Ginger Root Extract for Sciatic Pain Individuals

Phase 2

Not yet recruiting

• Conditions: Neuropathic Pain
• Interventions: Dietary Supplement: Placebo; Drug: Ginger

• Registration Number: NCT06817018
• Lead Sponsor: Leslie Shen

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-03-01
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 18-85 years old
• low back or gluteal pain radiating into leg(s) past the knee (sciatica) with pain duration of at least 3 months (chronic sciatica)
• visual analog 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:

• history of chronic GI disorder (i.e., irritable bowel syndrome, functional chronic constipation, coeliac diseases)
• 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 starts

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. 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 a medication that affects coagulation or platelet function
• unable or unwilling to have study MRIs done
• participants with clinically significant laboratory abnormities of liver function (AST and ALT) and kidney function (BUN and serum creatinine) abnormities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo group: 2,000 mg cellulose daily for 8 weeks
Ginger	Ginger	Ginger group: 2,000 mg ginger root extract daily for 8 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
fecal metabolites using LC-MS/MS analysis	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.
gut microbiome using 16S rRNA amplicon sequencing	baseline and after 8 weeks	Fecal gut microbiome composition is a collection of microorganisms that live in the human digestive tract.
neuroinflammation genes	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.
structural connectivity using resting state-fMRI	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.

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States