Ginger Root Extract for Sciatic Pain Individuals (Ginger-NP)

December 28, 2025 updated by: Leslie Shen

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech University Health Sciences Center
        • Contact:
      • Lubbock, Texas, United States, 79430
        • Not yet recruiting
        • Texas Tech University Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Chwan-Li Shen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo group: 2,000 mg cellulose daily for 8 weeks
Dietary supplement: Placebo
Placebo (Sabinsa)
Active Comparator: Ginger
Ginger group: 2,000 mg ginger root extract daily for 8 weeks
Drug: Ginger
Ginger root extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma lipopolysaccharide binding protein (LBP)
Time Frame: baseline and after 8 weeks
Intestinal permeability biomarker
baseline and after 8 weeks
fecal zonulin
Time Frame: baseline and after 8 weeks
intestinal permeability marker
baseline and after 8 weeks
brief pain inventory (BPI)
Time Frame: baseline and after 8 weeks
pain assessment
baseline and after 8 weeks
SF-MPQ
Time Frame: baseline and after 8 weeks
pain assessment
baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fecal metabolites using LC-MS/MS analysis
Time Frame: baseline and after 8 weeks
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.
baseline and after 8 weeks
gut microbiome using 16S rRNA amplicon sequencing
Time Frame: baseline and after 8 weeks
Fecal gut microbiome composition is a collection of microorganisms that live in the human digestive tract.
baseline and after 8 weeks
neuroinflammation genes
Time Frame: baseline and after 8 weeks
Whole blood neuroinflammation gene profiles will be analyzed using nCounter® Neuroinflammation Panel to evaluate pathways, processes, and cell types that are involved in neuroinflammation.
baseline and after 8 weeks
structural connectivity using resting state-fMRI
Time Frame: baseline and after 8 weeks
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.
baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leslie Shen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ginger-sciatic pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available due to HIPAA regulation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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