Clinical trial to evaluate the efficacy and safety of Ojucksan on patients with non-specific chronic low back pain

A 4-week, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of Ojuksan on patients with non-specific chronic low back pain

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003972

Enrollment

Registered

2019-05-22

Start date

2019-10-31

Completion date

Unknown

Last updated

2019-06-17

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

Conditions

None listed

Interventions

Drug : Participants who met the inclusion criteria are randomised to experimental group(Ojuksan group) or control group(placebo group). -Experimental group: Ojuksan, 3 times/day(total 15g),(3g/1 times

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aults aged 18 to 75 years 2. Patients with back pain for more than 3 months 3. Person corresponding to class 1~4 of Quebec Task Force System 4. Person with more than VAS(Visual analogue scale) 40mm 5. Person who have no problem with language, expression, concentration 6. Those who have heard the full explanation of this human application test, fully understand it, and have voluntarily decided to participate and have agreed in writing to comply with the precautions.

Exclusion criteria

Exclusion criteria: 1. A person who received intraspinal steroid injecion in A within 3months 2. Those who have difficulty in posture(standing posture, lumbar flexion, extension) for examination due to severe back pain 3. People who need surgery because of neurological symptoms(cauda equina syndrome, sensoparalysis, motor paralysis) 4. A persion with past history of spinal opersion(plate fixation, spondylodesis) 5. A persion with a neurodegenerative disease(Neuromuscular scoliosis) 6. Those with a history of severe trauma, rheumatoid arthritis(RA), autoimmune dieases 7. Those with a past history of vertebral fracture, Inflammatory spondylitis, spinal infection, metastatic cancer 8. Those who have had experience in antipsychotic medication within three months prior to screening. 9. Someone who has or is suspected of drug or alchol abuse. 10. A pregnant or breast-feeding woman 11. Diagnostic test A person who is determined by the Principal inspector to be ineligible for research due to medical examination results or other reasons

Design outcomes

Primary

Measure	Time frame
Visual analogue scale(VAS)	—

Secondary

Measure	Time frame
Oswestry Low Back Pain Disability Questionnaire(ODI);Roland0Morris Disability Questionnaire(RMDQ);SF(Short-Foam)-36 health survey;Adverse events;laboratory test value;Vital sign;EKG(Electrocardiogram)	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Kwon

Wonkwang University, Gwangju Medical Center

exeterin@naver.com+82-62-670-6452

Outcome results