NCT06492902

Adding Auricular Acupuncture to Xiao-Feng-San Decoction for Treating Atopic Dermatitis

Efficacy of Adding Auricular Acupuncture to Xiao-Feng-San for Treating Atopic Dermatitis Exhibiting Wind-Dampness-Heat Manifestations According to Traditional Medicine: A Multi-Center, Double-Blinded, Randomized, Sham-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the efficacy of adding auricular acupuncture to Xiao-Feng-San decoction versus Xiao-Feng-San decoction in treating atopic dermatitis. The trial is a multi-center, double-blinded, randomized, sham-controlled study.

Detailed description

Atopic dermatitis (AD) is a chronic inflammatory skin condition that affects a significant number of individuals worldwide. In Traditional Medicine (TM), Xiao-Feng-San (XFS), a TM formula, has been widely used in the treatment of mild to moderate AD exhibiting wind-dampness-heat manifestations. This study aims to investigate whether the addition of auricular acupuncture (AA), a form of acupuncture targeting points on the ear, enhances the efficacy of XFS in treating AD. The trial is a multi-center, double-blinded, randomized, sham-controlled study involving participants diagnosed with mild to moderate AD exhibiting wind-dampness-heat manifestations according to TM and indicated for the use of XFS decoction. Participants will be randomly assigned to receive either AA or sham AA (placebo) in addition to XFS. Outcome measures will include the severity of AD symptoms, quality of life assessments, the need for antipruritic medication, total serum immunoglobulin E (IgE) levels, and adverse effects. Through rigorous methodology and blinding procedures, this study seeks to provide evidence on the comparative efficacy of adjunct AA in enhancing the therapeutic effects of XFS for AD. The findings aim to contribute valuable insights into optimizing treatment strategies for AD using integrative approaches.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	Auricular acupuncture	Auricular acupuncture is conducted weekly in four weeks using patches (four sessions), each with a square shape and a side length of 10 mm, along with sterilized needles measuring 0.25 x 1.3 mm. The patch with the needle will remain in place for one week.
OTHER	Sham auricular acupuncture	Sham auricular acupuncture is conducted weekly for four weeks using patches (four sessions), each with a square shape and a side length of 10 mm. The patches will not contain any needles and will remain in place for one week.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-03-23
• Completion: 2025-03-23
• First posted: 2024-07-09
• Last updated: 2025-03-26

Locations

2 sites across 1 country: Vietnam