Ginger Root Extract for Sciatic Pain Individuals

Part of paid clinical trials in Lubbock, Texas.

Sponsor
Leslie Shen
Study ID
NCT06817018
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neuropathic Pain
  • Sciatic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DIETARY_SUPPLEMENT
    Placebo (Sabinsa)
  • Ginger — DRUG
    Ginger root extract

Study Details

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).

Key Dates

Start date
Jul 1, 2025
Status verified
Dec 2025
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo group: 2,000 mg cellulose daily for 8 weeks
  • Active Comparator: Ginger
    Ginger group: 2,000 mg ginger root extract daily for 8 weeks

Primary Outcome Measure

plasma lipopolysaccharide binding protein (LBP) [ Time Frame: baseline and after 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Texas Tech University Health Sciences CenterLubbockTexas79430
Chwan-Li (Leslie) Shen, PhD
[email protected]
806-743-2815
Chwan-Li Shen, PhD (PRINCIPAL_INVESTIGATOR)
Texas Tech University Health Sciences CenterLubbockTexas79430
Chwan-Li (Leslie) Shen, PhD, CCRP
[email protected]
8067432815

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By research site
Texas Tech University Health Sciences Center· Lubbock, TX

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