Yin Deficiency SyndromeSFYDSNCT04806490
Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
An observational study of Yin Deficiency Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
An version of the standard scale for syndrome differentiation of Yin Deficiency Syndrome is not available yet for Chinese medicine. The aim of this study is to develop and validate the standard scale for syndrome differentiation of Yin Deficiency Syndrome. The study is divided into two steps. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Yin Deficiency Syndrome
- What is being tested?
- the diagnosis for Yin Deficiency Syndrome
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2019to 31 Dec 2022
- How long will I take part?
- 12 Months
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the subjects were enrolled continuously in the TCM outpatient department. If the informed consent of the researcher is obtained, the scale measurement of the study subjects can be carried out.
Who may be able to join
- Subject will be recruited from the current outpatients' clinic activity of the affiliated hospitals of Beijing University of Chinese Medicine and Nanjing University of Chinese Medicine. Subjects must be able to read and write in Chinese. After obtained informed consent we will ask them to participate to this study.
- All the subjects need to fill in the scale of Yin Deficiency syndrome and be diagnosed by a specialist in traditional Chinese medicine (TCM) to determine whether they have Yin deficiency syndrome. The judgment of TCM experts is the gold standard.
Who cannot join
- Participates who not meet eligibility criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Yuan Li Tao, Ph.D, tendytly@163.com
About this study
Official title: Establish and Validate Study of Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
An version of the standard scale for syndrome differentiation of Yin Deficiency Syndrome is not available yet for Chinese medicine.
The aim of this study is to develop and validate the standard scale for syndrome differentiation of Yin Deficiency Syndrome. The study is divided into two steps. The first step is to develop the standard scale for syndrome differentiation of Yin Deficiency Syndrome through expert consultation (Delphi method). The second step is to apply the scale in the participants and find out the diagnostic cut-off value of the scale by comparing it with the gold standard.
- Conditions
- Yin Deficiency Syndrome
- Being tested
- the diagnosis for Yin Deficiency Syndrome
- Keywords
- standard scale, syndrome differentiation, Yin Deficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the diagnosis for Yin Deficiency SyndromeDiagnostic test
The measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome
| Study group | Role | What they receive |
|---|---|---|
| Chinese participants with Yin Deficiency Syndrome | The participants with Yin Deficiency syndrome were included in this study. Chinese Medicine Experts evaluated the main symptoms of Yin Deficiency syndrome, diagnosed those participants.
And the participants were measured by the standard scale for syndrome differentiation of Yin Deficiency syndrome. The participants were followed up for 12 months to observe whether there were any manifestations of Yin Deficiency syndrome during the observation period. Receives: Diagnostic Test: the diagnosis for Yin Deficiency Syndrome | |
| Chinese participants without Yin Deficiency Syndrome | The participants without Yin Deficiency syndrome were included in this study. Chinese Medicine Experts evaluated the main symptoms of Yin Deficiency syndrome, diagnosed those participants.
And the participants were measured by the standard scale for syndrome differentiation of Yin Deficiency syndrome. The participants were followed up for 12 months to observe whether there were any manifestations of Yin Deficiency syndrome during the observation period. Receives: Diagnostic Test: the diagnosis for Yin Deficiency Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic cut-off value of scale
find out the diagnostic cut-off value of the standard scale for syndrome differentiation of Yin Deficiency Syndrome.
Measured: 12 months
Secondary outcomes (1)
Accuracy of the Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
By comparing the consistency between the scale diagnosis and expert diagnosis, the accuracy of the scale diagnosis of Yin deficiency syndrome was judged.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start21 May 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yin Deficiency SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Academy of Chinese Medical Sciences, Affiliated Hospital of Nanjing University of Chinese Medicine, Beijing University of Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806490
- Sponsor's protocol ID
- 2018YFC1704401
- Acronym
- SFYDS
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of this study and the publication of relevant research papers, all the research object data in this study will be made public to anyone, but only after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish and Validate Study of Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
- ClinicalTrials.gov ID
- NCT04806490
- Acronym / sponsor ID
- SFYDS / 2018YFC1704401
- Conditions
- Yin Deficiency Syndrome
- Keywords
- standard scale, syndrome differentiation, Yin Deficiency Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- China Academy of Chinese Medical Sciences, Affiliated Hospital of Nanjing University of Chinese Medicine, Beijing University of Chinese Medicine
- Study start
- 21 May 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Mar 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.
An version of the standard scale for syndrome differentiation of Yin Deficiency Syndrome is not available yet for Chinese medicine.
The aim of this study is to develop and validate the standard scale for syndrome differentiation of Yin Deficiency Syndrome. The study is divided into two steps. The first step is to develop the standard scale for syndrome differentiation of Yin Deficiency Syndrome through expert consultation (Delphi method). The second step is to apply the scale in the participants and find out the diagnostic cut-off value of the scale by comparing it with the gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese participants with Yin Deficiency Syndrome | – | Diagnostic Test: the diagnosis for Yin Deficiency SyndromeThe participants with Yin Deficiency syndrome were included in this study. Chinese Medicine Experts evaluated the main symptoms of Yin Deficiency syndrome, diagnosed those participants. And the participants were measured by the standard scale for syndrome differentiation of Yin Deficiency syndrome. The participants were followed up for 12 months to observe whether there were any manifestations of Yin Deficiency syndrome during the observation period. |
| Chinese participants without Yin Deficiency Syndrome | – | Diagnostic Test: the diagnosis for Yin Deficiency SyndromeThe participants without Yin Deficiency syndrome were included in this study. Chinese Medicine Experts evaluated the main symptoms of Yin Deficiency syndrome, diagnosed those participants. And the participants were measured by the standard scale for syndrome differentiation of Yin Deficiency syndrome. The participants were followed up for 12 months to observe whether there were any manifestations of Yin Deficiency syndrome during the observation period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the subjects were enrolled continuously in the TCM outpatient department. If the informed consent of the researcher is obtained, the scale measurement of the study subjects can be carried out.
Key inclusion criteria (2 listed)
- Subject will be recruited from the current outpatients' clinic activity of the affiliated hospitals of Beijing University of Chinese Medicine and Nanjing University of Chinese Medicine. Subjects must be able to read and write in Chinese. After obtained informed consent we will ask them to participate to this study.
- All the subjects need to fill in the scale of Yin Deficiency syndrome and be diagnosed by a specialist in traditional Chinese medicine (TCM) to determine whether they have Yin deficiency syndrome. The judgment of TCM experts is the gold standard.
Key exclusion criteria (1 listed)
- Participates who not meet eligibility criteria
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 |
|---|---|---|
| the diagnosis for Yin Deficiency SyndromeThe measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome | Diagnostic test | Chinese participants with Yin Deficiency Syndrome, Chinese participants without Yin Deficiency Syndrome |
Primary outcome
the diagnostic cut-off value of scale
Time frame: 12 months
find out the diagnostic cut-off value of the standard scale for syndrome differentiation of Yin Deficiency Syndrome.
1 secondary outcome
Accuracy of the Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: Yes. After the completion of this study and the publication of relevant research papers, all the research object data in this study will be made public to anyone, but only after de-identification.
Related trials for Yin Deficiency Syndrome
Not yet recruiting
Shiwei Anshen Granules for Chronic Insomnia
Chronic Insomnia
Not yet recruitingObservational study
Real-World Effectiveness and Costs of Yiqi Fumai Lyophilized Injection in Coronary Heart Disease-Related Chronic Heart Failure
Chronic Heart Failure, Coronary Heart Disease (CHD)
Not yet recruiting
Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease
Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)
Active, not recruiting
Huangqi Gegen Decoction for Endothelial Function in Type 2 Diabetes at Very High ASCVD Risk
Type 2 Diabetes Mellitus, Endothelial Dysfunction
RecruitingObservational study
Prospective Cohort Study on Fuzheng Yangxin Prescription For Rapid Rehabilitation of Patients With Qi-Yin Deficiency Syndrome After Coronary Artery Bypass Grafting
Coronary Artery Bypass
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 Yin Deficiency Syndrome, run by Peking University Third Hospital 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 Mar 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 Liyuan Tao, PhD (+8610-82265571, tendytly@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic cut-off value of scale (time frame: 12 months). 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 Mar 2021.