Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT07254169
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
69 Years
Study:
NCT07254169
Study Brief:
Protocol Section:
NCT07254169