None listed
Conditions
Interventions
Medical Device : 224 participants with indications of the eight periocular acupoints, including bilateral GB14, TE23, EX-HN5, and ST1, would be randomly assigned to the BMA treatment group or the ster
Sponsors
Naju Dongshin University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged between 19 and 70 at the screening visit. 2. Patients requiring acupuncture treatment on eight periocular acupoints (bilateral GB14, TE23, ST1, EX-HN5). 3. Patients requiring a total of 12 treatments for 4 weeks (3 times/week). 4. Patients who voluntarily submitted written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a fear of acupuncture or a past history of needle hypersensitivity. 2. Patients with valvular heart disease, pacemakers, or implantable defibrillators. 3. Patients taking medications that may cause hemostatic disorders, including anticoagulants, antiplatelet agents, and aspirin, or who have thrombocytopenia. 4. Patients with skin diseases that may interfere with adverse events monitoring of BMA and sterile acupuncture (mainly face, but not limited to). Examples of skin diseases includes rosacea, atopic dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform rash induced by drugs or cosmetics, bacterial folliculitis, autoimmune diseases, periocular dermatitis, carcinoid syndrome, facial psoriasis, and facial eczema. 5. Patients with adhesive allergy. 6. Patients with dermatologic lesions at the treated acupoints, which may have the risk of acupuncture-related infections. 7. Patients who took medications such as antibiotics, oral corticosteroids, and immunosuppressants within 4 weeks prior to the screening visit. 8. Patients with liver disease, including cirrhosis and liver cancer. 9. Patients with kidney disease, including acute/chronic renal failure and nephrotic syndrome. 10. Patients with acute severe heart disease, including heart failure, myocardial infarction, and stroke. 11. Patients who took antipsychotic medications within 3 months prior to the screening visit. 12. Women who are pregnant, lactating, or planning to become pregnant during the study period. 13. Others deemed inappropriate for participation in this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence (cases) of all adverse events directly related to the treatments during the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: visual analog scale (VAS) for subjective symptoms;Efficacy: quality of life (QoL);Efficacy: ocular surface disease index (OSDI);Efficacy: treatment satisfaction evaluation;Safety: vital signs;Safety: laboratory tests;Safety: Monitoring of adverse events including skin allergy | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hoon Song
Dongshin University
Outcome results
None listed