NCT07254169

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

November 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

November 20, 2025

Last Update Submit

December 16, 2025

Conditions

Post-traffic Accident Fatigue

Keywords

Fatigue Herbal medicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    Screening, Week 1, Week 3, Week 5, Week 8, Week 12

Secondary Outcomes (10)

  • CFQ-K (Chalder Fatigue Questionnaire - Korean version)

    Week 1, Week 3, Week 5, Week 8, Week 12

  • ISI-K (Insomnia Severity Index - Korean version)

    Week 1, Week 3, Week 5, Week 8, Week 12

  • K-BDI (Beck Depression Inventory - Korean version)

    Week 1, Week 3, Week 5, Week 8, Week 12

  • 5-Level EuroQol-5 Dimension (EQ-5D-5L)

    Week 1, Week 3, Week 5, Week 8, Week 12

  • Body Fat Percentage

    Week 1, Week 3, Week 5, Week 8, Week 12

  • +5 more secondary outcomes

Study Arms (2)

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.

Procedure: Herbal medicineProcedure: 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

Procedure: Education

Interventions

Herbal medicinePROCEDURE

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

Education plus herbal medicine group
EducationPROCEDURE

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.

Education plus herbal medicine groupEducation-only group

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Interventions

PhytotherapyEducational Status

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsSocioeconomic FactorsPopulation Characteristics

Study Officials

  • In-Hyuk Ha, PhD

    Jaseng Medical Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

November 28, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)