A Multicentre Randomized Controlled Clinical Study on the Chitosan Nanocrystalline Qinteng Huoxue Runji Ointment Therapy for Psoriasis With Blood Stasis Syndrome. - Trial NCT06396013

Timeline & Enrollment

Primary Outcome

tPASI

Summary

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.

ICD-10 Classifications