Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome
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|ClinicalTrials.gov Identifier: NCT03953885|
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Other: Fire needle Other: Fire needle Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Fire needle group
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.
Other: Fire needle
Placebo Comparator: Fire needle placebo group
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.
Other: Fire needle Placebo
- 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 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 (%)
- 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 ]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.
- 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).
- TCM syndrome score [ Time Frame: Up to 56 days after treatment ]The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953885
|Contact: Bin Lifirstname.lastname@example.org|
|Contact: Ting Daiemail@example.com|
|Shijiazhuang Hospital of Traditional Chinese Medicine|
|Shijiazhuang, Hebei, China|
|First Affiliated Hospital of Heilongjiang Chinese Medicine University|
|Ha'erbin, Heilongjiang, China|
|Affiliated hospital of jiangxi university of traditional Chinese medicine|
|Nanchang, Jiangxi, China|
|Shanghai Yueyang Integrated Medicine Hospital|
|Shanghai, Shanghai, China|
|Shanxi Provincial Hospital of Traditional Chinese Medicine|
|Xi'an, Shanxi, China|
|Study Chair:||Jia Zhou||Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai|