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

February 24, 2026 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, South Korea, 135-896
        • Recruiting
        • Jaseng Hospital of Korean Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adulthood male and female patients with peripheral facial nerve palsy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Facial palsy
Adulthood facial palsy patients group who receive Korean integrative medicine.
Procedure: Korean 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Facial disability index
Time Frame: week 14
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.
week 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Facial disability index (FDI)
Time Frame: week 1, 5, 14, 53
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.
week 1, 5, 14, 53
House-Brackmann facial palsy grade system (HB grade)
Time Frame: week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)
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.
week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)
Numeric rating scale (NRS)
Time Frame: week 1, 5, 14, 53 and every week during treatment
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.
week 1, 5, 14, 53 and every week during treatment
Facial nerve grading system (FNGS 2.0)
Time Frame: week 1, 5, 14, 53
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.
week 1, 5, 14, 53
Synkinesis Assessment Questionnaire (SAQ)
Time Frame: week 1, 5, 14, 53
The SAQ is a questionnaire that calculates the total score of 9 representative symptoms of synkinesis into 1-5 points for each item.
week 1, 5, 14, 53
Patient Global Impression of Change (PGIC)
Time Frame: week 5, 14, 53
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.
week 5, 14, 53
Short Form-12 Health Survey (SF-12)
Time Frame: week 1, 5, 14, 53
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.
week 1, 5, 14, 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaseng Medical Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: In-Hyuk Ha, KMD,Ph.D, Jaseng Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS-CT-2021-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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