Clinical trial NCT03953885: Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome
Official title: Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Blood stasis syndrome
Randomized controlled trial
Fire Needle Therapy
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Shaanxi Provincial Hospital of Traditional Chinese Medicine
name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
name: Shijiazhuang Hospital of Traditional Chinese Medicine
name: Heilongjiang University of Chinese Medicine
First posted: 2019-05-17
Enrollment: 92
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: This study was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy.

Detailed description: Psoriasis is a chronic inflammatory skin disease characterized by the complex interaction between the immune system, related susceptibility loci, autoantigens and various environmental factors. In China, the prevalence is about 0.47%. Current treatment strategies for psoriasis mainly focus on developing new drugs that disrupt IL-23 or IL-17 cytokine, but this targeted therapy is not effective for all patients. A growing body of evidence indicates that psoriasis-related damage is not limited to the skin, but is closely related to coronary heart disease, stroke, metabolic syndrome, and chronic kidney disease. These comorbidities have, to a certain extent, increased mortality in patients with psoriasis. Traditional Chinese medicine (TCM) has always been used to treat patients with psoriasis in China. Blood stasis syndrome is one of the basic syndromes of psoriasis. which accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for a long time and is similar to many metabolic related diseases. Fire needle therapy is one of the traditional Chinese specialty treatments, which has effects of warming yang to expel cold, warming and activating meridian, dispersing stasis and relieving pain. Studies have shown that fire needle therapy of plaque psoriasis in stationary phase is effective, with fewer side effects, and can reduce the recurrence rate. This multicenter, randomized, single-blind, placebo-controlled trial will objectively and standardly evaluate the clinical effectiveness, safety and control of recurrence of fire needle therapy to obtain objective evidence of international standards and form clinical norms suitable for popularization and application.

Eligibility criteria: Inclusion Criteria:

1. Comply with the diagnostic criteria of Western medicine for plaque 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 (PASI)
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 28 days after treatment
measure: Patient-reported quality of life (PRQoL)
timeFrame: Up to 28 days after treatment
measure: Visual Analogue Score (VAS)
timeFrame: Up to 56 days after treatment
measure: TCM syndrome score
timeFrame: Up to 56 days after treatment
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Shijiazhuang Hospital of Traditional Chinese Medicine
state: Hebei
city: Ha'erbin
country: China
facility: First Affiliated Hospital of Heilongjiang Chinese Medicine University
state: Heilongjiang
city: Nanchang
country: China
facility: Affiliated hospital of jiangxi university of traditional Chinese medicine
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
state: Shanghai
city: Xi'an
country: China
facility: Shanxi Provincial Hospital of Traditional Chinese Medicine
state: Shanxi
Study officials:
affiliation: Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
name: Jia Zhou
role: STUDY_CHAIR
References:
citation: Liu L, Lu Y, Yan XN, Yang SQ, Gong LP, Li LE, Zhao YD, Yin QF, Wang RP, An YP, Huang G, Zhang JF, Sun XY, Li X, Li B. Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial. Trials. 2020 Aug 25;21(1):739. doi: 10.1186/s13063-020-04691-7.