Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain

NCT ID: NCT02988232

Last Updated: 2021-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2020-12-30

Brief Summary

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The Purpose of this trial is to investigate the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain

Detailed Description

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Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work-related Chronic Low Back Pain

Conditions

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Low Back Pain Workplace

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment(SGHH)

Admission to Sogyeonghwalhyeol-tang granule

Group Type EXPERIMENTAL

Sogyeonghwalhyeol-tang

Intervention Type DRUG

herbal extract

Placebo

admission to placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

extract powder with same appearance, odor and color as SGHH

Interventions

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Placebo

extract powder with same appearance, odor and color as SGHH

Intervention Type DRUG

Sogyeonghwalhyeol-tang

herbal extract

Intervention Type DRUG

Other Intervention Names

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SGHH

Eligibility Criteria

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Inclusion Criteria

* Inpatients with chief complaint of low back pain in oriental rehabilitation medical center
* Age 19 - 65
* Workplace Vulnerable populations(hospital workers, office worker, blue collar workers, transit workers)
* Patients must include all of the following symptoms:

* Those who have 4 \~7 cm of VAS pain score;
* Those who has classified as 'at risk non-complier' or 'pain complaints' by KOSHA questionnaire
* Ability to have normal communication
* Ability to give informed consent

Exclusion Criteria

1. Patients with pain duration of 3 months or less
2. Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test
3. Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc)
4. Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level)
5. Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
6. Patients with history of spinal surgery
7. Patients with more severe pain than pain caused by low back pain
8. Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc.
9. Patients with history of Medical Malpractice Case
10. Patients with treatment history of low back pain within 1 month either KM or WM
11. Patients participating in other clinical studies within 3 months
12. Pregnant patients or patients with plans of pregnancy or lactating patients
13. Patients disagree to sign the informed consent form
14. Patients deemed unsuitable for participating the trial by the researchers
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sangji University Oriental Medical Center, Korea

UNKNOWN

Sponsor Role collaborator

Semyung University Korean Medicine Hospital in Chungju, Korea

UNKNOWN

Sponsor Role collaborator

Daejeon University

OTHER

Sponsor Role collaborator

Gachon University Gil Oriental Medical Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yun-Kyung Song

KMD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun-Kyung Song, PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon University of Oriental Hospital

Locations

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Gachon University Gil Oriental Medical Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ISEE_2015_WRMD

Identifier Type: -

Identifier Source: org_study_id

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