Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial

NCT ID: NCT03952676

Last Updated: 2019-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Moving cupping

Intervention Type DEVICE

1. 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)
2. (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.

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.

Group Type PLACEBO_COMPARATOR

Moving cupping placebo

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Moving cupping

1. 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)
2. (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.

Intervention Type DEVICE

Moving cupping placebo

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shaanxi Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Heilongjiang University of Chinese Medicine

OTHER

Sponsor Role collaborator

Shijiazhuang traditional Chinese medicine hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of JiangXi University of TCM

UNKNOWN

Sponsor Role collaborator

Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jia Zhou

Role: STUDY_CHAIR

Shanghai Yueyang Integrated Medicine Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Site Status

The Affiliated Hospital of Jiangxi University of TCM

Nanchang, Jiangxi, China

Site Status

Shaanxi Provincial Hospital of traditional Chinese Medicine

Xi'an, Shaanxi, China

Site Status

Shijiazhuang traditional Chinese medicine hospital

Shijiazhuang, Shijiazhuang, China

Site Status

Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Ürümqi, Xinjiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bin Li

Role: CONTACT

0086-021-55981301

Xin Li

Role: CONTACT

008613661956326

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Liping Gong

Role: primary

Xiaoning Yan

Role: primary

Linge Li

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32102679 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018YFC1705303

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Natural Gels for Treatment of Plaque Psoriasis
NCT02330237 COMPLETED PHASE2/PHASE3