Effectiveness of Joins® for Managing Lumbar Facetogenic Pain
NCT06204952 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2024-05-29
Summary
Obtain informed consent from patients with lumbar facet joint syndrome and, after enrollment, randomly assign them to Group A (Joins®) or Group B (Placebo). According to the allocation in each group, participants are instructed to take Joins® 200mg 1 tablet three times a day or placebo 1 tablet three times a day from day 1. Research subjects visit at 4-week intervals a total of 3 times (4 weeks, 8 weeks, 12 weeks) to collect various measurement variables. Both the test and control groups are observed during the period of taking the investigational medication without any changes or additional facet joint-related procedures (medial branch block, facet joint block). Acetaminophen is allowed as a rescue medication.
Conditions
- Facet Joint Syndrome
Interventions
- DRUG
-
Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract)
In patients with facet joint syndrome, Joins® (Clematidis Radix, Trichosanthes Root, Prunella Spike Extract) is administered at a dosage of 1 tablet three times a day for 12 weeks.
- DRUG
-
In patients with facet joint syndrome, placebo drug is administered at a dosage of 1 tablet three times a day for 12 weeks.
Sponsors & Collaborators
-
Jeeyoun Moon
lead OTHER
Principal Investigators
-
Jee Youn Moon, MD, PhD · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-22
- Primary Completion
- 2026-01-20
- Completion
- 2026-04-20
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