusion criteria (5 listed)
- Clinical diagnosis of cerebral hemorrhage;
- With severe infection, severe renal dysfunction, and tumor;
- Clinical diagnosis of acute oral inflammation, oral ulcers, or urinary infections;
- Clinical diagnosis of systemic lupus erythematosus and rheumatoid arthritis;
- Pregnant women or lactating mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differentially expressed proteins of urine and saliva
Time frame: 1 day
Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.
3 secondary outcomes
NIHSS scoes
Time frame: 1 day
modified Rankin Scale (mRS) score
Time frame: 1 day
BI index
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Protein; Disease, run by Guangzhou University of Traditional Chinese Medicine.
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 3 inclusion and 5 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 15 Jul 2020. 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?
Differentially expressed proteins of urine and saliva (time frame: 1 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 15 Jul 2020.