Ginger Root Extract for Sciatic Pain Individuals

Phase 2

Recruiting

• Conditions: Neuropathic Pain; Sciatic 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

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-10
• Study Start: 2025-07-01
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-22
• Last Update Posted: 2025-10-24
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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