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Ursolic Acid + Strength Training for Muscle Atrophy and Insulin Resistance in Spinal Cord Injury

Phase 2
Recruiting
Led By Mark S Nash, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female individuals with chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7
Male and female individuals with paraplegia having chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights

Study Summary

This trial will test if a supplement can reduce muscle loss and improve blood sugar in people with spinal cord injuries.

Who is the study for?
This trial is for men and women with chronic spinal cord injuries, either paraplegia or quadriplegia, that have lasted more than a year. It's open to those with varying degrees of injury severity from specific regions of the spine (T2-T8 for paraplegia and C4-C7 for quadriplegia). Pregnant or breastfeeding individuals cannot participate.Check my eligibility
What is being tested?
The study is testing whether Ursolic Acid supplements can help reduce muscle loss and improve blood sugar control in people with chronic spinal cord injuries. Participants will also engage in strength training as part of the intervention.See study design
What are the potential side effects?
Potential side effects are not detailed here but generally, Ursolic Acid may cause mild discomfort such as nausea or skin rash, while strength training could lead to muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a spinal cord injury between C4-C7 for over a year.
Select...
I have had a spinal cord injury between T2-T8 for over a year, affecting my ability to move.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in muscle mass using Dual X-ray Absorptiometry (DXA)
Changes in fasting insulin resistance (IR)
Changes in glucose disposal
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: UA in tetraplegia groupExperimental Treatment1 Intervention
Participants will take UA 4 capsules twice daily for 12 weeks
Group II: UA and exercise in paraplegia groupExperimental Treatment2 Interventions
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ursolic Acid
2020
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
904 Previous Clinical Trials
410,210 Total Patients Enrolled
5 Trials studying Muscular Atrophy
3,220 Patients Enrolled for Muscular Atrophy
FloridaOTHER
9 Previous Clinical Trials
1,064 Total Patients Enrolled
1 Trials studying Muscular Atrophy
100 Patients Enrolled for Muscular Atrophy
Mark S Nash, PhDPrincipal InvestigatorUniversity of Miami
11 Previous Clinical Trials
394 Total Patients Enrolled

Media Library

Strength Training (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05776862 — Phase 2
Muscular Atrophy Research Study Groups: UA and exercise in paraplegia group, UA in tetraplegia group
Muscular Atrophy Clinical Trial 2023: Strength Training Highlights & Side Effects. Trial Name: NCT05776862 — Phase 2
Strength Training (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05776862 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to minors?

"To be eligible for participation, applicants must fall within the 18-65 year age bracket."

Answered by AI

Who is a likely candidate to participate in this experiment?

"To be eligible to participate in this study, patients must have a diagnosis of spinal cord injury and meet the age requirements of 18-65. Currently, researchers are seeking 20 participants for their clinical trial."

Answered by AI

Is this research actively seeking new participants?

"According to the data on clinicaltrials.gov, this trial is not currently accepting applicants. This research was first posted in April 1st of 2023 and last updated in March 7th of 2023; however, there are 1227 other medical trials that require participants as we speak."

Answered by AI

Has the Federal Drug Administration sanctioned a combination of physical activity and UA for paraplegia patients?

"Given the lack of efficacy data and presence of safety data, our team at Power rates UA and exercise in paraplegia group as a safe 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
Mark S. Nash, Ph.D., FACSM 2023. "Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776862.
~9 spots leftby May 2025
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