Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Jueyin granules
- Conditions
- Psoriasis Vulgaris
- Sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Enrollment
- 196
- Locations
- 4
- Primary Endpoint
- Psoriasis area and severity index
- Last Updated
- 6 years ago
Overview
Brief Summary
We designed this study as a multicenter, randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of psoriasis with blood stasis syndrome.
Detailed Description
Psoriasis is a chronic, relapsing, inflammatory, multisystem disease characterized by infiltration of inflammatory cells, hyperplasia of epidermal keratinocytes, and abnormal differentiation. Latest data estimate that the prevalence of psoriasis in adults has increased to 11.43%, which shows that the control and treatment of psoriasis is still insufficient. Recent studies showed that traditional Chinese medicine (TCM) is one of the effective methods for the treatment of psoriasis. More and more evidences support the recognition of psoriasis not only affects the skin, but also suffers a chronic multisystem inflammation. Chinese medicine believes that the blood heat is the root of the onset of psoriasis, so the treatment of psoriasis should focus on the method of clearing heat and cooling blood. Therefore, the method of promoting clearing heat and cooling blood. has always been the focus of TCM treatment and prevention of psoriasis. This multicenter, randomized, double-blind, placebo-controlled trial will provide high-quality clinical evidences for evaluating the efficacy, safety and recurrence rate of Jueyin granule, a representative prescription for the treatment of psoriasis with blood heat syndrome, in the treatment of psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
- •Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
- •Age between 18 and 65 years old;
- •Those who voluntarily participate in the study and sign informed consent.
Exclusion Criteria
- •Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
- •Other active skin diseases may affect the condition assessment;
- •Received research drugs, biological agents and immunosuppressive agents within 1 month;
- •2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
- •During severe, uncontrollable local or systemic acute or chronic infections;
- •Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by \>1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;
- •A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
- •Such surgery will be required during major surgery or study during 8 weeks;
- •Pregnant or lactating women;
- •A person with a history of alcohol abuse, drug abuse or drug abuse;
Arms & Interventions
Oral Chinese medicine
Participants in experimental group will receive Jueyin granule two times daily after meals three times per week for 8 weeks.
Intervention: Jueyin granules
Oral Chinese medicine placebo
Participants in placebo group will receive Jueyin granule placebo two times daily after meals three times per week for 8 weeks.
Intervention: Jueyin Granules Placebo
Outcomes
Primary Outcomes
Psoriasis area and severity index
Time Frame: Up to 56 days after treatment.
Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \<10%, 2 - 10-\<30%, 3 - 30-\<50%, 4 - 50-\<70%, 5 - 70-\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.
Secondary Outcomes
- Visual Analogue Score (VAS)(Up to 56 days after treatment.)
- TCM symptom score(Up to 56 days after treatment.)
- Body surface area (BSA)(Up to 56 days after treatment.)
- Dermatology Life quality index(DLQI)(Up to 56 days after treatment.)
- Patient-reported quality of life (PRQoL)(Up to 56 days after treatment.)
- Physician Global Assessment (PGA)(Up to 56 days after treatment.)