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

Not Applicable

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0003972
• Lead Sponsor: Wonkwang University, Gwangju Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale(VAS)

Secondary Outcome Measures

Name	Time	Method
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)