Back to resultsMoving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
Primary Purpose
Plaque Psoriasis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Moving cupping
Moving cupping placebo
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque Psoriasis, Blood stasis syndrome, Randomized controlled trial, Moving cupping
Eligibility Criteria
Inclusion Criteria:
- Diagnostic criteria for plaque psoriasis;
- Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included);
- Aged between 18 and 65 years.
- Consent to participate in the research study and sign the informed consent form
Exclusion Criteria:
- Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis;
- Plaque psoriasis patients with BSA>10%;
- Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
- 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;
- Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing;
- Active infectious disease which was hard to control;
- 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;
- Family history of cancer-prone patients;
- Patients with immunocompromised and can cause skin allergies and infection when moving cupping;
- Pregnant or lactating women;
- Patients with a history of alcohol abuse and drug abuse;
- Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.
Sites / Locations
- First Affiliated Hospital, Heilongjiang University of Chinese Medicine
- The Affiliated Hospital of Jiangxi University of TCM
- Shaanxi Provincial Hospital of traditional Chinese Medicine
- Shijiazhuang traditional Chinese medicine hospital
- Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Moving cupping intervention
Moving cupping placebo control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Psoriasis area and severity index (PASI)
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
Body surface area (BSA)
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 (%).
Physician Global Assessment (PGA)
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)].
Dermatology Life quality index(DLQI)
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.
Patient-reported quality of life (PRQoL)
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.
Visual Analogue Score (VAS)
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).
CM symptom score
The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Full Information
NCT ID
NCT03952676
First Posted
May 15, 2019
Last Updated
May 15, 2019
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT03952676
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yueyang Integrated Medicine Hospital
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Plaque Psoriasis, Blood stasis syndrome, Randomized controlled trial, Moving cupping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moving cupping intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Moving cupping placebo control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Moving cupping
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Moving cupping placebo
Intervention Description
Using of special perforated cups, the manipulation method is the same as the intervention group.
Primary Outcome Measure Information:
Title
Psoriasis area and severity index (PASI)
Description
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.
Time Frame
Up to 56 days after treatment
Secondary Outcome Measure Information:
Title
Body surface area (BSA)
Description
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 (%).
Time Frame
Up to 56 days after treatment
Title
Physician Global Assessment (PGA)
Description
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)].
Time Frame
Up to 56 days after treatment
Title
Dermatology Life quality index(DLQI)
Description
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.
Time Frame
Up to 28 days after treatment
Title
Patient-reported quality of life (PRQoL)
Description
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.
Time Frame
Up to 28 days after treatment
Title
Visual Analogue Score (VAS)
Description
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).
Time Frame
Up to 56 days after treatment
Title
CM symptom score
Description
The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Time Frame
Up to 28 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnostic criteria for plaque psoriasis;
Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included);
Aged between 18 and 65 years.
Consent to participate in the research study and sign the informed consent form
Exclusion Criteria:
Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis;
Plaque psoriasis patients with BSA>10%;
Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
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;
Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing;
Active infectious disease which was hard to control;
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;
Family history of cancer-prone patients;
Patients with immunocompromised and can cause skin allergies and infection when moving cupping;
Pregnant or lactating women;
Patients with a history of alcohol abuse and drug abuse;
Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Li
Phone
0086-021-55981301
Email
18930568129@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Li
Phone
008613661956326
Email
13661956326@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Zhou
Organizational Affiliation
Shanghai Yueyang Integrated Medicine Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
The Affiliated Hospital of Jiangxi University of TCM
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Gong
Facility Name
Shaanxi Provincial Hospital of traditional Chinese Medicine
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoning Yan
Facility Name
Shijiazhuang traditional Chinese medicine hospital
City
Shijiazhuang
State/Province
Shijiazhuang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linge Li
Facility Name
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
City
Ürümqi
State/Province
Xinjiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32102679
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.
Results Reference
derived
Learn more about this trial
Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
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