Trial Outcomes & Findings for A Study of Fisetin to Treat Carpal Tunnel Syndrome (NCT NCT05416515)

Last Updated: 2025-12-24

Results Overview

The Boston Carpal Tunnel Syndrome questionnaire (BCTQ) assesses symptom severity and overall function of subjects with Carpel Tunnel Syndrome. The questionnaire consists of two sections: 1. Symptom Severity (11 questions) and 2. Functional Status (8 questions). Subjects are asked to rate each question on a scale of 1 to 5. The mean score for each section is calculated by summing the individual question responses and diving by the number of questions resulting in a total score ranging from 1 to 5, with higher scores indicating greater symptom severity and dysfunction.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Baseline, 60 days

Results posted on

2025-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Carpal Tunnel Syndrome Adult men and women who had a clinical diagnosis for Carpal Tunnel Syndrome (CTS) received Fisetin for 2-day periods for 2 months. Fisetin: 100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Fisetin to Treat Carpal Tunnel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carpal Tunnel Syndrome n=40 Participants Adult men and women who had a clinical diagnosis for Carpal Tunnel Syndrome (CTS) received Fisetin for 2-day periods for 2 months. Fisetin: 100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
Age, Continuous	58.6 years STANDARD_DEVIATION 14.06 • n=30 Participants
Sex: Female, Male Female	20 Participants n=30 Participants
Sex: Female, Male Male	20 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants
Race (NIH/OMB) White	40 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Region of Enrollment United States	40 participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline, 60 days

Outcome measures

Outcome measures
Measure	Carpal Tunnel Syndrome n=40 Participants Adult men and women who had a clinical diagnosis for Carpal Tunnel Syndrome (CTS) received Fisetin for 2-day periods for 2 months. Fisetin: 100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
Change in Boston Carpal Tunnel Syndrome (BCTQ) Score	-0.5 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline, 60 days

Blood samples collected to measure percent decrease in circulating blood biomarkers of senescence

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 180 days

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

Outcome measures

Outcome data not reported

Adverse Events

Carpal Tunnel Syndrome

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Carpal Tunnel Syndrome n=40 participants at risk Adult men and women who had a clinical diagnosis for Carpal Tunnel Syndrome (CTS) received Fisetin for 2-day periods for 2 months. Fisetin: 100 mg capsules orally for 2 consecutive days and, after 1 month, another 2 consecutive days
Investigations Weight Gain	2.5% 1/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.
Gastrointestinal disorders Loose Bowels	2.5% 1/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.
General disorders Increased Pain	17.5% 7/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.
General disorders Surgery due to Continued Pain	15.0% 6/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.
Investigations C-Reactive Protein Level Increased	2.5% 1/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.
General disorders Increased Symptom Severity	12.5% 5/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.
Musculoskeletal and connective tissue disorders Leg Cramping	2.5% 1/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.
Nervous system disorders Headaches	2.5% 1/40 • Adverse events were collected from the time of investigational product administration through post-treatment follow up, approximately 180 days. Adverse event definition used in this study: An untoward or undesirable experience associated with the use of a medical product (i.e., drug, device, biologic) in a patient or research subject. Adverse events were collected through specific questioning and/or examination.

Additional Information

Peter Amadio, M.D.

Mayo Clinic

Phone: 507-538-1296

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place