Post-traffic Accident FatigueTA fatigueNCT07254169
The Efficacy and Safety of Herbal Medicine Treatment Strategy for Patients With Post-Accident Fatigue
A study testing Herbal medicine and Education in people with Post-traffic Accident Fatigue, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This study is a pragmatic randomized controlled pilot clinical trial aimed at evaluating the efficacy and safety of herbal medicine treatment strategy for patients with post-traffic accident fatigue, using an education-only group as the control. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Post-traffic Accident Fatigue
- What is being tested?
- Herbal medicine and Education
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 40 to 69 years.
- Patients who have been in a traffic accident for 12 to 24 weeks.
- Patients with an average score of 4 or higher on the FSS-K questionnaire.
- Participants who voluntarily agreed to participate in the study and signed a consent form.
Who cannot join
- Participants diagnosed with and receiving treatment for a specific disease that may cause fatigue (cancer, anemia, thyroid dysfunction, etc.).
- Participants with clinically significant abnormalities in blood tests that may be a major cause of fatigue.
- Participants taking herbal medicine for fatigue relief or have taken health supplements for fatigue relief within the past two weeks.
- Participants with other chronic conditions that may interfere with the treatment effect or interpretation of results: stroke, myocardial infarction, kidney disease, active hepatitis, diabetic neuropathy, dementia, epilepsy, etc.
- Participants currently taking steroids, immunosuppressants, psychiatric medications, or other medications that may affect the study results.
- Participants who are not suitable for herbal medicine treatment. Unsafe: Patients with conditions that may affect drug intake or absorption, those with digestive problems following surgery related to such conditions, or those with severe liver or kidney disease (AST, ALT, γ-GTP, and serum creatinine levels greater than twice the upper limit of normal during screening).
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- Are pregnant, planning to become pregnant, breastfeeding, or may be pregnant (e.g., recent missed menstrual periods, irregular menstrual cycles, not using contraception, recently had sexual intercourse, or the investigator determines through medical history that pregnancy is possible).
- Participating in research studies other than observational studies without therapeutic intervention.
- Difficulty completing the consent form.
- Other circumstances in which participation in a clinical trial is deemed difficult by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: The Efficacy and Safety of Herbal Medicine Treatment Strategy for Patients With Post-Accident Fatigue: A Pragmatic Randomized Controlled Pilot Clinical Trial
This study is a pragmatic randomized controlled pilot clinical trial aimed at evaluating the efficacy and safety of herbal medicine treatment strategy for patients with post-traffic accident fatigue, using an education-only group as the control.
Read the detailed description
- Background Over three million traffic accidents occur annually across OECD countries, often resulting in fatigue, insomnia, and dizziness that persist beyond the acute phase. Post-accident fatigue is common even after mild injuries and can greatly hinder recovery and daily functioning. In Korean traditional medicine, it is viewed as a deficiency of qi and blood, for which herbal medicine treatment is used to restore vitality. This study aims to assess whether combining herbal medicine with education improves post-accident fatigue and to explore related body composition changes.
- Patient Recruitment and Screening Phase
- Patient Recruitment Forty patients meeting the inclusion/exclusion criteria will be recruited starting from the date of IRB registration. Researchers will use block randomization to allocate participants. After obtaining written consent from patients who meet the criteria, they will be assigned to the study. The probability of assignment to each group will be 1:1.
- Allocation Concealment and Blinding Since blinding is not feasible for this study, it will be conducted as an open-label clinical trial. However, assessor blinding will be implemented. The evaluator, who will not participate in the intervention and will be blinded to group allocation, will conduct assessments in a separate space before the intervention. This role will be performed by a research nurse or a specialist in training.
- Treatment and Evaluation Phase
- Control and Experimental Groups
- The test group will be divided into the "medicinal herbal medicine group," and the control group will be the "education-only group."
- To study the additional effects of herbal medicine treatment while maintaining the same conditions for both groups, both groups will receive educational brochures as follows:
- Subjects in both groups will receive an informational brochure and brief training at their first visit. The brochure will provide information-focused explanations, including the definition and causes of fatigue, post-traumatic fatigue, and the impact of dietary habits and alcohol on fatigue.
- Subjects in both groups will be eligible to receive acupuncture, cupping therapy, pharmacopuncture, and Chuna therapy, if necessary, to treat aftereffects other than fatigue after a traffic accident. The type and method of treatment will be selected within the scope of current clinical practice at the relevant research institution, based on the subject's symptoms and the clinician's judgment. However, herbal medicine treatment aimed at alleviating traffic accident aftereffects will not be permitted during the study period due to concerns about potential confusion with the interventions in this study. - The supplement group will receive additional supplements based on the medical team's diagnosis and take them twice daily for a total of 28 days.
- Study Duration and Observation Points
- The study period for the subjects will be 12 weeks, including a 4-week treatment period and an 8-week follow-up period.
- The baseline will be the study enrollment date (Week 0), and the primary endpoint will be Week 5.
- Data will be collected during the treatment period (Weeks 1 and 3), and the follow-up visits (Weeks 5 (primary endpoint), 8, and 12).
- Data Collection for Evaluation i. Primary Outcome
- (1) FSS-K (Fatigue Severity Scale - Korean version)
- The primary outcome is the FSS-K at Week 5, the end of the treatment intervention.
- The assessment will be conducted at screening, enrollment, and assignment, Weeks 1 and 3 of the treatment period, and at follow-up visits at Weeks 5, 8, and 12. ii. Secondary Outcome
- The following indicators will be assessed at visits during the treatment period (Weeks 1 and 3) and at follow-up visits (Weeks 5 (primary endpoint), 8, and 12).
- (1) CFQ-K (Chalder Fatigue Questionnaire - Korean version)
- (2) ISI-K (Insomnia Severity Index - Korean version)
- (3) K-BDI (Beck Depression Inventory - Korean version)
- (4) Quality of Life Assessment Scale (EQ-5D-5L)
- (5) Body Fat Percentage
- (6) Skeletal Muscle Mass
- (7) Phase Angle
- (8) Extracellular Water Ratio
- (9) Adherence
- (10) Adverse Effects
- Follow-Up Phase After the 4-week treatment period, the subjects will be followed up for 8 weeks to assess symptom changes. Both groups will undergo follow-up visits at 5, 8, and 12 weeks from the date of enrollment, assessing the primary outcome (FSS-K), secondary outcomes (CFQ-K, ISI-K, K-BDI, EQ-5D-5L, body fat percentage, skeletal muscle mass, phase angle, extracellular water content, and medication compliance), and adverse events, identical to those observed during the treatment period. The follow-up period after 5 weeks will have a time window of ±5 days. The follow-up period after 8 and 12 weeks will have a time window of ±7 days. Both groups will undergo blood tests at 5 weeks from the date of enrollment. The blood test items will be identical to those used during the screening period.
- Monitoring The principal investigator or a co-investigator with medical judgment, authorized by the principal investigator, will maintain the integrity of the research data and collect and review safety data for the study subjects. Monitoring will be conducted every six months.
- The safety and rights of the subjects are reported.
- The clinical study is conducted in compliance with the currently approved research protocol and research management standards.
- The data are reliable, accurate, and safe.
- Conditions
- Post-traffic Accident Fatigue
- Being tested
- Herbal medicine, Education
- Keywords
- Fatigue Herbal medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicineProcedure or surgery
Herbal medicine treatment is a treatment using complex extract of medicinal herbs prescribed by a Korean medicine doctor who has completed specialized education to diagnose the health condition and symptoms of patients
EducationProcedure or surgery
Educational materials will be distributed and training will be provided on managing daily life to alleviate fatigue. The information-based program will cover topics such as the definition and causes of fatigue, post-traumatic fatigue, and the impact of dietary habits and alcohol on fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Education plus herbal medicine group | Experimental | An informational booklet will be distributed and a brief training session will be provided at the time of study registration.
The informational booklet will focus on providing information, including the definition and causes of fatigue, post-traumatic fatigue, and the impact of dietary habits and alcohol on fatigue.
If necessary, acupuncture, moxibustion, herbal acupuncture, and Chuna therapy can be provided for post-traumatic treatment of other aftereffects besides fatigue. Receives: Procedure: Herbal medicine; Procedure: Education |
| Education-only group | Active comparator | At the time of study registration, informational pamphlets will be distributed and brief training will be provided.
If necessary, acupuncture, cupping therapy, herbal acupuncture, and Chuna therapy can be provided to treat aftereffects other than fatigue after a traffic accident.
The clinician will prescribe a 14-day supply of herbal medicine based on the patient's diagnosis. Subjects in the herbal medicine group will take the herbal medicine orally twice daily for a total of 28 days during the treatment period.
This study is a practical clinical trial and has no restrictions on the type of herbal medicine used. Prescriptions are made at the discretion of the medical staff, with the primary goal of alleviating fatigue. All prescriptions are written by a Korean medicine doctor with at least five years of clinical experience. After the prescriptions are issued, the herbal medicines are delivered to the participants via courier and consumed. Participants are instructed to store all herba Receives: Procedure: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSS-K (Fatigue Severity Scale - Korean version)
The FSS-K assesses fatigue levels over the past week on a scale of 1 to 7, with nine questions. The final FSS score is calculated by adding the scores for each item and dividing by 9, resulting in an average. Higher scores indicate greater fatigue.
Measured: Screening, Week 1, Week 3, Week 5, Week 8, Week 12
Secondary outcomes (10)
CFQ-K (Chalder Fatigue Questionnaire - Korean version)
The CFQ-K is a 14-item self-report scale divided into two domains: physical fatigue symptoms (8 items) and mental fatigue symptoms (6 items). Each item has five response options ('none', 'better than usual', 'as usual', 'worse than usual', 'very bad') and is scored from 0 to 4. Each subscale score is calculated by summing the scores of all items in that domain, and the overall fatigue score is calculated by summing the scores of all 14 items, with higher scores indicating more severe fatigue.
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
ISI-K (Insomnia Severity Index - Korean version)
ISI-K is a questionnaire that evaluates the severity of insomnia and consists of 5 questions, each of which is scored from 0 (no insomnia) to 4 (most severe insomnia).
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
K-BDI (Beck Depression Inventory - Korean version)
The K-BDI consists of 21 items covering the cognitive, emotional, motivational, and physical symptom domains of depressive symptoms. Each item consists of four options describing the severity of depressive symptoms. Scores range from 0 (1) to 3 (4), and each item's score is summed to obtain a total score. Scores range from 0 to 63.
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
5-Level EuroQol-5 Dimension (EQ-5D-5L)
The 5-Level EuroQol-5 Dimension (EQ-5D-5L) is one of the most widely used indirect measurement methods for calculating the quality weight of a specific health state. It evaluates health status from multiple perspectives and utilizes pre-assigned preference scores for each functional level to indirectly calculate the quality weight of a particular health condition. The EQ-5D-5L consists of five items, each addressing the degree of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is assigned a specific weight based on its level, and a preference score calculation formula is provided using these weights and constants.
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
Body Fat Percentage
This refers to the percentage of body fat relative to body weight. Obesity is more appropriately assessed by the percentage of body fat relative to body weight than by the actual body fat mass. For men, the standard body fat percentage is 15% of standard body weight, and for women, it is 23% of standard body weight.
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
Skeletal muscle mass
This is the amount of muscle attached to the skeleton, excluding involuntary muscles such as visceral muscles.
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
Phase Angle
This represents the resistance across the cell membrane, expressed as an angle. The higher the structural stability of the cell, the higher the value. A healthy cell exhibits a high value, while a deteriorating cell membrane condition results in a value closer to 0.
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
Extracellular Water Ratio
This represents the ratio of intracellular water (ICW) to extracellular water (ECW), indicating body water balance. The standard range is 0.36 to 0.39.
Measured: Week 1, Week 3, Week 5, Week 8, Week 12
Adherence
To assess treatment compliance, for participants in the herbal medicine treatment group, the cumulative number of herbal medicine packs prescribed and the number of unused herbal medicine packs are recorded in the CRF for those receiving supplements at Week 5.
Measured: Week 5
Adverse Event (AE)
An adverse event refers to any undesirable and unintended objective sign, subjective symptom, or disease that occurs after a clinical trial procedure, and it does not necessarily have to have a causal relationship with the procedure. During the study period, adverse events are collected through participants' symptom reports and researchers' observations, and the type of adverse event along with its causal relationship to the intervention is recorded in the Electronic Medical Record (EMR). In case of an adverse event, follow-up monitoring is conducted, and any severe adverse event is promptly reported. The causality of adverse events is classified into six levels based on the WHO-UMC causality categories: Certain (1), Probable/Likely (2), Possible (3), Unlikely (4), Conditional/Unclassified (5), and Unassessable/Unclassifiable (6).
Measured: Week 3, Week 5, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start13 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traffic Accident FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, PhD, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254169
- Sponsor's protocol ID
- JS-CT-2025-12
- Other IDs
- Jaseng Medical Foundation
- Acronym
- TA fatigue
- Status last verified
- May 2026
- First submitted
- 20 Nov 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Herbal Medicine Treatment Strategy for Patients With Post-Accident Fatigue: A Pragmatic Randomized Controlled Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07254169
- Acronym / sponsor ID
- TA fatigue / JS-CT-2025-12
- Conditions
- Post-traffic Accident Fatigue
- Keywords
- Fatigue Herbal medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pragmatic randomized controlled pilot clinical trial aimed at evaluating the efficacy and safety of herbal medicine treatment strategy for patients with post-traffic accident fatigue, using an education-only group as the control.
Detailed description
- Background Over three million traffic accidents occur annually across OECD countries, often resulting in fatigue, insomnia, and dizziness that persist beyond the acute phase. Post-accident fatigue is common even after mild injuries and can greatly hinder recovery and daily functioning. In Korean traditional medicine, it is viewed as a deficiency of qi and blood, for which herbal medicine treatment is used to restore vitality. This study aims to assess whether combining herbal medicine with education improves post-accident fatigue and to explore related body composition changes.
- Patient Recruitment and Screening Phase
- Patient Recruitment Forty patients meeting the inclusion/exclusion criteria will be recruited starting from the date of IRB registration. Researchers will use block randomization to allocate participants. After obtaining written consent from patients who meet the criteria, they will be assigned to the study. The probability of assignment to each group will be 1:1.
- Allocation Concealment and Blinding Since blinding is not feasible for this study, it will be conducted as an open-label clinical trial. However, assessor blinding will be implemented. The evaluator, who will not participate in the intervention and will be blinded to group allocation, will conduct assessments in a separate space before the intervention. This role will be performed by a research nurse or a specialist in training.
- Treatment and Evaluation Phase
- Control and Experimental Groups
- The test group will be divided into the "medicinal herbal medicine group," and the control group will be the "education-only group."
- To study the additional effects of herbal medicine treatment while maintaining the same conditions for both groups, both groups will receive educational brochures as follows:
- Subjects in both groups will receive an informational brochure and brief training at their first visit. The brochure will provide information-focused explanations, including the definition and causes of fatigue, post-traumatic fatigue, and the impact of dietary habits and alcohol on fatigue.
- Subjects in both groups will be eligible to receive acupuncture, cupping therapy, pharmacopuncture, and Chuna therapy, if necessary, to treat aftereffects other than fatigue after a traffic accident. The type and method of treatment will be selected within the scope of current clinical practice at the relevant research institution, based on the subject's symptoms and the clinician's judgment. However, herbal medicine treatment aimed at alleviating traffic accident aftereffects will not be permitted during the study period due to concerns about potential confusion with the interventions in this study. - The supplement group will receive additional supplements based on the medical team's diagnosis and take them twice daily for a total of 28 days.
- Study Duration and Observation Points
- The study period for the subjects will be 12 weeks, including a 4-week treatment period and an 8-week follow-up period.
- The baseline will be the study enrollment date (Week 0), and the primary endpoint will be Week 5.
- Data will be collected during the treatment period (Weeks 1 and 3), and the follow-up visits (Weeks 5 (primary endpoint), 8, and 12).
- Data Collection for Evaluation i. Primary Outcome
- (1) FSS-K (Fatigue Severity Scale - Korean version)
- The primary outcome is the FSS-K at Week 5, the end of the treatment intervention.
- The assessment will be conducted at screening, enrollment, and assignment, Weeks 1 and 3 of the treatment period, and at follow-up visits at Weeks 5, 8, and 12. ii. Secondary Outcome
- The following indicators will be assessed at visits during the treatment period (Weeks 1 and 3) and at follow-up visits (Weeks 5 (primary endpoint), 8, and 12).
- (1) CFQ-K (Chalder Fatigue Questionnaire - Korean version)
- (2) ISI-K (Insomnia Severity Index - Korean version)
- (3) K-BDI (Beck Depression Inventory - Korean version)
- (4) Quality of Life Assessment Scale (EQ-5D-5L)
- (5) Body Fat Percentage
- (6) Skeletal Muscle Mass
- (7) Phase Angle
- (8) Extracellular Water Ratio
- (9) Adherence
- (10) Adverse Effects
- Follow-Up Phase After the 4-week treatment period, the subjects will be followed up for 8 weeks to assess symptom changes. Both groups will undergo follow-up visits at 5, 8, and 12 weeks from the date of enrollment, assessing the primary outcome (FSS-K), secondary outcomes (CFQ-K, ISI-K, K-BDI, EQ-5D-5L, body fat percentage, skeletal muscle mass, phase angle, extracellular water content, and medication compliance), and adverse events, identical to those observed during the treatment period. The follow-up period after 5 weeks will have a time window of ±5 days. The follow-up period after 8 and 12 weeks will have a time window of ±7 days. Both groups will undergo blood tests at 5 weeks from the date of enrollment. The blood test items will be identical to those used during the screening period.
- Monitoring The principal investigator or a co-investigator with medical judgment, authorized by the principal investigator, will maintain the integrity of the research data and collect and review safety data for the study subjects. Monitoring will be conducted every six months.
- The safety and rights of the subjects are reported.
- The clinical study is conducted in compliance with the currently approved research protocol and research management standards.
- The data are reliable, accurate, and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education plus herbal medicine group | Experimental | Procedure: Herbal medicine, Procedure: EducationAn informational booklet will be distributed and a brief training session will be provided at the time of study registration. The informational booklet will focus on providing information, including the definition and causes of fatigue, post-traumatic fatigue, and the impact of dietary habits and alcohol on fatigue. If necessary, acupuncture, moxibustion, herbal acupuncture, and Chuna therapy can be provided for post-traumatic treatment of other aftereffects besides fatigue. |
| Education-only group | Active comparator | Procedure: EducationAt the time of study registration, informational pamphlets will be distributed and brief training will be provided. If necessary, acupuncture, cupping therapy, herbal acupuncture, and Chuna therapy can be provided to treat aftereffects other than fatigue after a traffic accident. The clinician will prescribe a 14-day supply of herbal medicine based on the patient's diagnosis. Subjects in the herbal medicine group will take the herbal medicine orally twice daily for a total of 28 days during the treatment period. This study is a practical clinical trial and has no restrictions on the type of herbal medicine used. Prescriptions are made at the discretion of the medical staff, with the primary goal of alleviating fatigue. All prescriptions are written by a Korean medicine doctor with at least five years of clinical experience. After the prescriptions are issued, the herbal medicines are delivered to the participants via courier and consumed. Participants are instructed to store all herba |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 40 to 69 years.
- Patients who have been in a traffic accident for 12 to 24 weeks.
- Patients with an average score of 4 or higher on the FSS-K questionnaire.
- Participants who voluntarily agreed to participate in the study and signed a consent form.
Key exclusion criteria (10 listed)
- Participants diagnosed with and receiving treatment for a specific disease that may cause fatigue (cancer, anemia, thyroid dysfunction, etc.).
- Participants with clinically significant abnormalities in blood tests that may be a major cause of fatigue.
- Participants taking herbal medicine for fatigue relief or have taken health supplements for fatigue relief within the past two weeks.
- Participants with other chronic conditions that may interfere with the treatment effect or interpretation of results: stroke, myocardial infarction, kidney disease, active hepatitis, diabetic neuropathy, dementia, epilepsy, etc.
- Participants currently taking steroids, immunosuppressants, psychiatric medications, or other medications that may affect the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal medicineHerbal medicine treatment is a treatment using complex extract of medicinal herbs prescribed by a Korean medicine doctor who has completed specialized education to diagnose the health condition and symptoms of patients | Procedure or surgery | Education plus herbal medicine group |
| EducationEducational materials will be distributed and training will be provided on managing daily life to alleviate fatigue. The information-based program will cover topics such as the definition and causes of fatigue, post-traumatic fatigue, and the impact of dietary habits and alcohol on fatigue. | Procedure or surgery | Education plus herbal medicine group, Education-only group |
Primary outcome
FSS-K (Fatigue Severity Scale - Korean version)
Time frame: Screening, Week 1, Week 3, Week 5, Week 8, Week 12
The FSS-K assesses fatigue levels over the past week on a scale of 1 to 7, with nine questions. The final FSS score is calculated by adding the scores for each item and dividing by 9, resulting in an average. Higher scores indicate greater fatigue.
10 secondary outcomes
CFQ-K (Chalder Fatigue Questionnaire - Korean version)
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
ISI-K (Insomnia Severity Index - Korean version)
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
K-BDI (Beck Depression Inventory - Korean version)
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
5-Level EuroQol-5 Dimension (EQ-5D-5L)
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
Body Fat Percentage
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
Skeletal muscle mass
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
Phase Angle
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
Extracellular Water Ratio
Time frame: Week 1, Week 3, Week 5, Week 8, Week 12
Adherence
Time frame: Week 5
Adverse Event (AE)
Time frame: Week 3, Week 5, Week 8, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In-Hyuk Ha, PhD principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal medicine and Education in people with Post-traffic Accident Fatigue, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSS-K (Fatigue Severity Scale - Korean version) (time frame: Screening, Week 1, Week 3, Week 5, Week 8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.