SFYDS: Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04806490
• Collaborator: China Academy of Chinese Medical Sciences (Other), Nanjing University of Chinese Medicine (Other), Beijing University of Chinese Medicine (Other)
• Enrollment: 1,200
• Location: 1
• Anticipated Duration (Months): 43.4
• Patients Per Site Per Month: 27.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Yin Deficiency Syndrome	Diagnostic Test: the diagnosis for Yin Deficiency Syndrome

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Establish and Validate Study of Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
• Actual Study Start Date: May 21, 2019
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: the diagnosis for Yin Deficiency Syndrome; The measurement of the standard scale for syndrome differentiation of 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.	Diagnostic Test: the diagnosis for Yin Deficiency Syndrome; The measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome

Outcome Measures

Primary Outcome Measures

1. the diagnostic cut-off value of scale [12 months]

   find out the diagnostic cut-off value of the standard scale for syndrome differentiation of Yin Deficiency Syndrome.

Secondary Outcome Measures

1. Accuracy of the Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome [12 months]

   By comparing the consistency between the scale diagnosis and expert diagnosis, the accuracy of the scale diagnosis of Yin deficiency syndrome was judged.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participates who not meet eligibility criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing		China

Sponsors and Collaborators

• Peking University Third Hospital
• China Academy of Chinese Medical Sciences
• Nanjing University of Chinese Medicine
• Beijing University of Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04806490
• Other Study ID Numbers: 2018YFC1704401
• First Posted: Mar 19, 2021
• Last Update Posted: Mar 19, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: standard scale; syndrome differentiation; Yin Deficiency Syndrome
• Additional relevant MeSH terms: Syndrome; Yin Deficiency

Study Results

No Results Posted as of Mar 19, 2021