None listed
Conditions
Interventions
Drug : 1. [Palmijihwanghan+Acupuncture] A combined treatment group
(1) medicine(Palmijihwanghan) : Take one pill every six weeks, twice a day. Take an oral dose with water 30 minutes after breakfast a
Sponsors
Dongguk University Bundang Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain scores (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of pain scores (VAS);the clinical relevances (MCID, reduction ratio of 2 points or more on VAS compared to the 0 week (V1);the clinical relevances (MCID, reduction ratio of VAS 30% or more compared to the 0 week (V1);the clinical relevances (MCID, reduction ratio of VAS 50% or more compared to the 0 week (V1);Change of Roland and Morris Disability Questionnaire (RMDQ) scores;Change of EuroQol (EQ-5D) scores;Cost-benefit analysis and cost-effectiveness analysis between the two groups. | — |
Countries
Korea, Republic of
Contacts
Public ContactEunjung Kim
Dongguk University
Outcome results
None listed