Evaluation of Effectiveness and Safety of Korean Herbal Medicine for Post-accident Syndromes After Acute Phase
NCT ID: NCT05494008
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-07-24
2022-09-13
Brief Summary
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Detailed Description
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So, the investigators will conduct a randomized controlled trials to verify the efficacy and safety of Korean herbal medicine. From July, 2021 to May, 2022, the investigators recruited 40 patients who are suffered from post-accident syndromes with the numeric rating scale(NRS) over 5. For experimental group(the Korean herbal medicine treatment group, n=20), the investigators conducted Korean medicine treatment for 4 weeks(28 days), and for control group(the Non-Korean herbal medicine treatment group, n=20), just Korean medical treatment(acupuncture, pharmacoacupuncture, cupping, and chuna) has been conducted. For these two groups, the investigators compared NRS, Impact of Event Scale-Revised-Korean(IES-R-K), 5-level EuroQol 5-dimension(EQ-5D-5L), Short-Form-12 Health Survey version2(SF-12 v2), and Patient Global Impression of Change(PGIC).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Korean herbal medicine treatment
The Korean herbal medicine treatment group received Korean herbal medicine treatment for 28 days. A trained doctor of Korean medicine with at least 3 years of clinical experience prescribed Korean herbal medicine.
The Korean herbal medicine treatment group were also treated with other Korean medical treatment for twice a week for 4 weeks: acupuncture, pharmacoacupuncture, cupping, and chuna.
Korean herbal medicine treatment
Korean 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 with post-traffic accident syndromes.
Non-Korean herbal medicine treatment
The control group received Korean medical treatment for twice a week for 4 weeks: acupuncture, pharmacoacupuncture, cupping and chuna. (except Korean herbal medicine)
Non-Korean herbal medicine treatment
acupuncture, pharmacoacupuncture, cupping, chuna
Interventions
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Korean herbal medicine treatment
Korean 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 with post-traffic accident syndromes.
Non-Korean herbal medicine treatment
acupuncture, pharmacoacupuncture, cupping, chuna
Eligibility Criteria
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Inclusion Criteria
* Patients who have passed more than 8 weeks but less than 24 weeks from the date of the accident on the date they sign the consent form
* Patients with NRS ≥ 5 for post-accident syndromes
* Patients who provide consent to participate in the trial and return the informed consent form
Exclusion Criteria
* Patients who have undergone surgery due to the current traffic accident
* Patients with progressive neurological deficits or with severe neurological symptoms
* Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
* Patients with exceeding twice the normal value in liver function tests and kidney function tests in screening tests
* Patients with kidney or liver/biliary system disease (hepatitis, fatty liver, cirrhosis, liver cancer, biliary obstruction, etc.)
* Patients with gastrointestinal dysfunction or patients who have had a surgery that may affect drug absorption, such as gastrectomy
* Patients who are pregnant or planning to become pregnant
* Patients with a serious mental illness
* Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
* Patients who are difficult to complete the research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic
19 Years
70 Years
ALL
No
Sponsors
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Jaseng Medical Foundation
OTHER
Responsible Party
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In-Hyuk Ha, KMD
Director
Principal Investigators
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In-Hyuk Ha, PhD
Role: PRINCIPAL_INVESTIGATOR
Jaseng Medical Foundation
Locations
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Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea
Countries
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Other Identifiers
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JS-CT-2021-09
Identifier Type: -
Identifier Source: org_study_id