Clinical trial NCT05494008: 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
Overall status: COMPLETED
Phase: NA
Conditions: Traffic Accident
Whiplash Syndrome
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Numeric Rating Scale(NRS) of post-accident syndromes
timeFrame: Change from baseline to 4 months
Secondary outcomes:
measure: Numeric Rating Scale(NRS) of musculoskeletal complaints of post-accident syndromes
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: Numeric Rating Scale(NRS) of neurological complaints of post-accident syndromes
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: Numeric Rating Scale(NRS) of psychiatric complaints of post-accident syndromes
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: Numeric Rating Scale(NRS) of digestive systemic complaints of post-accident syndromes
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: Numeric Rating Scale(NRS) of general symptoms of post-accident syndromes
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: Impact of Event Scale-Revised-Korean (IES-R-K)
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: 5-level EuroQol 5-dimension (EQ-5D-5L)
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: Short-Form-12 Health Survey version2 (SF-12 v2)
timeFrame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17
measure: Patient Global Impression of Change (PGIC)
timeFrame: week 5, week 9, week 17
measure: Economic evaluation question
timeFrame: Through study completion, an average of 4 months
measure: Drug Consumption
timeFrame: Through study completion, an average of 4 months
measure: Adverse events
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, PhD
role: PRINCIPAL_INVESTIGATOR
References: