NCT06817018

Ginger Root Extract for Sciatic Pain Individuals

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Leslie Shen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Placebo (Sabinsa)
DRUG	Ginger	Ginger root extract

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-02-28
• Completion: 2028-02-28
• First posted: 2025-02-10
• Last updated: 2025-12-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study