Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03952676
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Yueyang Integrated Medicine Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jia Zhou
Principal Investigator Affiliation Shanghai Yueyang Integrated Medicine Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Moving cupping intervention

Participants will received moving cupping therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.

Placebo Comparator: Moving cupping placebo control

Participants will received moving cupping placebo therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.

Interventions

Device: - Moving cupping

We use a black opaque eye mask to shield the patient's eyes and choose different sizes of cup according to the location of the treatment (There are three sizes of cups) (1) First apply Vaseline to the skin lesions area; (2) Then hold the 95% ethanol cotton ball with tweezers, and hold the cup with the facing down, after the cotton ball is ignited, immediately sway down in the cup and then exit, and quickly buckle the cup to the skin lesions area. (3) After using the cup to absorb the skin lesions area, hold the cup body in one hand and push and pull the cup along the certain route with a little strength, so that the skin purple color of the treatment area is suitable. (4) Apply even force when pushing the cup to prevent the cup from falling off due to air leakage. (5) Acting on the skin lesions area 30 times, change cup 5 times per push and pull, the interval is not more than 10 seconds.

Device: - Moving cupping placebo

Using of special perforated cups, the manipulation method is the same as the intervention group.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Harbin, Heilongjiang, China

Status

Address

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang,

Nanchang, Jiangxi, China

Status

Address

The Affiliated Hospital of Jiangxi University of TCM

Nanchang, Jiangxi,

Site Contact

Liping Gong

18930568129@163.com

0086-021-55981301

Xi'an, Shaanxi, China

Status

Address

Shaanxi Provincial Hospital of traditional Chinese Medicine

Xi'an, Shaanxi,

Site Contact

Xiaoning Yan

18930568129@163.com

0086-021-55981301

Shijiazhuang, Shijiazhuang, China

Status

Address

Shijiazhuang traditional Chinese medicine hospital

Shijiazhuang, Shijiazhuang,

Site Contact

Linge Li

18930568129@163.com

0086-021-55981301

Ürümqi, Xinjiang, China

Status

Address

Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Ürümqi, Xinjiang,

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