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Evaluation of Effectiveness and Safety of Korean Herbal Medicine for Post-accident Syndromes After Acute Phase

Primary Purpose

Traffic Accident, Whiplash Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korean herbal medicine treatment
Non-Korean herbal medicine treatment
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traffic Accident

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Korean herbal medicine treatment

Non-Korean herbal medicine treatment

Arm Description

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.

The control group received Korean medical treatment for twice a week for 4 weeks: acupuncture, pharmacoacupuncture, cupping and chuna. (except Korean herbal medicine)

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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'.
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'.
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'.
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'.
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'.
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.
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.
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).
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)
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.
Drug Consumption
Check the type and dose of drugs taken during the study period every visit
Adverse events
Check adverse events every visit

Full Information

First Posted
August 5, 2022
Last Updated
December 19, 2022
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05494008
Brief Title
Evaluation of Effectiveness and Safety of Korean Herbal Medicine for Post-accident Syndromes After Acute Phase
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 24, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traffic Accident, Whiplash Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Korean herbal medicine treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Korean herbal medicine treatment
Arm Type
Active Comparator
Arm Description
The control group received Korean medical treatment for twice a week for 4 weeks: acupuncture, pharmacoacupuncture, cupping and chuna. (except Korean herbal medicine)
Intervention Type
Procedure
Intervention Name(s)
Korean herbal medicine treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-Korean herbal medicine treatment
Intervention Description
acupuncture, pharmacoacupuncture, cupping, chuna
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of post-accident syndromes
Description
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'.
Time Frame
Change from baseline to 4 months
Secondary Outcome Measure Information:
Title
Numeric Rating Scale(NRS) of musculoskeletal complaints of post-accident syndromes
Description
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'.
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
Numeric Rating Scale(NRS) of neurological complaints of post-accident syndromes
Description
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'.
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
Numeric Rating Scale(NRS) of psychiatric complaints of post-accident syndromes
Description
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'.
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
Numeric Rating Scale(NRS) of digestive systemic complaints of post-accident syndromes
Description
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'.
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
Numeric Rating Scale(NRS) of general symptoms of post-accident syndromes
Description
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'.
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
Impact of Event Scale-Revised-Korean (IES-R-K)
Description
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.
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
5-level EuroQol 5-dimension (EQ-5D-5L)
Description
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.
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
Short-Form-12 Health Survey version2 (SF-12 v2)
Description
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).
Time Frame
Baseline(week 1-1), week 3-1, week 5, week 9, week 17
Title
Patient Global Impression of Change (PGIC)
Description
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)
Time Frame
week 5, week 9, week 17
Title
Economic evaluation question
Description
In order to measure cost items, a questionnaire with questions measuring medical expenses, non-medical expenses, time costs, productivity loss costs, etc. is used.
Time Frame
Through study completion, an average of 4 months
Title
Drug Consumption
Description
Check the type and dose of drugs taken during the study period every visit
Time Frame
Through study completion, an average of 4 months
Title
Adverse events
Description
Check adverse events every visit
Time Frame
Through study completion, an average of 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, PhD
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Effectiveness and Safety of Korean Herbal Medicine for Post-accident Syndromes After Acute Phase

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