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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale(NRS) of post-accident syndromes
研究概览
简要总结
This study is a single blind, randomized controlled trail. condition/disease: Post-accident syndromes after acute phase treatment/intervention: herbal medicine treatment strategy
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Numeric Rating Scale(NRS) of post-accident syndromes
时间窗: Change from baseline to 4 months
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'.
次要结局
- Drug Consumption(Through study completion, an average of 4 months)
- 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 general symptoms of post-accident syndromes(Baseline(week 1-1), week 3-1, week 5, week 9, week 17)
- Impact of Event Scale-Revised-Korean (IES-R-K)(Baseline(week 1-1), week 3-1, week 5, week 9, week 17)
- 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 digestive systemic complaints of post-accident syndromes(Baseline(week 1-1), week 3-1, week 5, week 9, week 17)
- Economic evaluation question(Through study completion, an average of 4 months)
- 5-level EuroQol 5-dimension (EQ-5D-5L)(Baseline(week 1-1), week 3-1, week 5, week 9, week 17)
- Patient Global Impression of Change (PGIC)(week 5, week 9, week 17)
- Adverse events(Through study completion, an average of 4 months)
- Short-Form-12 Health Survey version2 (SF-12 v2)(Baseline(week 1-1), week 3-1, week 5, week 9, week 17)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation