Common type of psoriasis (blood stasis syndrome)
Conditions
Interventions
High-does group:Drug 1:Shao Ling tablets, 5 tablets per dose, 3 times daily, by mouth, for a 12-week course. Drug 2:Shao Ling tablets, 3 tablets per dose, 3 times daily, by mouth, for a 12-week cours
Low-dose group:Drug 1:Shao Ling tablets, 5 tablets per dose,3 times daily, orally, for a 12-week course. Drug 2:Shao Ling tablet simulator,3 tablets per dose,3 times daily, orally, for a 12-week cour
Control Group:Drug 1:Shao Ling simulator, 5 tablets per dose, 3 times daily, by mouth, 12-week course. Drug 2:Shao Ling simulator, 3 tablets per dose, 3 times daily, by mouth, 12-week course.
Sponsors
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those who agree to participate in this clinical trial and sign a written informed consent; 2. Aged 18-65 years (including 18 and 65 years of age), with no gender restrictions; 3. Diagnosed with psoriasis vulgaris; 4. Meeting the diagnostic criteria for blood stasis syndrome in traditional Chinese medicine; 5. At baseline, the disease is in the stable phase; 6. At baseline, 3% = body surface area (BSA) < 10%, 3 = Psoriasis Area and Severity Index (PASI) score < 10, and 6 = Dermatology Life Quality Index (DLQI) score < 10.
Exclusion criteria
Exclusion criteria: 1.Known or suspected history of allergy or severe adverse reactions to the investigational drug or its excipients. 2.Patients with predominant drop-like skin lesions or lesions localized to the face,scalp,nails, flexural areas, glans, mucosa, palms, or soles. 3.Patients with pustular psoriasis,erythrodermic psoriasis,psoriatic arthritis,drug-induced or drug-aggravated psoriasis,or acute progression of psoriasis with a tendency toward erythroderma. 4.Patients who have previously received the following psoriasis treatments:1)Topical anti-psoriasis drugs within the past 2 weeks before randomization (e.g.,vitamin D3 analogs,retinoids,corticosteroids,calcineurin inhibitors,anti-human interleukin-8 (IL-8) monoclonal antibodies,and tar formulations,etc.);2)Physical therapy (e.g.,phototherapy [including PUVA and/or NB-UVB],combined phototherapy,or bath therapy) or systemic psoriasis medications within the past 4 weeks before randomization (including but not limited to systemic corticosteroids,leflunomide,cyclophosphamide,methotrexate,cyclosporine,retinoids,traditional Chinese medicine,and their formulations,etc.);3)Biologic therapies within the past 12 weeks before randomization (including tumor necrosis factor-alpha (TNF-a) antagonists [e.g.,etanercept,infliximab,adalimumab],IL-12/23 antagonists [e.g.,ustekinumab],and IL-17A antagonists [e.g.,secukinumab],etc.). 5.Patients with other skin diseases affecting efficacy assessment at screening,or with large tattoos,birthmarks,or scars in the lesion area at screening. 6.Body mass index (BMI)>30 kg/m². 7.Patients with severe hypertension or diabetes mellitus that remains uncontrolled despite treatment (fasting blood glucose=11.1 mmol/L,systolic blood pressure=160 mmHg,or diastolic blood pressure=100 mmHg),or with severe chronic complications of diabetes (e.g.,neuropathy,diabetic foot,or diabetic retinopathy). 8.Patients with severe cardiovascular diseases (e.g.,unstable angina within the past 3 months;heart failure with New York Heart Association (NYHA) classification=III;myocardial infarction,shock,or life-threatening arrhythmias within the past 6 months;or coronary artery bypass grafting or percutaneous coronary intervention within the past 6 months). 9.Patients with severe hepatic or renal diseases,or abnormal liver or renal function:AST or ALT>1.5 times the upper limit of normal (ULN),or serum creatinine (SCr)>1.2 times ULN. 10.Patients with malignant tumors,acute cerebrovascular accidents,active infections,or water,electrolyte,or acid-base imbalances. 11.Patients with severe respiratory,digestive,hematologic,or hematopoietic system diseases that cannot be controlled with standard therapy. 12.Patients with clinically significant abnormalities detected on liver or spleenultrasound. 13.Patients with Hamilton Anxiety Scale scores>14 or Hamilton Depression Scale scores>17. 14.Patients with epilepsy,neurological,or psychiatric disorders who are unable or unwilling to cooperate. 15.Patients with known or suspected history of alcohol abuse,drug abuse,or dependence. 16.Pregnant or breastfeeding women,or women planning pregnancy within the next year. 17.Patients who have participated in other clinical trials within the past3months. 18.Patients deemed unsuitable for participation in this trial by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants achieving psoriasis areaand severity index 50 (PASI50) at 12 weeks after treatment.;Psoriasis areaand severity index 50 (PASI50) refers to a reduction of =50% in Psoriasis Areaand Severity Index scores compared to baseline after treatment. Evaluate the differences in the proportion of subjects achieving PASI50 among the three groups at 12 weeks after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate within 24 weeks of follow-up.;The proportion of subjects achieving psoriasis areaand severity index 50 (PASI50) at 2, 4, 8 weeks after treatment and 4, 8, 12, 16, 20, 24 weeks after the end of treatment.;The proportion of subjects achieving psoriasis areaand severity index 75 (PASI75) at weeks 2, 4, 8, and 12 after treatment, and weeks 4, 8, 12, 16, 20, and 24 after treatment.;Improvement rate in psoriasis areaand severity index (PASI) scores at 2, 4, 8, 12 weeks after treatment and at 4, 8, 12, 16, 20, 24 weeks after the end of treatment.;The change from baseline in the body surface area (BSA) of subjects at 2, 4, 8, 12 weeks post-treatment and 4, 8, 12, 16, 20, 24 weeks post-medication.;After treatment at 2, 4, 8, and 12 weeks, and after the end of medication at 4, 8, 12, 16, 20, and 24 weeks, the changes in patient-reported itching scores (VAS) from baseline.;At weeks 4, 8, and 12 after treatment and weeks 12 and 24 after medication discontinuation, the change in Dermatology Life Quality Index (DLQI) scores compared to baseline.;The percentage of subjects who used emergency medications and the dosage of emergency medications used during the trial.;Efficacy of TCM syndromes (including improvement rate of scores in the main syndrome scale and disappearance rate of single symptoms); | — |
Countries
China
Contacts
Public ContactYang Zhibo
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Outcome results
None listed