Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-04-16 @ 12:49 PM
Study NCT ID:
NCT02988232
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-09', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Numeric Rating Scale of Pain', 'timeFrame': 'Screening Visit, At baseline, week 2, 4, 6, 8', 'description': "A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain."}], 'secondaryOutcomes': [{'measure': "Change from Baseline in 'Roland Morris Disability Questionnaire'", 'timeFrame': 'Screening Visit, At baseline, week 2, 4, 6, 8', 'description': 'This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.'}, {'measure': 'Change from Baseline in European Quality of life 5 Dimension', 'timeFrame': 'Screening Visit, At baseline, week 2, 4, 6, 8', 'description': 'The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Work Related Chronic Low Back Pain', 'Korean Medicine', 'Sogyeonghwalhyeol-tang'], 'conditions': ['Low Back Pain', 'Workplace']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work-related Chronic Low Back Pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inpatients with chief complaint of low back pain in oriental rehabilitation medical center\n* Age 19 - 65\n* Workplace Vulnerable populations(hospital workers, office worker, blue collar workers, transit workers)\n* Patients must include all of the following symptoms:\n\n * Those who have 4 \\~7 cm of VAS pain score;\n * Those who has classified as 'at risk non-complier' or 'pain complaints' by KOSHA questionnaire\n* Ability to have normal communication\n* Ability to give informed consent\n\nExclusion Criteria:\n\n1. Patients with pain duration of 3 months or less\n2. Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test\n3. Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc)\n4. Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level)\n5. Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results\n6. Patients with history of spinal surgery\n7. Patients with more severe pain than pain caused by low back pain\n8. Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc.\n9. Patients with history of Medical Malpractice Case\n10. Patients with treatment history of low back pain within 1 month either KM or WM\n11. Patients participating in other clinical studies within 3 months\n12. Pregnant patients or patients with plans of pregnancy or lactating patients\n13. Patients disagree to sign the informed consent form\n14. Patients deemed unsuitable for participating the trial by the researchers"}, 'identificationModule': {'nctId': 'NCT02988232', 'acronym': 'WRMD', 'briefTitle': 'Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Oriental Medical Hospital'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain: a Multicenter, Randomized, Controlled, Clinical Trial', 'orgStudyIdInfo': {'id': 'ISEE_2015_WRMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment(SGHH)', 'description': 'Admission to Sogyeonghwalhyeol-tang granule', 'interventionNames': ['Drug: Sogyeonghwalhyeol-tang']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'admission to placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sogyeonghwalhyeol-tang', 'type': 'DRUG', 'otherNames': ['SGHH'], 'description': 'herbal extract', 'armGroupLabels': ['Treatment(SGHH)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'extract powder with same appearance, odor and color as SGHH', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Oriental Medical Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Yun-Kyung Song, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University of Oriental Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Oriental Medical Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sangji University Oriental Medical Center, Korea', 'class': 'UNKNOWN'}, {'name': 'Semyung University Korean Medicine Hospital in Chungju, Korea', 'class': 'UNKNOWN'}, {'name': 'Daejeon University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'KMD PhD', 'investigatorFullName': 'Yun-Kyung Song', 'investigatorAffiliation': 'Gachon University Gil Oriental Medical Hospital'}}}}