Actively Recruiting
Ginger Root Extract for Sciatic Pain Individuals
Led by Leslie Shen · Updated on 2025-12-30
80
Participants Needed
2
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ginger Root Extract for Sciatic Pain Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 85 years with BMI less than 25 or 30 and above kg/m2
- Chronic low back or gluteal pain radiating into the leg(s) past the knee lasting at least 3 months
- Pain score greater than 3 out of 10 during the past 24 hours
- Willingness to accept randomization
- Women of childbearing potential agree to use effective contraception during the study
You will not qualify if you...
- Known or suspected serious spinal problems such as cauda equina syndrome or spinal fracture
- Scheduled or considering spinal surgery or procedures for sciatica during the study period
- Progressive or disabling neurological symptoms
- Low back pain without sciatica
- Unstable gastrointestinal disorders
- History of chronic or systemic autoimmune diseases with gastrointestinal involvement
- Recent diarrhea or blood in stool within 1 month before study start
- Recent antibiotic use within 1 month before study start
- Pregnant or breastfeeding women
- Positive pregnancy test before baseline MRI or study drug administration
- Cognitive impairment or psychiatric conditions indicating mental instability
- Likely to move away, lack of transportation, or unavailable for sample collection
- Bleeding disorders
- Taking anticoagulant or dual antiplatelet medications
- Significant liver function abnormalities (AST/ALT ≥ 3 times upper limit)
- Significant kidney function abnormalities (serum creatinine > 2.0 mg/dl or BUN > 1.5 times upper limit)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Not Yet Recruiting
2
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Actively Recruiting
Research Team
C
Chwan-Li (Leslie) Shen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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