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

Shanghai Yueyang Integrated Medicine Hospital

Status

Not yet enrolling

Conditions

Atopic Dermatitis

Treatments

Device: sham acupuncture

Device: acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06922565

20250403

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet the diagnostic criteria for moderate to severe atopic dermatitis;
- Age ≥18 and ≤75 years old gender is not limited; ③ Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4; ④ Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

Patients who are in the acute onset of the disease and have erosions exudates and secondary infections;
- Patients who have participated in other clinical studies in the past 3 months or are participating in other clinical studies; ③ Patients with severe haematological diseases (e.g. platelet count <50×109 /L) and other serious diseases that may affect operation and efficacy;
  - Current systematic use of glucocorticosteroids discontinued for less than 7 days; immunosuppressants (cyclosporine methotrexate tretinoin etc.) discontinued for less than 1 month; dulprevirizumab discontinued for less than 1 month JAK inhibitors discontinued for less than 2 weeks;
    - Women who are pregnant or breastfeeding; ⑥ Patients with a history of acupuncture treatment.