NCT07351448

Brief Summary

Psoriasis Vulgaris is a chronic, inflammatory, and immune-activated skin disease. It is the most common type of psoriasis, accounting for approximately 85-90% of all psoriasis patients. Its clinical features include erythema, papules, covered with varying scales, a long course of disease, and recurrent attacks. According to traditional Chinese medicine, psoriasis is mainly characterized by blood heat syndrome, blood stasis syndrome and blood dryness syndrome, accounting for more than 90% of all syndrome types. The TCM syndrome differentiation and treatment of psoriasis also attach great importance to the transformation and evolution of TCM syndrome types. For instance, the three syndrome types of blood heat syndrome, blood stasis syndrome and blood dryness syndrome are not static and can transform into each other. For example, blood heat syndrome can develop into blood dryness syndrome as the disease progresses, blood dryness syndrome can transform into blood stasis syndrome, and blood stasis syndrome can also transform into blood heat syndrome or blood dryness syndrome. Observation is an important diagnostic method in traditional Chinese medicine. The images of tongue and face diagnosis contain a lot of important clinical information. They can objectively reflect the prosperity and decline of qi and blood in the human body, the nature of diseases, the depth of the lesion location, the prognosis of the disease, and can also reflect the physiological and pathological changes of the body. In recent years, significant progress has been made in the research of digital and intelligent technologies for tongue and facial diagnosis. Introducing objective indicators such as tongue diagnosis, facial diagnosis and pulse diagnosis into the evaluation research of diseases has become a hot topic. This project, by analyzing the clinical tongue and facial image data of patients with psoriasis vulgaris and combining it with clinical laboratory indicators, fuses and analyzes the characteristic parameters of patients' tongue and facial diagnosis with blood biochemical indicators, metabolomics and other data. This is helpful to reveal the disease occurrence pattern of patients with blood stasis type psoriasis and construct a diagnostic model for blood stasis syndrome of psoriasis. At the same time, it provides a powerful decision support tool for clinical practice and also helps deepen our understanding of the complex process of the occurrence of blood stasis type psoriasis, thereby providing a solid scientific basis for formulating precise diagnostic and treatment strategies.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Jan 2026Sep 2027

First Submitted

Initial submission to the registry

January 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

Psoriasis (PsO)Traditional Chinese Medicine (TCM)Diagnosis

Outcome Measures

Primary Outcomes (1)

  • Images

    1 day (Collect the images of the patient's tongue and face using a tongue surface scanner)

Secondary Outcomes (3)

  • Serum metabolomics data

    1 day (Collect the serum and send it to the testing company for metabolomics testing)

  • Psoriasis Area and Severity Index (PASI)

    The researcher conducted a Psoriasis Area and Severity Index (PASI) assessment on the psoria on the 1 day of sample collection

  • Inflammatory factor

    1 day （Collect serum and test the levels of IFN-γ, TNF-α and IL-17）

Study Arms (3)

Non-psoriasis subjects

Who visit for non-psoriasis skin conditions such as eczema or acne, and have been professionallyand confirmed by doctors not to have psoriasis, will be chosen as the Non-psoriasis subjects.

Other: No intervention

Psoriasis blood stasis syndrome group

Patients with psoriasis diagnosed as having blood stasis syndrome

Other: No intervention

Psoriasis non-blood stasis syndrome group

Patients with psoriasis diagnosed as not having blood stasis syndrome

Other: No intervention

Interventions

No interventionOTHER

This is an observational study, no intervention implemented.

Non-psoriasis subjectsPsoriasis blood stasis syndrome groupPsoriasis non-blood stasis syndrome group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study intends to select 150 patients with blood stasis syndrome of psoriasis who visited the Department of Dermatology of Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine, as well as 150 patients with non-blood stasis syndrome of psoriasis. Additionally, 150 people who visited the hospital due to non-papular psoriasis skin diseases such as eczema or acne, and who were confirmed by professional doctors to have no psoriasis, will be selected as the non-psoriasis subjects.

You may not qualify if:

  • (1) Due to various reasons, the collected tongue and facial images may be unclear or cannot be successfully monitored and analyzed; (2) For those subjects whose facial makeup or tongue coating is applied, the information obtained from tongue and facial diagnosis may be inaccurate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The collected sample is venous blood.The volume collected for each patient is 8 mL. After centrifugation, the serum is extracted.

MeSH Terms

Conditions

PsoriasisDisease

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xin Li, Doctor

CONTACT

1366195632613661956326@163.com

Munsoon Hong, Doctor

CONTACT

15502131320hms2785@naver.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 20, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

CN(1)