Traditional Chinese MedicinePDR SKYDNCT04909489
PDR and SKYD of Dyslipidemia's Characteristics From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway
An observational study of Traditional Chinese Medicine and Dyslipidemias, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Traditional Chinese Medicine, Dyslipidemias, Syndrome
- What is being tested?
- cross-sectional study without intervention
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to 31 Mar 2023
- How long will I take part?
- 2 Years
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this study, 240 patients meet the inclusion criteria, including 100 cases of SKYD group and 100 cases of PDR group. Another 40 cases are NC group.
Who may be able to join
- inclusion criteria of dyslipidemia with SKYD and PDR. (1) subjects with dyslipidemia in accordance with the diagnostic standards and TCM syndrome diagnostic standards, (2) ranged in age from 20 to 80, (3) who signed the informed consent, and (4) without lipid-lowering medications.
- inclusion criteria of NC. (1) healthy subjects, (2) ranged in age from 20 to 80, (3) who signed the informed consent.
Who cannot join
- Exclusion criteria of dyslipidemia with SKYD and PDR. The exclusion criteria were composed of four criteria and a patient was excluded if they fails on any of the criteria. Mentioned criteria were: (1) secondary dyslipidemia (causes of dyslipidemia include but not limited to hypothyroidism, nephrotic syndrome, chronic renal failure, liver diseases, diseases of the hematopoietic system, adrenal-corticosteroid or contraceptive-drug induced dyslipidemia); (2) aphasias, and patients had difficulties to speak or unable to extend tongue for tongue observation; (3) patients with psychosis or unable to answer questions properly; (4) patients with acute infectious diseases or in the acute disease states (such as acute myocardial infarction, acute cerebrovascular disease, etc.), as well as pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Dongcheng, 100700
Chao Ye, doctor, +8615910603713, yechao@bucm.edu.cn
About this study
Official title: Study on the Characteristics of Phlegm-Dampness Retention Syndrome and the Spleen and Kidney Yang Deficiency of Dyslipidemia From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway
Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and "disease syndrome cell model" will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.
Read the detailed description
Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and "disease syndrome cell model" will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.
- Conditions
- Traditional Chinese Medicine, Dyslipidemias, Syndrome
- Being tested
- cross-sectional study without intervention
- Keywords
- metabonomics, syndrome, dislipidemia, serine metabolic pathway, Chinese medicine, PHGDH
- Medical subject headings
- Dyslipidemias, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional study without interventionOther
cross-sectional study without intervention
| Study group | Role | What they receive |
|---|---|---|
| PDR group | Phlegm-Dampness Retention syndrome group Receives: Other: cross-sectional study without intervention | |
| SKYD group | Spleen and Kidney Yang Deficiency syndrome group Receives: Other: cross-sectional study without intervention | |
| NC group | Normal Control group Receives: Other: cross-sectional study without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine Blood Examination
PDR group, SKYD group and NC group's Routine Blood Examination
Measured: 2 years
Blood Biochemistry
PDR group, SKYD group and NC group's Blood Biochemistry
Measured: 2 years
Routine Urine Examination
PDR group, SKYD group and NC group's Routine Urine Examination
Measured: 2 years
the Methylation Level of PHGDH
Methylation sensitive restriction enzyme technique combined with PCR (msre-pcr) will be used to detect the Methylation Level of PHGDH in PDR group, SKYD group and NC group.
Measured: 2 years
the Methylation Level of PHGDH in the cell models of disease-TCM syndrome
Methylation sensitive restriction enzyme technique combined with PCR (msre-pcr) will be used to detect the Methylation Level of PHGDH in the cell models of disease-TCM syndrome.
Measured: 2 years
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter
The distribution of h3k4me3, H3K9Ac and h3k27ac histones in the promoter of PHGDH gene will be detected by chromatin immunoprecipitation assay (chip) in PDR group, SKYD group and NC group.
Measured: 2 years
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter in the cell models of disease-TCM syndrome
The distribution of h3k4me3, H3K9Ac and h3k27ac histones in the promoter of PHGDH gene will be detected by chromatin immunoprecipitation assay (chip) in the cell models of disease-TCM syndrome.
Measured: 2 years
3-phosphoglycerate dehydrogenase (PHGDH) RNA
PHGDH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group.
Measured: 2 years
3-phosphoglycerate dehydrogenase (PHGDH) RNA in the cell models of disease-TCM syndrome
PHGDH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Measured: 2 years
Phosphoserine aminotransferase (PSAT1) RNA
PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Measured: 2 years
Phosphoserine aminotransferase (PSAT1) RNA in the cell models of disease-TCM syndrome
PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Measured: 2 years
Phosphoserine acid phosphatase (PSPH) RNA
PSPH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group.
Measured: 2 years
Phosphoserine acid phosphatase (PSPH) RNA in the cell models of disease-TCM syndrome
PSPH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Measured: 2 years
Serine
Serine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
Measured: 2 years
the differences of metabonomics in the cell models of disease-TCM syndrome
The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in the cell models of disease-TCM syndrome.
Measured: 2 years
the differences of transcriptomics in the cell models of disease-TCM syndrome
The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in the cell models of disease-TCM syndrome.
Measured: 2 years
the differences of metabonomics
The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in PDR group, SKYD group and NC group.
Measured: 2 years
the differences of proteomics in the cell models of disease-TCM syndrome
The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in the cell models of disease-TCM syndrome.
Measured: 2 years
the differences of transcriptomics
The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in PDR group, SKYD group and NC group.
Measured: 2 years
the differences of proteomics
The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in PDR group, SKYD group and NC group.
Measured: 2 years
Malondialdehyde (MDA) in the cell models of disease-TCM syndrome
Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome.
Measured: 2 years
Malondialdehyde (MDA)
Determination of MDA content by thiobarbituric acid method in PDR group, SKYD group and NC group.
Measured: 2 years
Superoxide Dismutase (SOD) in the cell models of disease-TCM syndrome.
Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome.
Measured: 2 years
Superoxide Dismutase (SOD)
Determination of SOD activity by xanthine oxidase method in PDR group, SKYD group and NC group.
Measured: 2 years
Peroxynitrite anion (ONOO-) in the cell models of disease-TCM syndrome
ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome.
Measured: 2 years
Peroxynitrite anion (ONOO-)
ONOO- will be detected by ELISA in PDR group, SKYD group and NC group.
Measured: 2 years
Nicotinamide Adenine Dinucleotide Phosphate (NADPH) the cell models of disease-TCM syndrome
NADPH will be detected by ELISA in the cell models of disease-TCM syndrome.
Measured: 2 years
Nicotinamide Adenine Dinucleotide Phosphate (NADPH)
NADPH will be detected by ELISA in PDR group, SKYD group and NC group.
Measured: 2 years
Glutathione (GSH) in the cell models of disease-TCM syndrome.
GSH will be detected by ELISA in the cell models of disease-TCM syndrome.
Measured: 2 years
Glutathione (GSH)
GSH will be detected by ELISA in PDR group, SKYD group and NC group.
Measured: 2 years
3-phosphoglycerate dehydrogenase（PHGDH） in the cell models of disease-TCM syndrome
PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome.
Measured: 2 years
3-phosphoglycerate dehydrogenase（PHGDH）
PHGDH will be detected by ELISA in PDR group, SKYD group and NC group.
Measured: 2 years
Threonine in the cell models of disease-TCM syndrome
Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Measured: 2 years
Threonine
Threonine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
Measured: 2 years
Glycine in the cell models of disease-TCM syndrome
Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Measured: 2 years
Glycine
Glycine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
Measured: 2 years
The clinical TCM scores of SKYD
The minimum value is 0 and maximum value is 35, and higher scores mean a worse outcome.
Measured: 2 years
The clinical TCM scores of PDR
The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start21 Apr 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Chinese MedicineStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Ye, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909489
- Sponsor's protocol ID
- 2021DZMEC-047-02
- Acronym
- PDR SKYD
- Status last verified
- Aug 2021
- First submitted
- 23 May 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Characteristics of Phlegm-Dampness Retention Syndrome and the Spleen and Kidney Yang Deficiency of Dyslipidemia From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway
- ClinicalTrials.gov ID
- NCT04909489
- Acronym / sponsor ID
- PDR SKYD / 2021DZMEC-047-02
- Conditions
- Traditional Chinese Medicine, Dyslipidemias, Syndrome
- Keywords
- metabonomics, syndrome, dislipidemia, serine metabolic pathway, Chinese medicine, PHGDH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 1 Jun 2021 (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.
Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and "disease syndrome cell model" will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.
Detailed description
Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and "disease syndrome cell model" will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDR group | – | Other: cross-sectional study without interventionPhlegm-Dampness Retention syndrome group |
| SKYD group | – | Other: cross-sectional study without interventionSpleen and Kidney Yang Deficiency syndrome group |
| NC group | – | Other: cross-sectional study without interventionNormal Control group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, 240 patients meet the inclusion criteria, including 100 cases of SKYD group and 100 cases of PDR group. Another 40 cases are NC group.
Key inclusion criteria (2 listed)
- inclusion criteria of dyslipidemia with SKYD and PDR. (1) subjects with dyslipidemia in accordance with the diagnostic standards and TCM syndrome diagnostic standards, (2) ranged in age from 20 to 80, (3) who signed the informed consent, and (4) without lipid-lowering medications.
- inclusion criteria of NC. (1) healthy subjects, (2) ranged in age from 20 to 80, (3) who signed the informed consent.
Key exclusion criteria (1 listed)
- Exclusion criteria of dyslipidemia with SKYD and PDR. The exclusion criteria were composed of four criteria and a patient was excluded if they fails on any of the criteria. Mentioned criteria were: (1) secondary dyslipidemia (causes of dyslipidemia include but not limited to hypothyroidism, nephrotic syndrome, chronic renal failure, liver diseases, diseases of the hematopoietic system, adrenal-corticosteroid or contraceptive-drug induced dyslipidemia); (2) aphasias, and patients had difficulties to speak or unable to extend tongue for tongue observation; (3) patients with psychosis or unable to answer questions properly; (4) patients with acute infectious diseases or in the acute disease states (such as acute myocardial infarction, acute cerebrovascular disease, etc.), as well as pregnant women.
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 |
|---|---|---|
| cross-sectional study without interventioncross-sectional study without intervention | Other | NC group, PDR group, SKYD group |
Primary outcome
Routine Blood Examination
Time frame: 2 years
PDR group, SKYD group and NC group's Routine Blood Examination
Blood Biochemistry
Time frame: 2 years
PDR group, SKYD group and NC group's Blood Biochemistry
Routine Urine Examination
Time frame: 2 years
PDR group, SKYD group and NC group's Routine Urine Examination
the Methylation Level of PHGDH
Time frame: 2 years
Methylation sensitive restriction enzyme technique combined with PCR (msre-pcr) will be used to detect the Methylation Level of PHGDH in PDR group, SKYD group and NC group.
the Methylation Level of PHGDH in the cell models of disease-TCM syndrome
Time frame: 2 years
Methylation sensitive restriction enzyme technique combined with PCR (msre-pcr) will be used to detect the Methylation Level of PHGDH in the cell models of disease-TCM syndrome.
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter
Time frame: 2 years
The distribution of h3k4me3, H3K9Ac and h3k27ac histones in the promoter of PHGDH gene will be detected by chromatin immunoprecipitation assay (chip) in PDR group, SKYD group and NC group.
Distribution of h3k4me3, H3K9Ac and h3k27ac histones in PHGDH gene promoter in the cell models of disease-TCM syndrome
Time frame: 2 years
The distribution of h3k4me3, H3K9Ac and h3k27ac histones in the promoter of PHGDH gene will be detected by chromatin immunoprecipitation assay (chip) in the cell models of disease-TCM syndrome.
3-phosphoglycerate dehydrogenase (PHGDH) RNA
Time frame: 2 years
PHGDH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group.
3-phosphoglycerate dehydrogenase (PHGDH) RNA in the cell models of disease-TCM syndrome
Time frame: 2 years
PHGDH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Phosphoserine aminotransferase (PSAT1) RNA
Time frame: 2 years
PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Phosphoserine aminotransferase (PSAT1) RNA in the cell models of disease-TCM syndrome
Time frame: 2 years
PSAT1 RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Phosphoserine acid phosphatase (PSPH) RNA
Time frame: 2 years
PSPH RNA level will be detected by fluorescence quantitative PCR in PDR group, SKYD group and NC group.
Phosphoserine acid phosphatase (PSPH) RNA in the cell models of disease-TCM syndrome
Time frame: 2 years
PSPH RNA level will be detected by fluorescence quantitative PCR in the cell models of disease-TCM syndrome.
Serine
Time frame: 2 years
Serine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
the differences of metabonomics in the cell models of disease-TCM syndrome
Time frame: 2 years
The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in the cell models of disease-TCM syndrome.
the differences of transcriptomics in the cell models of disease-TCM syndrome
Time frame: 2 years
The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in the cell models of disease-TCM syndrome.
the differences of metabonomics
Time frame: 2 years
The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in PDR group, SKYD group and NC group.
the differences of proteomics in the cell models of disease-TCM syndrome
Time frame: 2 years
The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in the cell models of disease-TCM syndrome.
the differences of transcriptomics
Time frame: 2 years
The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in PDR group, SKYD group and NC group.
the differences of proteomics
Time frame: 2 years
The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in PDR group, SKYD group and NC group.
Malondialdehyde (MDA) in the cell models of disease-TCM syndrome
Time frame: 2 years
Determination of MDA content by thiobarbituric acid method in the cell models of disease-TCM syndrome.
Malondialdehyde (MDA)
Time frame: 2 years
Determination of MDA content by thiobarbituric acid method in PDR group, SKYD group and NC group.
Superoxide Dismutase (SOD) in the cell models of disease-TCM syndrome.
Time frame: 2 years
Determination of SOD activity by xanthine oxidase method in the cell models of disease-TCM syndrome.
Superoxide Dismutase (SOD)
Time frame: 2 years
Determination of SOD activity by xanthine oxidase method in PDR group, SKYD group and NC group.
Peroxynitrite anion (ONOO-) in the cell models of disease-TCM syndrome
Time frame: 2 years
ONOO- will be detected by ELISA in the cell models of disease-TCM syndrome.
Peroxynitrite anion (ONOO-)
Time frame: 2 years
ONOO- will be detected by ELISA in PDR group, SKYD group and NC group.
Nicotinamide Adenine Dinucleotide Phosphate (NADPH) the cell models of disease-TCM syndrome
Time frame: 2 years
NADPH will be detected by ELISA in the cell models of disease-TCM syndrome.
Nicotinamide Adenine Dinucleotide Phosphate (NADPH)
Time frame: 2 years
NADPH will be detected by ELISA in PDR group, SKYD group and NC group.
Glutathione (GSH) in the cell models of disease-TCM syndrome.
Time frame: 2 years
GSH will be detected by ELISA in the cell models of disease-TCM syndrome.
Glutathione (GSH)
Time frame: 2 years
GSH will be detected by ELISA in PDR group, SKYD group and NC group.
3-phosphoglycerate dehydrogenase（PHGDH） in the cell models of disease-TCM syndrome
Time frame: 2 years
PHGDH will be detected by ELISA in the cell models of disease-TCM syndrome.
3-phosphoglycerate dehydrogenase（PHGDH）
Time frame: 2 years
PHGDH will be detected by ELISA in PDR group, SKYD group and NC group.
Threonine in the cell models of disease-TCM syndrome
Time frame: 2 years
Threonine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Threonine
Time frame: 2 years
Threonine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
Glycine in the cell models of disease-TCM syndrome
Time frame: 2 years
Glycine levels will be measured by targeted metabonomics in the cell models of disease-TCM syndrome.
Glycine
Time frame: 2 years
Glycine levels will be measured by targeted metabonomics in PDR group, SKYD group and NC group.
The clinical TCM scores of SKYD
Time frame: 2 years
The minimum value is 0 and maximum value is 35, and higher scores mean a worse outcome.
The clinical TCM scores of PDR
Time frame: 2 years
The minimum value is 0 and maximum value is 44, and higher scores mean a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traditional Chinese Medicine and Dyslipidemias, run by Dongzhimen Hospital, Beijing at 1 site in China.
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 2 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 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Chao Ye, Doctor (+8615910603713, yechao@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Routine Blood Examination (time frame: 2 years). The study lists 38 primary outcomes in all. 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 19 Aug 2021.