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

Jaseng Medical Foundation

Status: Completed

Conditions: Whiplash Syndrome; Traffic Accident

Treatments: Procedure: Non-Korean herbal medicine treatment; Procedure: Korean herbal medicine treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05494008

JS-CT-2021-09

Details and patient eligibility

About

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

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Korean herbal medicine treatment

Experimental group

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.

Treatment:

Procedure: Korean herbal medicine treatment

Non-Korean herbal medicine treatment

Active Comparator group

Description:

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

Treatment:

Procedure: Non-Korean herbal medicine treatment