Clinical trial NCT03961230: Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome
Official title: Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis Vulgaris
Jueyin granules
Blood heat syndrome
Randomized controlled trial
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital of Traditional Chinese Medicine
name: First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Gansu University of Chinese Medicine
name: Guangxi Zhuang Autonomous Region Dermatology Hospital
First posted: 2019-05-23
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
2. 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);
3. Age between 18 and 65 years old;
4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
2. Other active skin diseases may affect the condition assessment;
3. Received research drugs, biological agents and immunosuppressive agents within 1 month;
4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
5. During severe, uncontrollable local or systemic acute or chronic infections;
6. 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;
7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
8. Such surgery will be required during major surgery or study during 8 weeks;
9. Pregnant or lactating women;
10. A person with a history of alcohol abuse, drug abuse or drug abuse;
11. Have a history of serious mental illness or family history;
12. Other reasons researchers believe that it is inappropriate to participate in this research.

Primary outcomes:
measure: Psoriasis area and severity index
timeFrame: Up to 56 days after treatment.
Secondary outcomes:
measure: Body surface area (BSA)
timeFrame: Up to 56 days after treatment.
measure: Physician Global Assessment (PGA)
timeFrame: Up to 56 days after treatment.
measure: Dermatology Life quality index(DLQI)
timeFrame: Up to 56 days after treatment.
measure: Patient-reported quality of life (PRQoL)
timeFrame: Up to 56 days after treatment.
measure: Visual Analogue Score (VAS)
timeFrame: Up to 56 days after treatment.
measure: TCM symptom score
timeFrame: Up to 56 days after treatment.
Other outcomes:
Locations:
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
state: Beijing
city: Nanchang
country: China
facility: Affiliated Hospital of Gansu University of Chinese Medicine
state: Gansu
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region Dermatology Hospital
state: Guizhou
Study officials:
affiliation: Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
name: Jia Zhou
role: STUDY_CHAIR
References:
citation: Li S, Zhang C, Zhang HY, Zhou M, Wang SN, Xu R, Zhou DM, Ji YR, Lv JJ, Yin QF, Wang RP, Li W, Liu YP, Wang JF, Li B, Li X. Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2020 Apr 9;2020:8942301. doi: 10.1155/2020/8942301. eCollection 2020.