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Flavonoid
Fisetin for Carpal Tunnel Syndrome
Phase 2
Recruiting
Led By Peter C Amadio, MD
Research Sponsored by Peter C. Amadio, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females between age 21 and 80 years of age
A clinical diagnosis of carpal tunnel syndrome. Patients with bilateral CTS will have the more severe hand enrolled
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 180 days
Awards & highlights
Study Summary
This trial is testing whether Fisetin is safe and effective for treating carpal tunnel syndrome.
Who is the study for?
Adults aged 21-80 with mild or moderate carpal tunnel syndrome can join this study. Women must not be pregnant, breastfeeding, or planning to become pregnant and should use birth control. Participants shouldn't have certain health conditions like severe liver disease, uncontrolled diabetes, recent wrist treatments, or be taking specific medications.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Fisetin for treating carpal tunnel syndrome. It aims to see if Fisetin can relieve numbness or tingling in fingers due to CTS by comparing symptoms before and after treatment.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions similar to other flavonoids since participants with known allergies to flavonoids are excluded from the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 80 years old.
Select...
I have been diagnosed with carpal tunnel syndrome in one or both hands.
Select...
I have had numbness or tingling in my fingers for over 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CTS symptoms
Secondary outcome measures
percent decrease in blood markers of cellular senescence in long-term
percent decrease in blood markers of cellular senescence, e.g., p16, IL-6, IL-15, TNF, PAI-1, ICAM-1, and additional exploratory, novel assays
Side effects data
From 2022 Phase 2 trial • 55 Patients • NCT047716117%
Rash
7%
hyperhidrosis
7%
Chest pain
7%
Diarrhea
7%
Sinusitis
7%
Infectious Rash
7%
Back Pain
7%
Headache
7%
Worsening Headache
7%
Dyspnea
7%
sore throat
3%
hypertension
3%
tachycardia
3%
amnesia
3%
asthma with exacerbation
3%
Anosmia
3%
migraine
3%
conjunctivitis
3%
rhinitis
3%
flu like symptoms
3%
Otitis media
3%
vertigo
3%
edema, hand, bilateral
3%
bacterial vaginosis
3%
ear pain, left
3%
cough
3%
Upper Respiratory Infection
3%
Epistaxis
3%
flatulence
3%
shortness of breath
3%
arthoplasty
3%
ageusia
3%
change in smell
3%
vomiting
3%
fatigue
3%
Colic Renal
3%
Nephrolithiasis Calcium Oxalate
3%
sneezing
3%
thrush
3%
right shoulder arthroscopy, rotator cuff, repair
3%
watering eyes (epiphora)
3%
Systolic murmur
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Carpal Tunnel SyndromeExperimental Treatment1 Intervention
Adult men and women who have a clinical diagnosis for Carpal Tunnel Syndrome (CTS) will receive Fisetin for 2 day periods for 2 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Peter C. Amadio, M.D.Lead Sponsor
Peter C Amadio, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Carpal Tunnel Syndrome
20 Patients Enrolled for Carpal Tunnel Syndrome
Peter C AmadioPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and have tested negative for pregnancy.My kidney function is severely impaired.My blood counts are outside the normal range, indicating possible poor nutrition.I have a condition like nerve disease, kidney failure, liver disease, uncontrolled diabetes, or another metabolic disorder.I will not donate eggs from the start of the study until 60 days after.I have an invasive fungal infection.I have fluid buildup that isn't managed by treatment.I have an active hepatitis B or C infection.I am between 21 and 80 years old.I have had diverticulitis or diverticulosis with bleeding.I am HIV positive.I do not have any unstable major health issues like heart, kidney, hormone, immune, or liver disorders.I am not currently in a study with Fisetin or taking flavonoid supplements.I have been diagnosed with carpal tunnel syndrome in one or both hands.I am not on any medications that conflict with the trial, or I can safely stop them.I have had numbness or tingling in my fingers for over 4 weeks.I have a new or active cancer, not including non-melanoma skin cancers.I have had surgery for carpal tunnel syndrome on my study hand.I haven't had steroid injections or surgery on my wrist in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Carpal Tunnel Syndrome
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research team currently have an open call for participants?
"Clinicaltrials.gov evidences that this clinical trial is actively recruiting; it was initially posted on October 9th 2022 and recently revised as of October 25th 2022."
Answered by AI
To what extent could Fisetin be detrimental to patients?
"With limited data concerning the efficacy of Fisetin, our team at Power gauged its safety as a 2 on a scale from 1 to 3."
Answered by AI
Who is eligible for inclusion in this experiment?
"Prospective participants in this clinical trial must meet two criteria: they must be between 45 and 80 years old, and they should have a diagnosis of carpal tunnel syndrome. 40 candidates are being sought for the study."
Answered by AI
Is this trial open to individuals above a certain age threshold?
"This research requires participants to be between 45 and 80 years old. For individuals that are under 18, there are 375 relevant trials, while those above 65 have access to 998 studies."
Answered by AI
What is the total participant recruitment for this clinical experiment?
"Correct. Clinicaltrials.gov indicates that this scientific research project, which was initially advertised on October 9th 2022, is actively recruiting participants. 40 individuals need to be sourced from 1 medical facility."
Answered by AI
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