Ginger for Nerve Pain
(Ginger-NP Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Leslie Shen

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for individuals experiencing sciatic nerve pain. Participants must be diagnosed with sciatica to qualify. The study seeks to understand how ginger affects gut-brain interactions in relation to this condition.

Inclusion Criteria

I have had sciatica pain for at least 3 months.

Willingness to accept randomization

I agree to use birth control during the study.

+2 more

Exclusion Criteria

I am not pregnant if I can have children.

I have a bleeding disorder.

I cannot or do not want to undergo MRI scans for the study.

+13 more

Participant Groups

The study tests if ginger root extract can help manage sciatic pain compared to a placebo. It's a randomized, double-blind trial where participants will either receive ginger or a starch placebo daily for 8 weeks while their gut function and neuroinflammation are monitored.

2Treatment groups

Active Control

Placebo Group

Group I: GingerActive Control1 Intervention

Ginger group: 2,000 mg ginger root extract daily for 8 weeks

Group II: PlaceboPlacebo Group1 Intervention

Placebo group: 2,000 mg cellulose daily for 8 weeks