Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06817018
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ginger Root Extract for Sciatic Pain Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713927', 'term': 'ginger extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma lipopolysaccharide binding protein (LBP)', 'timeFrame': 'baseline and after 8 weeks', 'description': 'Intestinal permeability biomarker'}, {'measure': 'fecal zonulin', 'timeFrame': 'baseline and after 8 weeks', 'description': 'intestinal permeability marker'}, {'measure': 'brief pain inventory (BPI)', 'timeFrame': 'baseline and after 8 weeks', 'description': 'pain assessment'}, {'measure': 'SF-MPQ', 'timeFrame': 'baseline and after 8 weeks', 'description': 'pain assessment'}], 'secondaryOutcomes': [{'measure': 'fecal metabolites using LC-MS/MS analysis', 'timeFrame': 'baseline and after 8 weeks', 'description': 'Untargeted fecal metabolites will be assessed using LC-MS/MS analysis and the combination of retention time and mass signature provides great specificity for each metabolite identification.'}, {'measure': 'gut microbiome using 16S rRNA amplicon sequencing', 'timeFrame': 'baseline and after 8 weeks', 'description': 'Fecal gut microbiome composition is a collection of microorganisms that live in the human digestive tract.'}, {'measure': 'neuroinflammation genes', 'timeFrame': 'baseline and after 8 weeks', 'description': 'Whole blood neuroinflammation gene profiles will be analyzed using nCounter® Neuroinflammation Panel to evaluate pathways, processes, and cell types that are involved in neuroinflammation.'}, {'measure': 'structural connectivity using resting state-fMRI', 'timeFrame': 'baseline and after 8 weeks', 'description': 'Resting state-fMRI connectivity in brain will be examined between the left and right amygdala seed regions and the broader bilateral mPFC, defined using the probabilistic Harvard-Oxford Subcortical Structural Atlas in FSL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuropathic Pain', 'Sciatic Pain']}, 'referencesModule': {'references': [{'pmid': '35047525', 'type': 'BACKGROUND', 'citation': 'Shen CL, Watkins BA, Kahathuduwa C, Chyu MC, Zabet-Moghaddam M, Elmassry MM, Luk HY, Brismee JM, Knox A, Lee J, Zumwalt M, Wang R, Wager TD, Neugebauer V. Tai Chi Improves Brain Functional Connectivity and Plasma Lysophosphatidylcholines in Postmenopausal Women With Knee Osteoarthritis: An Exploratory Pilot Study. Front Med (Lausanne). 2022 Jan 3;8:775344. doi: 10.3389/fmed.2021.775344. eCollection 2021.'}, {'pmid': '22861166', 'type': 'BACKGROUND', 'citation': 'Goncalves L, Dickenson AH. Asymmetric time-dependent activation of right central amygdala neurones in rats with peripheral neuropathy and pregabalin modulation. Eur J Neurosci. 2012 Nov;36(9):3204-13. doi: 10.1111/j.1460-9568.2012.08235.x. Epub 2012 Aug 3.'}, {'pmid': '28429339', 'type': 'BACKGROUND', 'citation': 'Checchia GA, Letizia Mauro G, Morico G, Oriente A, Lisi C, Polimeni V, Lucia M, Ranieri M; Management of Peripheral Neuropathies Study Group. Observational multicentric study on chronic sciatic pain: clinical data from 44 Italian centers. Eur Rev Med Pharmacol Sci. 2017 Apr;21(7):1653-1664.'}, {'pmid': '29369967', 'type': 'BACKGROUND', 'citation': 'Nation KM, De Felice M, Hernandez PI, Dodick DW, Neugebauer V, Navratilova E, Porreca F. Lateralized kappa opioid receptor signaling from the amygdala central nucleus promotes stress-induced functional pain. Pain. 2018 May;159(5):919-928. doi: 10.1097/j.pain.0000000000001167.'}, {'pmid': '32490042', 'type': 'BACKGROUND', 'citation': 'U Jumbo S, C MacDermid J, E Kalu M, L Packham T, S Athwal G, J Faber K. Measurement Properties of the Brief Pain Inventory-Short Form (BPI-SF) and the Revised Short McGill Pain Questionnaire-Version-2 (SF-MPQ-2) in Pain-related Musculoskeletal Conditions: A Systematic Review Protocol. Arch Bone Jt Surg. 2020 Mar;8(2):131-141. doi: 10.22038/abjs.2020.36779.1973.'}, {'pmid': '19356853', 'type': 'BACKGROUND', 'citation': 'Dworkin RH, Turk DC, Revicki DA, Harding G, Coyne KS, Peirce-Sandner S, Bhagwat D, Everton D, Burke LB, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA, Melzack R. Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain. 2009 Jul;144(1-2):35-42. doi: 10.1016/j.pain.2009.02.007. Epub 2009 Apr 7.'}, {'pmid': '34748918', 'type': 'BACKGROUND', 'citation': 'Shen CL, Wang R, Ji G, Elmassry MM, Zabet-Moghaddam M, Vellers H, Hamood AN, Gong X, Mirzaei P, Sang S, Neugebauer V. Dietary supplementation of gingerols- and shogaols-enriched ginger root extract attenuate pain-associated behaviors while modulating gut microbiota and metabolites in rats with spinal nerve ligation. J Nutr Biochem. 2022 Feb;100:108904. doi: 10.1016/j.jnutbio.2021.108904. Epub 2021 Nov 6.'}, {'pmid': '35873544', 'type': 'BACKGROUND', 'citation': 'Shen CL, Wang R, Yakhnitsa V, Santos JM, Watson C, Kiritoshi T, Ji G, Hamood AN, Neugebauer V. Gingerol-Enriched Ginger Supplementation Mitigates Neuropathic Pain via Mitigating Intestinal Permeability and Neuroinflammation: Gut-Brain Connection. Front Pharmacol. 2022 Jul 8;13:912609. doi: 10.3389/fphar.2022.912609. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Neuropathic pain affects the quality of life of many Americans. Non-pharmacological strategies such as bioactive compounds in foods are being explored as therapeutics but can also serve as tools to better understand pain mechanisms. The previous study reported that ginger root extract supplementation palliated pain-spectrum behaviors in animals with neuropathic pain via the microbiota-gut-brain axis. The proposed study is primarily designed to use ginger supplementation for a better understanding of the role of microbiota-gut-brain interactions in sciatica states in a randomized, double-blinded, and placebo-controlled trial. Eighty participants with sciatica will be randomized to receive placebo (2000 mg starch daily) or ginger (2000 mg daily) for 8 weeks. This study will evaluate the effects of ginger supplementation on gut function measured as gut microbiota composition using 16S rRNA sequencing analysis, intestinal permeability based on plasma lipopolysaccharide binding protein and fecal zonulin using ELISA, and fecal metabolites using LC-MS/MS analysis (SA 1); on neuroinflammation in whole blood mRNA using nCounter® Neuroinflammation Panels analysis (SA 2); and on pain-associated outcomes and brain neuroplasticity by assessing functional (resting state-fMRI) and structural (Diffusion Tensor Imaging) connectivity (SA 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 18-85 years old men and women with BMI \\< 25 or ≥ 30 kg/m2\n* low back or gluteal pain radiating into leg(s) past the knee (sciatica) with pain duration of at least 3 months (chronic sciatica)\n* pain scale \\> 3 out of 10 (0=no pain,10=worst pain imaginable) during the past 24 hours\n* willingness to accept randomization.\n* woman of childbearing potential agrees to use an effective form of contraception during the study\n\nExclusion criteria:\n\nSciatica aspects:\n\n* known or suspected serious spinal pathology (e.g., cauda equina syndrome or spinal fracture)\n* scheduled, or being considered, for spinal surgery or interventional procedures for sciatica during study period\n* focal neurological deficits with progressive or disabling symptoms\n* low back pain without sciatica\n\nGI aspects:\n\n* unstable GI disorder\n* history of chronic or systemic autoimmune diseases with GI involvement\n* recent (\\<1 month) appearance of diarrhea or hematochezia before study begins\n* recent (\\<1 month) exposure to antibiotics before study start\n\nOther exclusion considerations:\n\n* pregnant or breast-feeding women\n* women of child-bearing potential will have a urine pregnancy test done prior to the baseline MRI and administration of any study drug. The clinical research coordinator will run the pregnancy test and inform the patient of the results. If the test is positive, they will be withdrawn from study participation.\n* cognitive impairment, history of psychiatric conditions indicating mental health instability or incapacity\n* likeliness of moving during the trial, lack of transportation, or unavailability at sample collection times.\n* presence of a bleeding diathesis\n* taking anticoagulant medications (e.g Heparin, Warfarin)\n* taking dual antiplatelet medications (e.g. aspirin + Plavix)\n* participants with clinically significant laboratory abnormalities of liver function (AST and ALT) and kidney function (BUN and serum creatinine) abnormalities. Definition of clinically significant for liver function is AST/ALT ≥ 3.0x ULN and for kidney function is serum creatinine \\> 2.0 mg/dl and BUN \\> 1.5x ULN.'}, 'identificationModule': {'nctId': 'NCT06817018', 'acronym': 'Ginger-NP', 'briefTitle': 'Ginger Root Extract for Sciatic Pain Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center'}, 'officialTitle': 'Ginger and the Microbiota-gut-brain Connection in Sciatic Pain Individuals', 'orgStudyIdInfo': {'id': 'Ginger-sciatic pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo group: 2,000 mg cellulose daily for 8 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ginger', 'description': 'Ginger group: 2,000 mg ginger root extract daily for 8 weeks', 'interventionNames': ['Drug: Ginger']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (Sabinsa)', 'armGroupLabels': ['Placebo']}, {'name': 'Ginger', 'type': 'DRUG', 'description': 'Ginger root extract', 'armGroupLabels': ['Ginger']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chwan-Li (Leslie) Shen, PhD', 'role': 'CONTACT', 'email': 'leslie.shen@ttuhsc.edu', 'phone': '806-743-2815'}, {'name': 'Chwan-Li Shen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chwan-Li (Leslie) Shen, PhD, CCRP', 'role': 'CONTACT', 'email': 'leslie.shen@ttuhsc.edu', 'phone': '8067432815'}], 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'centralContacts': [{'name': 'Chwan-Li (Leslie) Shen, PhD', 'role': 'CONTACT', 'email': 'leslie.shen@ttuhsc.edu', 'phone': '806-743-2815'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available due to HIPAA regulation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leslie Shen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Pathology', 'investigatorFullName': 'Leslie Shen', 'investigatorAffiliation': 'Texas Tech University Health Sciences Center'}}}}