Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03952676|
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Device: Moving cupping Device: Moving cupping placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
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.
- 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.
- 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 (%).
- 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)].
- 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.
- 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.
- 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).
- 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.
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
|Contact: Bin Lifirstname.lastname@example.org|
|Contact: Xin Liemail@example.com|
|First Affiliated Hospital, Heilongjiang University of Chinese Medicine|
|Harbin, Heilongjiang, China|
|The Affiliated Hospital of Jiangxi University of TCM||Not yet recruiting|
|Nanchang, Jiangxi, China|
|Contact: Liping Gong|
|Shaanxi Provincial Hospital of traditional Chinese Medicine||Not yet recruiting|
|Xi'an, Shaanxi, China|
|Contact: Xiaoning Yan|
|Shijiazhuang traditional Chinese medicine hospital||Not yet recruiting|
|Shijiazhuang, Shijiazhuang, China|
|Contact: Linge Li|
|Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital|
|Ürümqi, Xinjiang, China|
|Study Chair:||Jia Zhou||Shanghai Yueyang Integrated Medicine Hospital|