Ginger for Nerve Pain

(Ginger-NP Trial)

Overseen By Chwan-Li (Leslie) Shen, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Leslie Shen

Must not be taking: Anticoagulants

Disqualifiers: Serious spinal pathology, Chronic GI disorder, Autoimmune diseases, Psychiatric conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medication that affects blood clotting or platelet function.

What data supports the effectiveness of the treatment Ginger Root Extract for nerve pain?

Research shows that ginger, including its components like gingerol, can reduce pain and inflammation in various conditions, such as neuropathic pain in animal studies and pain from conditions like osteoarthritis and migraines in humans. This suggests that ginger root extract might help with nerve pain by reducing inflammation and pain sensitivity. ^{1 2 3 4 5}

Is ginger safe for use in humans?

Ginger is generally considered a safe herbal medicine with only a few minor side effects reported. However, more studies are needed to understand its long-term safety in humans. ^{1 6 7 8 9}

How does ginger root extract differ from other treatments for nerve pain?

Ginger root extract is unique in its ability to reduce nerve pain by modulating gut microbiota and reducing neuroinflammation, which is different from many standard pain medications that primarily target pain pathways directly. Additionally, ginger contains compounds like gingerols and shogaols that have anti-inflammatory properties and can be administered orally, making it a promising natural alternative for managing neuropathic pain. ^{1 2 3 4 5}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 2000 mg of ginger root extract or placebo daily for 8 weeks

8 weeks

Baseline and after 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ginger Root Extract

Trial Overview 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.

Participant Groups

Group I: Ginger Active Control 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Leslie Shen

Lead Sponsor

Trials

1

Recruited

80+

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Antihyperalgesia potency of Zingiber officinale var. Rubrum in inflammatory and neuropathy-induced chronic pain condition in mice. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Clinical trials on pain lowering effect of ginger: A narrative review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Gingerol-Enriched Ginger Supplementation Mitigates Neuropathic Pain via Mitigating Intestinal Permeability and Neuroinflammation: Gut-Brain Connection. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intrathecal [6]-gingerol administration alleviates peripherally induced neuropathic pain in male Sprague-Dawley rats. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Dietary supplementation of gingerols- and shogaols-enriched ginger root extract attenuate pain-associated behaviors while modulating gut microbiota and metabolites in rats with spinal nerve ligation. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A Randomized Double-Blind Trial of Ginger Root for Reducing Muscle Soreness and Improving Physical Performance Recovery Among Experienced Recreational Distance Runners. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, cross-over study of ginger extracts and ibuprofen in osteoarthritis. [2023]

8. Greece pubmed.ncbi.nlm.nih.gov

Effects of ginger and its pungent constituents on transient receptor potential channels. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): a review of recent research. [2023]