KCT0002998尚未招募未知
Efficacy, Safety, and Economic Evaluation of Adjuvant Herbal Medicine Treatment, Palmijihwang-hwan, for Chronic Low Back Pain: A Multicentered, Randomized, Assessor-blinded, Controlled Clinical Trial
Dongguk University Bundang Oriental Hospital0 个研究点目标入组 84 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1. Male and female subjects aged from 19 to 65
- •2. Low Back Pain which lasted more than 3 months is main chief complaint
- •3. Pain and discomfort due to low back pain is greater than 4 on the 10-cm visual analog scale (VAS) for one week before the enrollment
- •4. Participants who signed the agreed consent to follow instructions voluntarily after listening to the detailed explanation of this clinical trial
排除标准
- •1. Persons who have history of hypersensitive reactions of Palmijihwanghan's herb or herbal medicine.
- •2. Those who have abnormalities in the lower neurological examination
- •3. Those who have cauda equine syndrome or neurological symptoms of sensory or motor paralysis which need surgical treatments.
- •4. Those who have history of the spinal surgery or plans for surgery during the clinical trial period
- •5. Neuromuscular scoliosis or neurodegenerative disease
- •6. Those with diagnosed diseases which can be the possible cause of back pain: vertebral fracture, inflammatory spondylitis, spinal infection, malignant tumor, etc.
- •7. Female subects who are pregnant, or are brease-feeding or has plans for pregnancy plan, or does not consent to the choice of appropriate method of contraception.
- •8. Those who have a weak stomach or is prone to diarrhea
- •9. Person with genetic problems such as Galactose intolerance, Lappase lactase deficiency, or Glucose=galactose malabsorption.
- •10. Those who received acupuncture, medication, physical therapy, or manipulation therapy related to back pain within the last 2 weeks
- •11. Person with hepatotoxicity or nephrotoxicity(AST or ALT>2 x normal range, serum creatinine>2.0mg/dl)
- •12. Person with a history of heart disease, risk of hypertension or uncontrolled hypertension such as systolic blood pressure > 160mmHg or diastolic blood pressure < 100mmHg.
- •13. Those who have more severe pain in another area other than the low back area
- •14. Those who has participated in other clinical trials involving chronic low bac pain within the last month.
- •15. If clinical trial investigators judges that it is inappropriate for the subject to be enrolled for a fair reason
- •16. In case Korean medicine doctor in charge of testing is judged by diagnosis that the subject is not suitable for a Palmijihwanghan dose
研究者
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