Ginger extract for sciatica
Ginger and the Microbiota-gut-brain Connection in Sciatic Pain Individuals
This trial will test whether taking 2000 mg of ginger daily for 8 weeks helps adults with chronic sciatica reduce pain and change gut-related markers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Locations | 2 sites (Lubbock, Texas and 1 other locations) |
| Trial ID | NCT06817018 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 2 trial will enroll 80 adults with chronic sciatica and randomize them to 2000 mg daily ginger extract or starch placebo for 8 weeks. Researchers will collect clinical pain measures alongside gut-focused biomarkers, including gut microbiota composition by 16S rRNA sequencing and markers of intestinal permeability such as lipopolysaccharide binding protein. The design builds on preclinical work suggesting ginger can modulate pain via the microbiota-gut-brain axis and seeks to translate those findings to people with sciatica. Safety, tolerability, and changes in both symptoms and gut biology will be compared between groups.
Who should consider this trial
Good fit: Adults aged 18–85 with chronic sciatica (leg pain past the knee for at least 3 months) who report pain >3/10 and are willing to be randomized are the intended participants.
Not a fit: People with non-sciatic low back pain, serious spinal pathology, planned spinal surgery or interventional procedures, unstable gastrointestinal disease, or recent severe GI symptoms are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, ginger supplementation could offer a low-risk, non-pharmacologic option to reduce sciatica pain and improve gut-related biomarkers.
How similar studies have performed: Preclinical animal studies reported that ginger reduced neuropathic pain via the microbiota-gut-brain axis, but clinical evidence in people with sciatica is limited and this approach remains novel in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 Exclusion criteria: 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 this trial is running
Lubbock, Texas and 1 other locations
- Texas Tech University Health Sciences Center — Lubbock, Texas, United States (Not_yet_recruiting)
- Texas Tech University Health Sciences Center — Lubbock, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Chwan-Li (Leslie) Shen, PhD
- Email: leslie.shen@ttuhsc.edu
- Phone: 806-743-2815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.