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| Name | Class |
|---|---|
| Shaanxi Hospital of Traditional Chinese Medicine | OTHER |
| The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine | OTHER |
| Shijiazhuang Hospital of Traditional Chinese Medicine | UNKNOWN |
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This study was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy.
Psoriasis is a chronic inflammatory skin disease characterized by the complex interaction between the immune system, related susceptibility loci, autoantigens and various environmental factors. In China, the prevalence is about 0.47%. Current treatment strategies for psoriasis mainly focus on developing new drugs that disrupt IL-23 or IL-17 cytokine, but this targeted therapy is not effective for all patients. A growing body of evidence indicates that psoriasis-related damage is not limited to the skin, but is closely related to coronary heart disease, stroke, metabolic syndrome, and chronic kidney disease. These comorbidities have, to a certain extent, increased mortality in patients with psoriasis. Traditional Chinese medicine (TCM) has always been used to treat patients with psoriasis in China. Blood stasis syndrome is one of the basic syndromes of psoriasis. which accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for a long time and is similar to many metabolic related diseases. Fire needle therapy is one of the traditional Chinese specialty treatments, which has effects of warming yang to expel cold, warming and activating meridian, dispersing stasis and relieving pain. Studies have shown that fire needle therapy of plaque psoriasis in stationary phase is effective, with fewer side effects, and can reduce the recurrence rate. This multicenter, randomized, single-blind, placebo-controlled trial will objectively and standardly evaluate the clinical effectiveness, safety and control of recurrence of fire needle therapy to obtain objective evidence of international standards and form clinical norms suitable for popularization and application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fire needle group | Experimental | Participants in experimental group will receive Fire needle 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. |
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| Fire needle placebo group | Placebo Comparator | Participants in experimental group will receive Fire needle 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fire needle | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body surface area (BSA) | The percentage of body surface area (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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Li | Contact | 0086-021-55981301 | 18930568129@163.com | |
| Ting Dai | Contact | 0086-021-65161782-3137 | tingdai@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Zhou | Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shijiazhuang Hospital of Traditional Chinese Medicine | Shijiazhuang | Hebei | China | |||
| First Affiliated Hospital of Heilongjiang Chinese Medicine University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32843084 | Derived | Liu L, Lu Y, Yan XN, Yang SQ, Gong LP, Li LE, Zhao YD, Yin QF, Wang RP, An YP, Huang G, Zhang JF, Sun XY, Li X, Li B. Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial. Trials. 2020 Aug 25;21(1):739. doi: 10.1186/s13063-020-04691-7. |
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| Heilongjiang University of Chinese Medicine | OTHER |
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| Fire needle Placebo | Other |
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| 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 |
| 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 |
| Patient-reported quality of life (PRQoL) | Patient-reported quality of life (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 |
| 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 |
| TCM syndrome score | The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 56 days after treatment |
| Harbin |
| Heilongjiang |
| China |
| Affiliated hospital of jiangxi university of traditional Chinese medicine | Nanchang | Jiangxi | China |
| Shanghai Yueyang Integrated Medicine Hospital | Shanghai | Shanghai Municipality | China |
| Shanxi Provincial Hospital of Traditional Chinese Medicine | Xi’an | Shanxi | China |