Ginger Root Extract for Sciatic Pain Individuals

NCT06817018 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Ginger-sciatic pain
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Neuropathic Pain; Sciatic Pain

Outcome Measures

Primary Outcomes (4)

• plasma lipopolysaccharide binding protein (LBP)

  Intestinal permeability biomarker

  baseline and after 8 weeks

• fecal zonulin

  intestinal permeability marker

  baseline and after 8 weeks

• brief pain inventory (BPI)

  pain assessment

  baseline and after 8 weeks

• SF-MPQ

  pain assessment

  baseline and after 8 weeks

Secondary Outcomes (4)

• fecal metabolites using LC-MS/MS analysis

  baseline and after 8 weeks

• gut microbiome using 16S rRNA amplicon sequencing

  baseline and after 8 weeks

• neuroinflammation genes

  baseline and after 8 weeks

• structural connectivity using resting state-fMRI

  baseline and after 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo group: 2,000 mg cellulose daily for 8 weeks

Dietary Supplement: Placebo

Ginger

ACTIVE COMPARATOR

Ginger group: 2,000 mg ginger root extract daily for 8 weeks

Drug: Ginger

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo (Sabinsa)

Placebo

Ginger DRUG

Ginger root extract

Ginger

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old men and women with BMI \< 25 or ≥ 30 kg/m2
• low back or gluteal pain radiating into leg(s) past the knee (sciatica) with pain duration of at least 3 months (chronic sciatica)
• pain scale \> 3 out of 10 (0=no pain,10=worst pain imaginable) during the past 24 hours
• willingness to accept randomization.
• woman of childbearing potential agrees to use an effective form of contraception during the study

You may not qualify if:

• Sciatica aspects:
• known or suspected serious spinal pathology (e.g., cauda equina syndrome or spinal fracture)
• scheduled, or being considered, for spinal surgery or interventional procedures for sciatica during study period
• focal neurological deficits with progressive or disabling symptoms
• low back pain without sciatica
• GI aspects:
• unstable GI disorder
• history of chronic or systemic autoimmune diseases with GI involvement
• recent (\<1 month) appearance of diarrhea or hematochezia before study begins
• recent (\<1 month) exposure to antibiotics before study start
• pregnant or breast-feeding women
• 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.
• cognitive impairment, history of psychiatric conditions indicating mental health instability or incapacity
• likeliness of moving during the trial, lack of transportation, or unavailability at sample collection times.
• presence of a bleeding diathesis

Sponsors & Collaborators

• Leslie Shen: lead

Study Sites (2)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

NOT YET RECRUITING

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

RECRUITING

Related Publications (9)

• 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: 35047525 BACKGROUND

• 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: 22861166 BACKGROUND

• 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: 28429339 BACKGROUND

• 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: 29369967 BACKGROUND

• 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: 32490042 BACKGROUND

• 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: 19356853 BACKGROUND

• 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: 34748918 BACKGROUND

• 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.

  PMID: 35873544 BACKGROUND

• Shen CL, Elmassry MM, Kahathuduwa C, Lee J, Day MR, Edwards DS, Parmar H, Wager TD, Liu X, Baccus M, Hamood A, Neugebauer V. Influence of Ginger Root Extract Supplementation on the Microbiota-Gut-Brain Axis in Individuals with Sciatica: Study Protocol for a Double-Blind, Placebo-Controlled Randomized Trial. Clin Nutr ESPEN. 2026 Mar 12:103117. doi: 10.1016/j.clnesp.2026.103117. Online ahead of print.

  PMID: 41831719 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chwan-Li (Leslie) Shen, PhD

CONTACT

806-743-2815; leslie.shen@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pathology

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)