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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
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.
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.
University of Medical Center HCMC - Branch no.3
Ho Chi Minh City, Vietnam
Traditional Medicine Hospital of Ho Chi Minh City
Ho Chi Minh City, Vietnam
Changes in Scoring Atopic Dermatitis (SCORAD) score
The SCORAD index is a tool used to assess atopic dermatitis (AD) severity. It combines objective measures of lesion extent and intensity with subjective evaluations of symptoms like pruritus and sleep loss. Calculated using the formula: A/5 + 7B/2 + C, where A represents lesion extent (0-100 points), B rates six objective symptoms (0-18 points), and C measures subjective symptoms on a 10-cm scale (0-20 points), the total score ranges from 0 to 103 with higher scores indicating more severe AD.
Time frame: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
Changes in Dermatology Life Quality Index (DLQI) Score
The DLQI consists of 10 questions assessing patients' perceptions of how skin diseases have affected various aspects of their health-related quality of life over the past week. Each question is scored from 0 to 3 points, resulting in a total DLQI score ranging from 0 to 30. Higher scores indicate a greater impact on quality of life.
Time frame: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
Change in the Number of Antihistamine Tablets Used
The number of antihistamine tablets used per week by patients, as needed to relieve pruritus, is recorded.
Time frame: Weekly throughout the four-week period (Week 1, Week 2, Week 3, Week 4)
Changes in Total Serum Immunoglobulin E (IgE) Levels
Total serum IgE levels are collected in the morning, measured in IU/ml.
Time frame: At randomization and after four weeks (Week 0, Week 4)
Proportion of intervention-related adverse effects (AEs)
Expected AEs for auricular acupuncture include pain at the insertion site, local discomfort, local skin irritation (itching and redness), local inflammation and bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions. Additionally, any unexpected AEs associated with this procedure will also be documented and monitored.
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Time frame: Up to four weeks