NCT03953885

Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome

Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
OTHER	Fire needle	1. Participants wear eye masks and fully expose the lesions. After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation. After selecting an acupuncture needle with a specification of 0.4\*40mm and ignites the alcohol lamp, the operator continuously moves the needle from the needle root to the needle tip to burn the red needle to disinfect the needle in the outer flame of the alcohol lamp. 2. The operator ignites the alcohol lamp, and burns the needle tip and the needle body to the outer flame of the alcohol lamp until it is completely red (the length of the needle burning red is determined by the acupuncture depth), and then rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.
OTHER	Fire needle Placebo	1. Participants wear eye masks and fully expose the lesions (no lesions on the head and face, external genitalia and skin folds). After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation, then selects an acupuncture needle with a specification of 0.4\*40mm to prepare for operation. 2. The operator rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-05-17
• Last updated: 2019-05-17

Locations

5 sites across 1 country: China