Comprehensive Intervention of Diabetes and Psoriasis Comorbidity Prevention and Control

Shanghai Yueyang Integrated Medicine Hospital

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Psoriasis; Diabetes

Treatments: Other: TCM comprehensive treatment; Drug: Western medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT06402760

GWVI-11.1-24

Details and patient eligibility

About

We will recruit 300 patients with psoriasis from Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, who will not be currently diagnosed with diabetes but will have been identified as high-risk individuals based on the developed risk assessment model. Based on doctor's treatment opinions and patient preferences, participants will be divided into two groups in a 1:1 ratio: a Western medicine group and a TCM comprehensive treatment group.

Patients in the Western medicine group will receive treatment according to guidelines. Patients in the TCM comprehensive treatment group will be treated according to the guidelines and will additionally receive Taodan granules (to be taken daily during the treatment period after brewing the granules with lukewarm water in the morning and evening) and fish oil (1g, taken orally twice daily).

Patients in the TCM comprehensive treatment group will be required to complete at least 150 minutes of moderate-intensity aerobic exercise per week under the supervision of a physician. The patients will be treated for 16 weeks and followed up for 24 weeks to see if the treatment prevents the development of diabetes or insulin resistance.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the Western medicine diagnostic criteria for vulgaris psoriasis and the Traditional Chinese Medicine diagnostic criteria for blood stasis syndrome in psoriasis.
2. Newly diagnosed or previously diagnosed with psoriasis; if previously diagnosed, prior treatment methods are not restricted.
3. Identified as high risk for comorbid diabetes based on a risk model calculation.
4. Age between 18 and 80 years old, any gender.
5. Willing to participate in this study and provide informed consent.

Exclusion criteria

1. Patients already diagnosed with diabetes.

2. Presence of other active skin diseases that may affect the assessment of the condition.

3. In severe, difficult-to-control acute or chronic infection locally or systemically.

4. Severe systemic diseases; or patients with clinical laboratory indicators falling into any of the following conditions:

   ① Hematology: Hemoglobin (HGB) < 90g/L; Platelet count (PLT) < 10010^9/L; White blood cell count (WBC) < 310^9/L; Absolute neutrophil count (NEUT) < 1.5*10^9/L;

   ② Liver function: Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal;

   ③ Renal function: Serum creatinine greater than 1.5 times the upper limit of normal;

   ④ Other abnormal laboratory test results judged by the investigator to potentially affect the patient's completion of the trial or interfere with the trial results.

5. History of malignant tumors and primary or secondary immunodeficiency or hypersensitivity.

6. Underwent major surgery within 8 weeks or will require such surgery during the study period.

7. Pregnant or lactating women.

8. History of alcoholism, drug abuse, or substance abuse.

9. History of severe mental illness or family history thereof.

10. Family history of tumors.

11. Other reasons deemed inappropriate for participation by the investigator.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Western medicine group

Active Comparator group

Description:

Treatment will be stratified according to the severity of psoriasis in patients, with therapeutic methods limited to the traditional treatment approaches outlined in the Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Simplified Version). The treatment duration will be 16 weeks, followed by a 24-week follow-up period during which patients will not be restricted in their treatment modalities.

Treatment:

Drug: Western medicine

TCM comprehensive treatment group

Experimental group

Description:

In addition to the Western medicine treatment prescribed in the guidelines, patients are required to take fish oil orally and Taodan Granules, and engage in moderate to high-intensity aerobic exercise weekly.

Treatment:

Other: TCM comprehensive treatment