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

Miami, FL
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
No Placebo-Only Group

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.
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.
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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Closest Location:University of Miami - Miami Project to Cure Paralysis· Miami, FL

Who is running the clinical trial?

University of MiamiLead Sponsor
974 Previous Clinical Trials
423,170 Total Patients Enrolled
FloridaOTHER
9 Previous Clinical Trials
1,064 Total Patients Enrolled
Mark S Nash, PhDPrincipal InvestigatorUniversity of Miami
12 Previous Clinical Trials
410 Total Patients Enrolled

Media Library

Strength Training (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05776862 — Phase 2
Spinal Cord Injury Research Study Groups: UA and exercise in paraplegia group, UA in tetraplegia group
Spinal Cord Injury 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
~2 spots leftby Jun 2025
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