Ginger extract for sciatica

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 If the test is positive, they will be withdrawn from study participation.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 it's running

• Texas Tech University Health Sciences Center
  Lubbock, Texas, United States Recruiting
• Texas Tech University Health Sciences Center
  Lubbock, Texas, United States Not yet recruiting

Study contacts

• Study coordinator: Chwan-Li (Leslie) Shen, PhD
• Email: leslie.shen@ttuhsc.edu
• Phone: 806-743-2815

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.