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Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
First Affiliated Hospital of Heilongjiang Chinese Medicine University
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
Start Date
June 1, 2019
Primary Completion Date
December 31, 2021
Completion Date
December 31, 2021
Last Updated
May 17, 2019
92
ESTIMATED participants
Fire needle
OTHER
Fire needle Placebo
OTHER
Lead Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
NCT07116967
NCT07250802
NCT07449702
Data Source & Attribution
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