Plaque Psoriasis Clinical Trial
Official title:
Clinical Evaluation of Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 122 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital, Heilongjiang University of Chinese Medicine | Harbin | Heilongjiang |
China | The Affiliated Hospital of Jiangxi University of TCM | Nanchang | Jiangxi |
China | Shijiazhuang traditional Chinese medicine hospital | Shijiazhuang | Shijiazhuang |
China | Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital | Ürümqi | Xinjiang |
China | Shaanxi Provincial Hospital of traditional Chinese Medicine | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Shanghai Yueyang Integrated Medicine Hospital | Heilongjiang University of Chinese Medicine, Shaanxi Traditional Chinese Medicine Hospital, Shijiazhuang traditional Chinese medicine hospital, The Affiliated Hospital of JiangXi University of TCM, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 56 days after treatment | |
Secondary | 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 (%). | Up to 56 days after treatment | |
Secondary | 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)]. | Up to 56 days after treatment | |
Secondary | 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. | Up to 28 days after treatment | |
Secondary | 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. | Up to 28 days after treatment | |
Secondary | 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). | Up to 56 days after treatment | |
Secondary | CM symptom score | The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 28 days after treatment |
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