Background: Psoriasis is one of the hot spots in the field of skin disease prevention and treatment, and TCM topical preparations have unique advantages in the treatment of psoriasis. The Qinteng Huoxue prescription series of TCM topical preparations created by Professor Sun Liyun have been observed to be effective in clinical practice in the treatment of psoriasis, but there is no multi-center clinical trial for blood stasis syndrome. In addition, the TCM topical preparations has the disadvantages of large particle diameter and unfavorable penetration of skin barrier. Objective: In this study, chitosan nanocrystalline drug delivery system was used to prepare Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, and the efficacy and safety of Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment in the intervention of psoriasis with blood stasis syndrome was investigated through multi-center, randomized, double-blind, self-controlled bilateral skin lesions and placebo-controlled clinical trials. Methods: A total of 96 patients with plaque psoriasis with blood stasis syndrome of were enrolled in 4 research centers, and bilateral symmetrical rashes on limbs or trunk were selected, and randomly divided into experimental group and control group. The experimental group received topical Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment, twice a day for 12 weeks, and the control group received topical placebo twice a day for 12 weeks, and two follow-up visits were performed at the 16th and 20th week. Results Indicators: The main efficacy indicators were targeted psoriasis area and severity index (tPASI), and the secondary efficacy indicators included: Psoriasis physician global assessment (PGA), target lesion area, numerical rating scale (NRS), TCM syndrome score, dermatology life quality index (DLQI), MOS 36 item short from health survey (SF-36)), and the morphology and number of vascular globules under dermoscopy. tPASI, PGA, target lesion area, NRS were assessed at baseline, at 2, 4, 6, 8, 10, 12 weeks of treatment, and at 16 and 20 weeks of follow-up. TCM syndrome score, DLQI, SF-36, and dermoscopy were assessed at baseline, 12 and 20 weeks. Safety assessment includes vital signs monitoring, blood routine, urine routine, liver and kidney function tests, and adverse events and adverse reactions. SPSS 20.0 was used for data analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Basic treatment: According to the recommendations of the Guidelines, all participant took the traditional Chinese medicine decoction Huoxue Sanyu Decoction orally. 2 times/day for 12 weeks. Acute administration: When the participant has unbearable itching, the doctor can give loratadine tablet 10mg orally once a night, and record the dosage and frequency of use.
Basic treatment: According to the recommendations of the Guidelines, all participant took the traditional Chinese medicine decoction Huoxue Sanyu Decoction orally. 2 times/day for 12 weeks. Acute administration: When the participant has unbearable itching, the doctor can give loratadine tablet 10mg orally once a night, and record the dosage and frequency of use.
tPASI
targeted psoriasis area and severity index
Time frame: week0 2 4 6 8 10 12 16 20
PGA
physician global assessment
Time frame: week0 2 4 6 8 10 12 16 20
target lesion area
target lesion area
Time frame: week0 2 4 6 8 10 12 16 20
NRS
numerical rating scale
Time frame: week0 2 4 6 8 10 12 16 20
TCM syndrome score
TCM syndrome score
Time frame: week0 12 20
DLQI
dermatology life quality index
Time frame: week0 12 20
SF-36
MOS 36 item short from health survey
Time frame: week0 12 20
the morphology and number of vascular globules under dermoscopy
the morphology and number of vascular globules under dermoscopy
Time frame: week0 12 20
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