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RecruitingNCT04905745Updated Feb 25, 2026

The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy

An observational study in Facial Paralysis, Peripheral, sponsored by Jaseng Medical Foundation. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Jaseng Medical Foundation · Observational

From the registry’s dates

  • Started May 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
19 Years to 69 Years
Sex
All
01

Study summary

This is an observational study that evaluate the effectiveness and safety of Korean integrative treatments in patients with peripheral facial nerve palsy. Adulthood patients aged between 19 to 69 who were diagnosed with peripheral facial nerve palsy and receive Korean integrative treatments for facial palsy will be enrolled in the study and the change will be followed according to the Facial disability index (FDI) at the 3 month moment after baseline.

Read the detailed description

This is an observational study that evaluate the effectiveness and safety of Korean integrative treatments in patients with peripheral facial nerve palsy. A total of 100 patients who are in age of from 19 to 69, diagnosed with peripheral facial nerve palsy, in acute to subacute stage, and who receive Korean integrative treatments for facial palsy will be enrolled in this study. This study is an observational study and the intervention will be decided not by researchers, but by physicians in the real clinical practice. The treatment will be entirely determined according to each subject's medical conditions by an experienced clinician who has received more than 6 years of education and more than 3 years of training. This study will only record the contents of the intervention. Among all the data generated during the study period, data deemed necessary can be collected in the case record forms. The intervention will also be determined by the clinician, and the researcher presented assessment and data collection timepoints, which is independent of the treatment schedule. The on-treatment visit schedule will be once a week during the treatment is ongoing, and follow-up visit schedule will be on the 5th, 14th, and 53rd weeks after the baseline.

02

Conditions studied

  • Facial Paralysis, Peripheral

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03

In context

Facial Paralysis

81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 21 observational studies indexed under Facial Paralysis.

Browse Facial Paralysis studies →

Lead sponsor

Jaseng Medical Foundation is the lead sponsor of 69 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adulthood male and female patients with peripheral facial nerve palsy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 form and the questionnaires.
  10. difficult to participate according to the judgement of researchers.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Facial palsy

    Adulthood facial palsy patients group who receive Korean integrative medicine.

    Procedure: Korean integrative medicine

Interventions

  • ProcedureKorean integrative medicine

    Any kind of Korean integrative medicine will be applicable and the treatment will be entirely determined by experienced clinicians. On the premise of the above, the following examples are the treatments applicable to the subject of this observational study. * Chuna: Chuna therapy is performed on the face and cervical spine to induce decompression of the captured facial nerve. In addition, SJS Non-Resistance Technique-Facial palsy (SJS NRT-F), a technique of Chuna, can be performed to stimulate the intrinsic receptive sensation of the facial muscles to promote the neuromuscular response. * Acupuncture: acupuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status. * Pharmacopuncture: pharmacopuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status. * Herbal medicine: It is prescribed according to clinical judgment according to the patient's symptoms and disease status.

06

What researchers measure

Primary outcomes

  1. Facial disability index

    This is a questionnaire made to evaluate the subjective sensations of patients on the ability to use facial muscles and their emotional state. It is composed of 10 items, and 1-5 is composed of 5 points per item for movement state, and 6-10 is composed of 6 points per item for sociological state and emotional state.

    Time frame: week 14

Secondary outcomes

  1. Facial disability index (FDI)

    This is a questionnaire made to evaluate the subjective sensations of patients on the ability to use facial muscles and their emotional state. It is composed of 10 items, and 1-5 is composed of 5 points per item for movement state, and 6-10 is composed of 6 points per item for sociological state and emotional state.

    Time frame: week 1, 5, 14, 53

  2. House-Brackmann facial palsy grade system (HB grade)

    HB grade is a scale to evaluate facial palsy into 6 stages based on the severity of facial palsy, especially the muscles around the mouth and the muscles arount the eyes.

    Time frame: week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)

  3. Numeric rating scale (NRS)

    NRS is a 11-point scale of 0-10. the researcher will rate NRS for postauricular pain and discomforts in the face and cervical area.

    Time frame: week 1, 5, 14, 53 and every week during treatment

  4. Facial nerve grading system (FNGS 2.0)

    FNGS 2.0 is calculated based on the total score by section by section in facial part and additional score with synkinesis movement. The result of FNGS 2.0 well indicate the palsy status, with the grade of 1-6 and 4-24 points.

    Time frame: week 1, 5, 14, 53

  5. Synkinesis Assessment Questionnaire (SAQ)

    The SAQ is a questionnaire that calculates the total score of 9 representative symptoms of synkinesis into 1-5 points for each item.

    Time frame: week 1, 5, 14, 53

  6. Patient Global Impression of Change (PGIC)

    Patient global impression of change (PGIC) is a method that allows the patient to subjectively evaluate the degree of improvement in 7 degree of scale.

    Time frame: week 5, 14, 53

  7. Short Form-12 Health Survey (SF-12)

    The SF-12 is a questionnaire that evaluates the overall health-related quality of lives (HRQoL). SF-12 consists of 12 questions covering following 8 areas, to evaluate functional health and well-being of individuals both ill and healthy; physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.

    Time frame: week 1, 5, 14, 53

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2021 (actual). Primary completion is estimated for Aug 2027, 75 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2021
First posted
May 28, 2021
StartActual
May 25, 2021
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Feb 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04905745
Lead sponsor
Jaseng Medical Foundation
Responsible party
In-Hyuk Ha, KMD (Director of Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation) — Principal investigator
First posted
May 28, 2021
Start date
May 25, 2021
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Feb 25, 2026

Study contacts

In-Hyuk Ha, KMD,Ph.D
Contact
hanihata@gmail.com
+82-2-2222-2740
In-Hyuk Ha, KMD,Ph.D
study director · Jaseng Medical Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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