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Neuropathic PainPhase 2Ginger-NPNCT06817018

Ginger Root Extract for Sciatic Pain Individuals

A Phase 2 study testing Ginger in people with Neuropathic Pain and Sciatic Pain, run by Leslie Shen at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Neuropathic Pain, Sciatic Pain
What is being tested?
Ginger
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesUnited States
Study dates
1 Jul 2025to 28 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-85 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

Who cannot join

  • 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:
Show all 19Show fewer
  • 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
  • Other exclusion considerations:
  • 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
  • taking anticoagulant medications (e.g Heparin, Warfarin)
  • taking dual antiplatelet medications (e.g. aspirin + Plavix)
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chwan-Li (Leslie) Shen, PhD contact

806-743-2815

leslie.shen@ttuhsc.edu

United States2 sites, 2 recruiting

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

    Chwan-Li (Leslie) Shen, PhD, 806-743-2815, leslie.shen@ttuhsc.edu

    Chwan-Li Shen, PhD

    Not yet recruiting

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

    Chwan-Li (Leslie) Shen, PhD, CCRP, 8067432815, leslie.shen@ttuhsc.edu

    Recruiting

Other trials in United States

About this study

Official title: Ginger and the Microbiota-gut-brain Connection in Sciatic Pain Individuals

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).

Being tested
Placebo, Ginger
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Placebo (Sabinsa)

  • GingerDrug

    Ginger root extract

Study groups in NCT06817018
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo group: 2,000 mg cellulose daily for 8 weeks
Receives: Dietary Supplement: Placebo
GingerActive comparatorGinger group: 2,000 mg ginger root extract daily for 8 weeks
Receives: Drug: Ginger

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. plasma lipopolysaccharide binding protein (LBP)

    Intestinal permeability biomarker

    Measured: baseline and after 8 weeks

  2. fecal zonulin

    intestinal permeability marker

    Measured: baseline and after 8 weeks

  3. brief pain inventory (BPI)

    pain assessment

    Measured: baseline and after 8 weeks

  4. SF-MPQ

    pain assessment

    Measured: baseline and after 8 weeks

Secondary outcomes (4)

  1. fecal metabolites using LC-MS/MS analysis

    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.

    Measured: baseline and after 8 weeks

  2. gut microbiome using 16S rRNA amplicon sequencing

    Fecal gut microbiome composition is a collection of microorganisms that live in the human digestive tract.

    Measured: baseline and after 8 weeks

  3. neuroinflammation genes

    Whole blood neuroinflammation gene profiles will be analyzed using nCounter® Neuroinflammation Panel to evaluate pathways, processes, and cell types that are involved in neuroinflammation.

    Measured: baseline and after 8 weeks

  4. structural connectivity using resting state-fMRI

    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.

    Measured: baseline and after 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start1 Jul 2025
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06817018
Sponsor's protocol ID
Ginger-sciatic pain
Acronym
Ginger-NP
Status last verified
Dec 2025
First submitted
3 Feb 2025
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available due to HIPAA regulation.

Publications

  • 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.

    PubMed 35047525

  • 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.

    PubMed 22861166

  • 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.

    PubMed 28429339

  • 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.

    PubMed 29369967

  • 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.

    PubMed 32490042

  • 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.

    PubMed 19356853

  • 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.

    PubMed 34748918

  • 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.

    PubMed 35873544

  • 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 Jun;73:103117. doi: 10.1016/j.clnesp.2026.103117. Epub 2026 Mar 12.

    PubMed 41831719

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ginger in people with Neuropathic Pain and Sciatic Pain, run by Leslie Shen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chwan-Li (Leslie) Shen, PhD (806-743-2815, leslie.shen@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

plasma lipopolysaccharide binding protein (LBP) (time frame: baseline and after 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06817018, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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