Clinical trial NCT03952676: Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
Official title: Clinical Evaluation of Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Blood stasis syndrome
Randomized controlled trial
Moving cupping
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Shaanxi Traditional Chinese Medicine Hospital
name: Heilongjiang University of Chinese Medicine
name: Shijiazhuang traditional Chinese medicine hospital
name: The Affiliated Hospital of JiangXi University of TCM
name: Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
First posted: 2019-05-16
Enrollment: 122
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: The purpose of this study was to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.

Detailed description: Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost.

Complementary and alternative medicine (CAM) therapies have become an increasingly visible part of dermatology. Cupping is becoming an important therapy in complementary and alternative medicine. Although, moving cupping therapy has been widely used in the treatment of plaque psoriasis and has been recognized by a large number of peers and patients, but still lacks high-quality evidence-based medical evidence. Therefore, the project team intends to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.

Eligibility criteria: Inclusion Criteria:

1. Diagnostic criteria for plaque psoriasis;
2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included);
3. Aged between 18 and 65 years.
4. Consent to participate in the research study and sign the informed consent form

Exclusion Criteria:

1. Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis;
2. Plaque psoriasis patients with BSA\>10%;
3. Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
4. Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit e.g.: drugs for other studies, immuno-suppressive drugs, biologics;
5. Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing;
6. Active infectious disease which was hard to control;
7. History of severe systemic disease. Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times; Any of the main routine blood indexes (WBC, RBC, HB, PLT) is lower than the limit of normal; or other laboratory abnormalities and patients were judged not to be suitable for this study;
8. Family history of cancer-prone patients;
9. Patients with immunocompromised and can cause skin allergies and infection when moving cupping;
10. Pregnant or lactating women;
11. Patients with a history of alcohol abuse and drug abuse;
12. Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.

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: CM symptom score
timeFrame: Up to 28 days after treatment
Other outcomes:
Locations:
city: Harbin
country: China
facility: First Affiliated Hospital, Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Nanchang
country: China
facility: The Affiliated Hospital of Jiangxi University of TCM
state: Jiangxi
city: Xi'an
country: China
facility: Shaanxi Provincial Hospital of traditional Chinese Medicine
state: Shaanxi
city: Shijiazhuang
country: China
facility: Shijiazhuang traditional Chinese medicine hospital
state: Shijiazhuang
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
state: Xinjiang
Study officials:
affiliation: Shanghai Yueyang Integrated Medicine Hospital
name: Jia Zhou
role: STUDY_CHAIR
References:
citation: Xing M, Yan X, Yang S, Li L, Gong L, Liu H, Xu R, Chen J, Ying L, Zhao Y, An Y, Liu Y, Huang G, Guo F, Yin Q, Wang R, Li B, Li X. Effects of moving cupping therapy for plaque psoriasis: study protocol for a randomized multicenter clinical trial. Trials. 2020 Feb 26;21(1):229. doi: 10.1186/s13063-020-4155-0.