The Pilot Study for the treatment effect and safety evaluation of Joins® for 12 weeks by comparing with Placebo in patients with chronic herniated lumbar intervertebral disc
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 64
1. Male and female patients aged between 19 and 80 years old with chronic herniated lumbar intervertebral disc
2. The patients whose back pain or leg radiation appeals to more than 4 points of VAS.
3. Persons diagnosed with chronic herniated lumbar intervertebral disc as a result of MRI conducted within 6 months of clinical findings and screening.
4. The patients who can clarify his or her clinical manifestation.
5. The patients who voluntarily agreed to participate in this clinical trial in writing.
1. The patients who is taking a relevant drug that may affect the determination of efficacy (e.g., anti-inflammatory drugs, myopia drugs), except that he or she can participate if he or she has a washingout period of more than two weeks.
2. The patients who administered various steroids by oral medicine or neurointervention within 12 weeks from the start date of clinical trials (visit 2)
3. The patients who have been given psychotropic medication and narcotic painkillers within four weeks from the start date of clinical trials (visit 2)
4. The patients with an overactive history of natural products (especially the Clematis mandshurica Maximowicz, Trichosanthes kirilowii Maximowicz, and Prunellae Spica).
5. The patients diagnosed with mental disorder and is taking medication.
6. The patients with known infection or cause of infection
7. The patients who developed herniated lumbar intervertebral disc due to trauma.
8. The patients who have participated in other clinical trials within four weeks before participating in this clinical trial (at the time of the screening).
9. The female patients who is nursing, pregnant, or likely to be pregnant.
10. The patients who have judged inadequate by the tester.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS variation of back pain or limb radiation at 12th week post-treatment time compared to pre-treatment.
- Secondary Outcome Measures
Name Time Method ODI implemented for each visit;VAS implemented for each visit;SF-36 implemented for each visit;change of MRI;number of use of relief drugs,;the characteristics and the incidence of adverse events