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.
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): 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|