Psoriasis (PsO)NCT07351448
Research on the Extraction of Tongue and Facial Diagnosis Features of Psoriasis Vulgaris in Traditional Chinese Medicine and Its Correlation With Laboratory Indicators
An observational study of Psoriasis (PsO) and Traditional Chinese Medicine (TCM), run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis (PsO), Traditional Chinese Medicine (TCM), Diagnosis
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Sep 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Inclusion criteria for the non-psoriasis subjects: (1) Those who do not meet the Western medical diagnostic criteria for psoriasis; （2) No gender restrictions; 18 years old ≤ age ≤ 65 years old; (3) Understand and agree to participate in this study and sign the informed consent form; Inclusion criteria for the psoriasis blood stasis syndrome group: (1) Those who meet the Western medical diagnostic criteria for psoriasis and whose TCM syndrome classification belongs to blood stasis syndrome; (2) No gender restrictions; 18 years old ≤ age ≤ 65 years old; (3) Understand and agree to participate in this study and sign the informed consent form.
- Inclusion criteria for the psoriasis non-blood stasis syndrome group: (1) Those who meet the Western medical diagnostic criteria for psoriasis and whose TCM syndrome classification belongs to blood heat syndrome/blood dryness syndrome; (2) No gender restrictions; 18 years old ≤ age ≤ 65 years old; (3) Understand and agree to participate in this study and sign the informed consent form.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, 200433
Xiaofei Yi, 13052351886, xfyiyi@126.com
About this study
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.
- Being tested
- No intervention
- Medical subject headings
- Psoriasis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study, no intervention implemented.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention | |
| Psoriasis blood stasis syndrome group | Patients with psoriasis diagnosed as having blood stasis syndrome Receives: Other: No intervention | |
| Psoriasis non-blood stasis syndrome group | Patients with psoriasis diagnosed as not having blood stasis syndrome Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Images
Measured: 1 day (Collect the images of the patient's tongue and face using a tongue surface scanner)
Secondary outcomes (3)
Serum metabolomics data
Measured: 1 day (Collect the serum and send it to the testing company for metabolomics testing)
Psoriasis Area and Severity Index (PASI)
Measured: The researcher conducted a Psoriasis Area and Severity Index (PASI) assessment on the psoria on the 1 day of sample collection
Inflammatory factor
Measured: 1 day （Collect serum and test the levels of IFN-γ, TNF-α and IL-17）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies 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
- 450 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351448
- Sponsor's protocol ID
- 2025-206
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Extraction of Tongue and Facial Diagnosis Features of Psoriasis Vulgaris in Traditional Chinese Medicine and Its Correlation With Laboratory Indicators
- ClinicalTrials.gov ID
- NCT07351448
- Acronym / sponsor ID
- 2025-206
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-psoriasis subjects | – | Other: No interventionWho 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. |
| Psoriasis blood stasis syndrome group | – | Other: No interventionPatients with psoriasis diagnosed as having blood stasis syndrome |
| Psoriasis non-blood stasis syndrome group | – | Other: No interventionPatients with psoriasis diagnosed as not having blood stasis syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Inclusion criteria for the non-psoriasis subjects: (1) Those who do not meet the Western medical diagnostic criteria for psoriasis; （2) No gender restrictions; 18 years old ≤ age ≤ 65 years old; (3) Understand and agree to participate in this study and sign the informed consent form; Inclusion criteria for the psoriasis blood stasis syndrome group: (1) Those who meet the Western medical diagnostic criteria for psoriasis and whose TCM syndrome classification belongs to blood stasis syndrome; (2) No gender restrictions; 18 years old ≤ age ≤ 65 years old; (3) Understand and agree to participate in this study and sign the informed consent form.
- Inclusion criteria for the psoriasis non-blood stasis syndrome group: (1) Those who meet the Western medical diagnostic criteria for psoriasis and whose TCM syndrome classification belongs to blood heat syndrome/blood dryness syndrome; (2) No gender restrictions; 18 years old ≤ age ≤ 65 years old; (3) Understand and agree to participate in this study and sign the informed consent form.
Key exclusion criteria (1 listed)
- (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.
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 |
|---|---|---|
| No interventionThis is an observational study, no intervention implemented. | Other | Non-psoriasis subjects, Psoriasis blood stasis syndrome group, Psoriasis non-blood stasis syndrome group |
Primary outcome
Images
Time frame: 1 day (Collect the images of the patient's tongue and face using a tongue surface scanner)
3 secondary outcomes
Serum metabolomics data
Time frame: 1 day (Collect the serum and send it to the testing company for metabolomics testing)
Psoriasis Area and Severity Index (PASI)
Time frame: The researcher conducted a Psoriasis Area and Severity Index (PASI) assessment on the psoria on the 1 day of sample collection
Inflammatory factor
Time frame: 1 day （Collect serum and test the levels of IFN-γ, TNF-α and IL-17）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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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.
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 Psoriasis (PsO) and Traditional Chinese Medicine (TCM), run by Shanghai Yueyang Integrated Medicine 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: opening soon, as of the sponsor's last update on 20 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Li, Doctor (13661956326, 13661956326@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Images (time frame: 1 day (Collect the images of the patient's tongue and face using a tongue surface scanner)). 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 20 Jan 2026.