The Efficacy and Safety of Herbal Medicine Treatment Strategy for Patients With Post-Accident Fatigue: A Pragmatic Randomized Controlled Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- FSS-K (Fatigue Severity Scale - Korean version)
研究概览
简要总结
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.
详细描述
0. 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.
1. 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.
2. Treatment and Evaluation Phase
- Control and Experimental Groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Education plus herbal medicine group
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.
干预措施: Herbal medicine (Procedure)
Education plus herbal medicine group
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.
干预措施: Education (Procedure)
Education-only group
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
干预措施: Education (Procedure)
结局指标
主要结局
FSS-K (Fatigue Severity Scale - Korean version)
时间窗: 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.
FSS-K (Fatigue Severity Scale - Korean version)
时间窗: 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.
次要结局
- Skeletal muscle mass(Week 1, Week 3, Week 5, Week 8, Week 12)
- 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)
- Phase Angle(Week 1, Week 3, Week 5, Week 8, Week 12)
- Extracellular Water Ratio(Week 1, Week 3, Week 5, Week 8, Week 12)
- Adherence(Week 5)
- Adverse Event (AE)(Week 3, Week 5, Week 8, Week 12)
- 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)
- Skeletal muscle mass(Week 1, Week 3, Week 5, Week 8, Week 12)
- Phase Angle(Week 1, Week 3, Week 5, Week 8, Week 12)
- Extracellular Water Ratio(Week 1, Week 3, Week 5, Week 8, Week 12)
- Adherence(Week 5)
- Adverse Event (AE)(Week 3, Week 5, Week 8, Week 12)