| Eligibility |
Subjects must meet all of the following inclusion criteria to be eligible for enrollment:
Inclusion Criteria:
- Males and females between age 21 and 80 years of age.
- Symptoms of numbness or tingling for at least 4 weeks in at least two digits on one
hand that include thumb, index, long, or radial border of ring finger.
- Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram.
- A clinical diagnosis of carpal tunnel syndrome. Patients with bilateral CTS will have
the more severe hand enrolled.
- Able to complete English-language questionnaires and clinical evaluations.
- Willingness to avoid pregnancy.
- Female participants of childbearing potential must have a negative pregnancy test
at screening (serum) and before the first dose on Day 1 (urine), before the third
dose on Day 29 (urine), and 60 days after the final dose on day 60 (urine).
- Sexually active female participants of childbearing potential must agree to take
appropriate precautions to avoid pregnancy from screening until 30 days after the
last dose of study drug (day 60). Permitted methods in preventing pregnancy (see
Appendix A) will be communicated to the participants and their compliance
confirmed.
- All female participants of childbearing potential will refrain from donating
oocytes from screening-day 60 of the study.
- Women without child bearing potential (ie., surgically sterile with hysterectomy
and/or bilateral oophorectomy and/or bilateral salpingectomy OR = 12 months of
amenorrhea and at least 50 years of age) are eligible to participate without the
above precautions.
- Willing and able to comply with study procedures and requirements and attend all study
visits as defined in this protocol.
Exclusion Criteria
Subjects with any of the following exclusion criteria will not be eligible for enrollment:
General Exclusion Criteria:
- Unable or unwilling to give informed consent.
- Pregnant or breast feeding
- Previous carpal tunnel release on the study hand
- History of steroid injection into carpal tunnel or surgery on the affected wrist
within the past 6 months.
- Prisoners, institutionalized individuals, or others who may be considered vulnerable
populations, such as individuals with dementia.
Laboratory Exclusion Criteria:
The following laboratory tests as indicated or as per clinical judgement:
- Bilirubin > 2.0; serum aspartate transaminase (AST) > 4 X upper limit of normal, or
alanine aminotransferase (ALT) > 4 X upper limit of normal as a marker of liver
disease
- Hemoglobin < 7g/dL; white blood cell count =2,000/mm3 (=2.0 x 109/L) or =20,000/mm3
(=20 x 109/L); platelet count =40,000/µL (=40 x 109/L); absolute neutrophil count =1 x
109/L; lymphocyte count <0.3 x 109/L at screening as a marker of poor nutrition
- Plasma and/or serum fasting glucose > 300 or HbA1c > 9 as a marker of poor diabetic
control
- Creatinine >2.5, cystatin c >3 or eGFR< 25 ml/min/1.73 m2 as a marker of advanced
kidney disease,
- CRP > 10 or ESR >25 as a marker of systemic inflammation
- Unstable (as per clinical judgement) major cardiovascular, renal, endocrine,
immunological, or hepatic disorder
Clinical History Exclusion Criteria
- History of diverticulitis or diverticulosis with GI bleeding, as per clinical
judgement
- Any of the following clinical diagnosis or conditions: cervical radiculopathy, renal
failure (see laboratory exclusion criteria), liver disease (see laboratory exclusion
criteria), peripheral nerve disease, uncontrolled diabetes (see laboratory exclusion
criteria), or other metabolic disorder; as per clinical judgement
- Human immunodeficiency virus infection
- Known active hepatitis B or C infection
- Invasive fungal infection
- Uncontrolled (as per clinical judgement) pleural/pericardial effusions or ascites
- New/active invasive cancer except non-melanoma skin cancers
Medication Exclusion Criteria
- Known hypersensitivity or allergy to Fisetin or other flavonoids
- Currently participating in another study using Fisetin or currently taking any
flavonoid as a nutritional supplement. Note that consuming foods rich in flavonoids is
NOT an exclusion, both because flavonoids are present in almost all fruits and
vegetables, making such an exclusion impossible as a practical matter, and, from a
scientific perspective, the amount of flavonoids in general, and Fisetin in
particular, present in foods is far lower than the dose that will be administered in
the trial.
- Patients currently taking medications listed in the Investigator Brochure are excluded
unless medication can be safely held following the guidelines in the Investigator
Brochure.
- If the patient is required to initiate any medication listed in the Investigator
Brochure during the study, the PI will reassess their continued participation in the
study.
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