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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004647

Enrollment

Registered

2020-01-23

Start date

2020-01-03

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The clinical trial drug (IP) for this clinical trial is 200 mg of Joins oral agent. Take three times a day and one tablets at a time (200 mg x 3 times) for 12 weeks. The control group drug plac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
VAS variation of back pain or limb radiation at 12th week post-treatment time compared to pre-treatment.	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactMin Ah Lee

Yonsei University Health System, Severance Hospital

Outcome results