None listed
Conditions
Interventions
Drug : For 6 weeks, participants will take one sachet of Sokyung-Hwalhyul-Tang granules or placebo three times daily, before or between meals.
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 19 to under 65 years. 2. Low back pain persisting for more than 3 months, with low back pain as the primary complaint. 3. Pain and bothersomeness scored 4 or higher on a 10 cm Visual Analogue Scale (VAS) within the week prior to the study. 4. Voluntary participation after receiving a detailed explanation of the clinical trial and providing written informed consent to adhere to the precautions.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or history of hypersensitivity to the herbal components of Sokyung-Hwalhyeol-Tang or other traditional herbal medicines. 2. Abnormalities observed during lower extremity neurological examinations. 3. Severe neurological symptoms, such as cauda equina syndrome or sensory and motor paralysis, requiring surgical intervention. 4. History of spinal surgery or scheduled surgery during the clinical trial period. 5. Diagnosis of neuromuscular scoliosis or neurodegenerative disorders. 6. Low back pain potentially attributable to specific medical conditions, such as vertebral fractures, inflammatory spondylitis, spinal infections, or malignancies. 7. Pregnant or lactating women, those planning pregnancy, or individuals of childbearing potential not agreeing to use appropriate contraceptive methods. 8. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, as the study intervention contains lactose. 9. Hepatic or renal impairment (AST or ALT > 2 times the upper limit of normal, serum creatinine > 2.0 mg/dL). 10. History of cardiac disorders, uncontrolled hypertension (systolic = 160 mmHg or diastolic = 100 mmHg), or classified as high-risk for hypertension. 11. Weak gastrointestinal constitution or a tendency for diarrhea. 12. Recent acupuncture, pharmacological treatments, injections, physical therapy, or manual therapy related to low back pain within the past two weeks. 13. Pain in other regions more severe than in the lumbar area. 14. Participation in another clinical trial related to chronic low back pain within the past month. 15. Any other conditions deemed inappropriate for inclusion by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain score (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of trial participants whose VAS pain score decreased by at least 50%;Change in Roland and Morris Disability Questionnaire (RMDQ);Change in EuroQol-5D (EQ-5D) score;Patient Global Impression of Change (PGIC);Hematological and blood biochemical tests;Change in pain score (VAS);Proportion of trial participants whose VAS pain score decreased by at least the MCID (Minimal Clinically Important Difference; VAS 2) ;Proportion of trial participants whose VAS pain score decreased by at least 30% | — |
Countries
Korea, Republic of
Contacts
Public ContactYejin Hong
Kyung Hee University Hospital
Outcome results
None listed