- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952676
Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
Clinical Evaluation of Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xin Li
- Phone Number: 008613661956326
- Email: 13661956326@163.com
Study Locations
-
-
Heilongjiang
-
Harbin, Heilongjiang, China
- First Affiliated Hospital, Heilongjiang University of Chinese Medicine
-
-
Jiangxi
-
Nanchang, Jiangxi, China
- The Affiliated Hospital of Jiangxi University of TCM
-
Contact:
- Liping Gong
-
-
Shaanxi
-
Xi'an, Shaanxi, China
- Shaanxi Provincial Hospital of traditional Chinese Medicine
-
Contact:
- Xiaoning Yan
-
-
Shijiazhuang
-
Shijiazhuang, Shijiazhuang, China
- Shijiazhuang traditional Chinese medicine hospital
-
Contact:
- Linge Li
-
-
Xinjiang
-
Ürümqi, Xinjiang, China
- Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
|
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.
|
Using of special perforated cups, the manipulation method is the same as the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 56 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (%).
|
Up to 56 days after treatment
|
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)].
|
Up to 56 days after treatment
|
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).
|
Up to 56 days after treatment
|
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.
|
Up to 28 days after treatment
|
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.
|
Up to 28 days after treatment
|
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.
|
Up to 28 days after treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jia Zhou, Shanghai Yueyang Integrated Medicine Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018YFC1705303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plaque Psoriasis
-
UCB Biopharma SRLRecruitingModerate Chronic Plaque Psoriasis | Severe Chronic Plaque Psoriasis | Mixed Guttate/Plaque PsoriasisUnited States, Canada, Puerto Rico
-
Idera Pharmaceuticals, Inc.CompletedModerate to Severe Plaque Psoriasis | Actively Extending Plaque PsoriasisUnited States
-
Fresenius Kabi SwissBioSim GmbHMerck KGaA, Darmstadt, GermanyCompletedPsoriasis | Moderate to Severe Plaque Psoriasis | Plaque Type PsoriasisUnited States, Canada, Czechia, Hungary, Russian Federation, Bulgaria, Mexico, United Kingdom, Poland, Germany, Estonia, France
-
UCB Biopharma SRLCompletedModerate to Severe Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom
-
Mylan Pharmaceuticals IncMEDA Pharma GmbH & Co. KG; Mylan Inc.; IQVIA Pvt. LtdCompletedHulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and ImmunogenicityModerate Chronic Plaque Psoriasis | Severe Chronic Plaque PsoriasisBulgaria, Czechia, Estonia, Poland
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Canada
-
UCB Biopharma SRLRecruitingModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisChina
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
Clinical Trials on Moving cupping
-
Universität Duisburg-EssenCompletedNeck Pain | Mechanical/Motor Problems With Neck and TrunkGermany
-
Shanghai Yueyang Integrated Medicine HospitalJiangsu Province Hospital of Traditional Chinese Medicine; Wuhan No.1 Hospital and other collaboratorsUnknownPlaque PsoriasisChina
-
Herning HospitalThe Medical Research Fund of the County of RingkøbingCompletedMyocardial Ischemia | Coronary ArteriosclerosisDenmark
-
National Center for Complementary and Alternative...Completed
-
Cairo UniversityUnknown
-
Charite University, Berlin, GermanyHeVaTech GmbHCompleted
-
University of South CarolinaCompletedStiffness; SpineUnited States
-
Universität Duisburg-EssenCompletedNeck Pain | Neck Pain Musculoskeletal | Mechanical/Motor Problems With Neck and TrunkGermany
-
Karabuk UniversityCompletedMigraine Disorders | Migraine Without Aura | Migraine With AuraTurkey
-
University Fernando PessoaCompleted