Traffic AccidentNCT05494008
Evaluation of Effectiveness and Safety of Korean Herbal Medicine for Post-accident Syndromes After Acute Phase
A study testing Korean herbal medicine treatment and Non-Korean herbal medicine treatment in people with Traffic Accident and Whiplash Syndrome, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This study is a single blind, randomized controlled trail. condition/disease: Post-accident syndromes after acute phase treatment/intervention: herbal medicine treatment strategy Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Traffic Accident, Whiplash Syndrome
- What is being tested?
- Korean herbal medicine treatment and Non-Korean herbal medicine treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2021to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19-70 years on the date they sign the consent form
- 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
Who cannot join
- Patients whose pain is not due to a traffic accident but due to an existing disease (hernia of intervertebral discs, spinal canal stenosis, fibromyalgia, etc.)
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Evaluation of Effectiveness and Safety of Korean Herbal Medicine Treatment Strategy for Outpatients With Post-accident Syndromes After Acute Phase: A Pilot Pragmatic Randomized Controlled Trial
This study is a single blind, randomized controlled trail. condition/disease: Post-accident syndromes after acute phase treatment/intervention: herbal medicine treatment strategy
Read the detailed description
The Korean herbal medicine is a 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. This treatment is known to relieve the post-accident syndromes and improve health. However, there are no studies examining the efficacy of Korean herbal medicine alone.
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
- Traffic Accident, Whiplash Syndrome
- Being tested
- Korean herbal medicine treatment, Non-Korean herbal medicine treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean herbal medicine treatmentProcedure or surgery
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 treatmentProcedure or surgery
acupuncture, pharmacoacupuncture, cupping, chuna
| Study group | Role | What they receive |
|---|---|---|
| Korean herbal medicine treatment | Experimental | 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. Receives: Procedure: Korean herbal medicine treatment |
| Non-Korean herbal medicine treatment | Active comparator | The control group received Korean medical treatment for twice a week for 4 weeks: acupuncture, pharmacoacupuncture, cupping and chuna. (except Korean herbal medicine) Receives: Procedure: Non-Korean herbal medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale(NRS) of post-accident syndromes
The severity of post-accident syndrome will be assessed using NRS. NRS is a scale in which the patient indicates their subjective severity of symptoms as a whole number from 0 to 10. The participant is asked to report their severity of post-accident syndrome using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: Change from baseline to 4 months
Secondary outcomes (12)
Numeric Rating Scale(NRS) of musculoskeletal complaints of post-accident syndromes
The severity of musculoskeletal complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of musculoskeletal complaints(post neck pain, lower back pain, shoulder pain, knee pain, etc) using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain or discomfort imaginable'.
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of neurological complaints of post-accident syndromes
The severity of neurological complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of neurological complaints(headache, dizziness, etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'.
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of psychiatric complaints of post-accident syndromes
The severity of psychiatric complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of psychiatric complaints(anxiety, depression, anger, insomnia etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'.
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of digestive systemic complaints of post-accident syndromes
The severity of digestive systemic complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of digestive systemic complaints(indigestion, loss of appetite, etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'.
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of general symptoms of post-accident syndromes
The severity of general symptoms of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of general symptoms(fatigue, powerlessness, etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'.
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Impact of Event Scale-Revised-Korean (IES-R-K)
The IES-R-K is a 22-item self-report scale that evaluates subjective stress caused by traumatic events. Each item is rated on a scale of 0 (not at all) to 4 (extremely) of the severity of symptoms based on the past week, with a total score ranging from 0 to 88. Although it is not generally recommended for the diagnosis of PTSD, it is an evaluation scale widely used in trauma-related clinical studies.
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
5-level EuroQol 5-dimension (EQ-5D-5L)
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Short-Form-12 Health Survey version2 (SF-12 v2)
SF-12 version 2 is a questionnaire that evaluates health-related quality of life (HRQoL). It consists of 12 items in 8 areas (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health).
Measured: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Patient Global Impression of Change (PGIC)
The PGIC is an index that assesses improvements in post-accident syndromes caused by traffic accident. Participants rate the improvement in post-accident syndromes after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse)
Measured: week 5, week 9, week 17
Economic evaluation question
In order to measure cost items, a questionnaire with questions measuring medical expenses, non-medical expenses, time costs, productivity loss costs, etc. is used.
Measured: Through study completion, an average of 4 months
Drug Consumption
Check the type and dose of drugs taken during the study period every visit
Measured: Through study completion, an average of 4 months
Adverse events
Check adverse events every visit
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start24 Jul 2021
- Primary completion30 Jun 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traffic AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, PhD, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494008
- Sponsor's protocol ID
- JS-CT-2021-09
- Status last verified
- Dec 2022
- First submitted
- 5 Aug 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Korean Herbal Medicine Treatment Strategy for Outpatients With Post-accident Syndromes After Acute Phase: A Pilot Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05494008
- Acronym / sponsor ID
- JS-CT-2021-09
- Conditions
- Traffic Accident, Whiplash Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single blind, randomized controlled trail. condition/disease: Post-accident syndromes after acute phase treatment/intervention: herbal medicine treatment strategy
Detailed description
The Korean herbal medicine is a 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. This treatment is known to relieve the post-accident syndromes and improve health. However, there are no studies examining the efficacy of Korean herbal medicine alone.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean herbal medicine treatment | Experimental | Procedure: Korean herbal medicine treatmentThe 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. |
| Non-Korean herbal medicine treatment | Active comparator | Procedure: Non-Korean herbal medicine treatmentThe control group received Korean medical treatment for twice a week for 4 weeks: acupuncture, pharmacoacupuncture, cupping and chuna. (except Korean herbal medicine) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 19-70 years on the date they sign the consent form
- 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
Key exclusion criteria (13 listed)
- Patients whose pain is not due to a traffic accident but due to an existing disease (hernia of intervertebral discs, spinal canal stenosis, fibromyalgia, etc.)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean herbal medicine treatmentKorean 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. | Procedure or surgery | Korean herbal medicine treatment |
| Non-Korean herbal medicine treatmentacupuncture, pharmacoacupuncture, cupping, chuna | Procedure or surgery | Non-Korean herbal medicine treatment |
Primary outcome
Numeric Rating Scale(NRS) of post-accident syndromes
Time frame: Change from baseline to 4 months
The severity of post-accident syndrome will be assessed using NRS. NRS is a scale in which the patient indicates their subjective severity of symptoms as a whole number from 0 to 10. The participant is asked to report their severity of post-accident syndrome using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
12 secondary outcomes
Numeric Rating Scale(NRS) of musculoskeletal complaints of post-accident syndromes
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of neurological complaints of post-accident syndromes
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of psychiatric complaints of post-accident syndromes
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of digestive systemic complaints of post-accident syndromes
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Numeric Rating Scale(NRS) of general symptoms of post-accident syndromes
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Impact of Event Scale-Revised-Korean (IES-R-K)
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
5-level EuroQol 5-dimension (EQ-5D-5L)
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Short-Form-12 Health Survey version2 (SF-12 v2)
Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Patient Global Impression of Change (PGIC)
Time frame: week 5, week 9, week 17
Economic evaluation question
Time frame: Through study completion, an average of 4 months
Drug Consumption
Time frame: Through study completion, an average of 4 months
Adverse events
Time frame: Through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Traffic Accident
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
Not yet recruitingObservational study
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial Fractures, Maxillofacial Injuries
Active, not recruiting
Transportation Safety in Adolescence
Automobile Accident
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, PhD principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Korean herbal medicine treatment and Non-Korean herbal medicine treatment in people with Traffic Accident and Whiplash Syndrome, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale(NRS) of post-accident syndromes (time frame: Change from baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.