Evaluating Korean medicine for treating Bell's palsy
The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study
This study is testing if Korean medicine can help adults with Bell's palsy improve their facial function and overall condition over three months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 69 Years |
| Sex | All |
| Sponsor | Jaseng Medical Foundation Academic / other |
| Locations | 1 site (Seoul, Gangnam-Gu) |
| Trial ID | NCT04905745 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the effectiveness and safety of Korean integrative treatments in patients diagnosed with peripheral facial nerve palsy. A total of 100 adult participants, aged 19 to 69, will be enrolled and monitored for changes in their condition using the Facial Disability Index (FDI) over a three-month period. The treatment approach will be tailored by experienced clinicians based on individual patient needs, with weekly visits during treatment and follow-up assessments at specified intervals. Data will be collected to evaluate the outcomes of the interventions provided.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 69 who have been diagnosed with unilateral peripheral facial nerve palsy within the last three weeks.
Not a fit: Patients with central nervous system diseases or those who have received significant prior treatments for facial paralysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for patients suffering from Bell's palsy.
How similar studies have performed: While this approach is relatively novel, other studies have explored integrative medicine for various conditions, showing promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age of 19 to 69 2. diagnosed with unilateral peripheral facial nerve palsy 3. onset of facial palsy within 3 weeks or less. 4. an individual who can provide written consent form to participate in the study. Exclusion Criteria: 1. diagnosed with central nervous system disease causing facial palsy 2. secondary facial palsy after multiple sclerosis, tumor, cerebrovascular disease and temporal bone fracture. 3. Ramsay-Hunt syndrome 4. bilateral or recurrent facial nerve palsy. 5. an individual who received any treatment that can have a significant effect on changes in facial paralysis within recent 2 month. (ie. facial nerve decompression surgery) 6. already or planned to be pregnant or breast-feeding within the study period. 7. uncontrolled diabetes mellitus within the last 3 months. 8. within a month after participating any other facial palsy-related clinical trials, or planning to participate other clinical trials within 6 month. 9. impossible to read and understand the documents, regarding informed consent form and the questionnaires. 10. difficult to participate according to the judgement of researchers.
Where this trial is running
Seoul, Gangnam-Gu
- Jaseng Hospital of Korean Medicine — Seoul, Gangnam-Gu, South Korea (Recruiting)
Study contacts
- Study coordinator: In-Hyuk Ha, KMD,Ph.D
- Email: hanihata@gmail.com
- Phone: +82-2-2222-2740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.