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

Jaseng Medical Foundation40 enrolled

Overview

This study is a single blind, randomized controlled trail. condition/disease: Post-accident syndromes after acute phase treatment/intervention: herbal medicine treatment strategy

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Traffic Accident Whiplash Syndrome

Interventions

Korean herbal medicine treatmentPROCEDURE

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

acupuncture, pharmacoacupuncture, cupping, chuna

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

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'.

Time frame: Change from baseline to 4 months

Secondary Outcomes

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'.

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

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

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'.

Time frame: Baseline(week 1-1), week 3-1, week 5, week 9, week 17

Data from ClinicalTrials.gov

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