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Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03952676
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
Shaanxi Traditional Chinese Medicine Hospital
Heilongjiang University of Chinese Medicine
Shijiazhuang traditional Chinese medicine hospital
The Affiliated Hospital of JiangXi University of TCM
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Device: Moving cupping Device: Moving cupping placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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.
Device: 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.

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.
Device: Moving cupping placebo
Using of special perforated cups, the manipulation method is the same as the intervention group.




Primary Outcome Measures :
  1. Psoriasis area and severity index (PASI) [ Time Frame: Up to 56 days after treatment ]
    Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.


Secondary Outcome Measures :
  1. Body surface area (BSA) [ Time Frame: Up to 56 days after treatment ]
    The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%).

  2. Physician Global Assessment (PGA) [ Time Frame: Up to 56 days after treatment ]
    Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)].

  3. Dermatology Life quality index(DLQI) [ Time Frame: Up to 28 days after treatment ]
    The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life.

  4. Patient-reported quality of life (PRQoL) [ Time Frame: Up to 28 days after treatment ]
    PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life.

  5. Visual Analogue Score (VAS) [ Time Frame: Up to 56 days after treatment ]
    Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis).

  6. CM symptom score [ Time Frame: Up to 28 days after treatment ]
    The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952676


Contacts
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Contact: Bin Li 0086-021-55981301 18930568129@163.com
Contact: Xin Li 008613661956326 13661956326@163.com

Locations
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China, Heilongjiang
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
China, Jiangxi
The Affiliated Hospital of Jiangxi University of TCM Not yet recruiting
Nanchang, Jiangxi, China
Contact: Liping Gong         
China, Shaanxi
Shaanxi Provincial Hospital of traditional Chinese Medicine Not yet recruiting
Xi'an, Shaanxi, China
Contact: Xiaoning Yan         
China, Shijiazhuang
Shijiazhuang traditional Chinese medicine hospital Not yet recruiting
Shijiazhuang, Shijiazhuang, China
Contact: Linge Li         
China, Xinjiang
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Ürümqi, Xinjiang, China
Sponsors and Collaborators
Shanghai Yueyang Integrated Medicine Hospital
Shaanxi Traditional Chinese Medicine Hospital
Heilongjiang University of Chinese Medicine
Shijiazhuang traditional Chinese medicine hospital
The Affiliated Hospital of JiangXi University of TCM
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Investigators
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Study Chair: Jia Zhou Shanghai Yueyang Integrated Medicine Hospital

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Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
ClinicalTrials.gov Identifier: NCT03952676     History of Changes
Other Study ID Numbers: 2018YFC1705303
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:
Plaque Psoriasis
Blood stasis syndrome
Randomized controlled trial
Moving cupping

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases