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

NCT05494008 | Completed DMC

• 1 other identifier: JS-CT-2021-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Traffic Accident; Whiplash Syndrome

Outcome Measures

Primary Outcomes (1)

• 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'.

  Change from baseline to 4 months

Secondary Outcomes (12)

• Numeric Rating Scale(NRS) of musculoskeletal complaints of post-accident syndromes

  Baseline(week 1-1), week 3-1, week 5, week 9, week 17

• Numeric Rating Scale(NRS) of neurological complaints of post-accident syndromes

  Baseline(week 1-1), week 3-1, week 5, week 9, week 17

• Numeric Rating Scale(NRS) of psychiatric complaints of post-accident syndromes

  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

  Baseline(week 1-1), week 3-1, week 5, week 9, week 17

• Numeric Rating Scale(NRS) of general symptoms of post-accident syndromes

  Baseline(week 1-1), week 3-1, week 5, week 9, week 17

Study Arms (2)

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.

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)

Procedure: Non-Korean herbal medicine treatment

Interventions

Korean herbal medicine treatment PROCEDURE

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.

Korean herbal medicine treatment

Non-Korean herbal medicine treatment PROCEDURE

acupuncture, pharmacoacupuncture, cupping, chuna

Non-Korean herbal medicine treatment

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Study Officials

• In-Hyuk Ha, PhD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: July 24, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 13, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)