NCT06922565

Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis

Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis: a Multicentre Randomised Sham-controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study used a multicentre parallel three-armed randomised sham-controlled clinical trial methodology in order to objectively and normatively assess the efficacy of acupuncture on Quchi the Sea of Blood the Foot Sanli and the Sanyinjiao in the treatment of moderate-to-severe atopic dermatitis so as to obtain high-level evidence-based medical evidence. This study adopts a multi-centre, parallel, three-armed, randomized, sham-controlled clinical trial method, and will be conducted at Yueyang Hospital of Integrative Medicine affiliated with Shanghai University of Traditional Chinese Medicine, Huashan Hospital affiliated with Fudan University, and Seventh People's Hospital affiliated with Shanghai University of Traditional Chinese Medicine. Eligible patients with moderate-to-severe AD will be divided into three groups using stratified block randomisation in the ratio of 2:2:1: the acupuncture group, the sham-acupuncture group and the waitlisted control group. The total observation period is 9 weeks, including a 1-week introduction period, a 4-week treatment period and a 4-week follow-up period.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	acupuncture	Subjects in the acupuncture group received traditional acupuncture. The needles were inserted to induce a sense of 'getting qi' and left in place for 30 minutes.
DEVICE	sham acupuncture	Sterile disposable retractable needles and a fake placebo acupuncture device are used for sham acupuncture. The acupuncturist attached the base of the sham acupuncture device to the acupoints, and then inserted sterile disposable blunt-tipped retractable needles into the tubes; when the blunt tips touched the skin, the needles retracted into the handles, and there was no sensation of getting qi.

Timeline

• Start date: 2025-04-03
• Primary completion: 2026-06-01
• Completion: 2026-06-30
• First posted: 2025-04-10
• Last updated: 2025-04-10