Ginger Root Extract for Sciatic Pain Individuals

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Neuropathic Pain, Sciatic Pain

In brief

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 facts

Study ID: NCT06817018
Run by: Leslie Shen
People needed: 80
Starts: 2025-07-01
Expected to finish: 2028-02-28
Last updated by the study team: 2025-12-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

18-85 years old men and women with BMI < 25 or ≥ 30 kg/m2
low back or gluteal pain radiating into leg(s) past the knee (sciatica) with pain duration of at least 3 months (chronic sciatica)
pain scale > 3 out of 10 (0=no pain,10=worst pain imaginable) during the past 24 hours
willingness to accept randomization.
woman of childbearing potential agrees to use an effective form of contraception during the study

You may not qualify if…

Sciatica aspects:
known or suspected serious spinal pathology (e.g., cauda equina syndrome or spinal fracture)
scheduled, or being considered, for spinal surgery or interventional procedures for sciatica during study period
focal neurological deficits with progressive or disabling symptoms
low back pain without sciatica
GI aspects:
unstable GI disorder
history of chronic or systemic autoimmune diseases with GI involvement
recent (<1 month) appearance of diarrhea or hematochezia before study begins
recent (<1 month) exposure to antibiotics before study start
Other exclusion considerations:
pregnant or breast-feeding women
women of child-bearing potential will have a urine pregnancy test done prior to the baseline MRI and administration of any study drug. The clinical research coordinator will run the pregnancy test and inform the patient of the results. If the test is positive, they will be withdrawn from study participation.
cognitive impairment, history of psychiatric conditions indicating mental health instability or incapacity
likeliness of moving during the trial, lack of transportation, or unavailability at sample collection times.
presence of a bleeding diathesis
taking anticoagulant medications (e.g Heparin, Warfarin)
taking dual antiplatelet medications (e.g. aspirin + Plavix)
participants with clinically significant laboratory abnormalities of liver function (AST and ALT) and kidney function (BUN and serum creatinine) abnormalities. Definition of clinically significant for liver function is AST/ALT ≥ 3.0x ULN and for kidney function is serum creatinine > 2.0 mg/dl and BUN > 1.5x ULN.

Where it is running

Texas Tech University Health Sciences Center — Lubbock, Texas, United States (enrolling)
Texas Tech University Health Sciences Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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