Enrolling by invitation
Not applicable
The Efficacy and Safety of Herbal Medicine Treatment Strategy for Patients With Post-Accident Fatigue
Condition(s) studied
Post-traffic Accident Fatigue
Investigational drug(s) / intervention(s)
Herbal medicineEducation
Herbal medicine: 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: 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 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- FSS-K (Fatigue Severity Scale - Korean version) — 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.
Trial sites (1)
| Facility | City | Region | Status |
| Jaseng Hospital of Korean Medicine |
Seoul |
Gangnam-Gu |
|
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