Effect of Ursolic Acid of Loquat Extract on Function of Muscle
1 other identifier
interventional
54
0 countries
N/A
Brief Summary
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 3, 2015
October 1, 2015
3 months
March 24, 2015
October 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
quadriceps muscle function
12weeks
Secondary Outcomes (2)
ASM(appendicular skeletal mass) marker
12weeks
Short Physical Performance Battery, SPPB
12weeks
Study Arms (2)
UA group
EXPERIMENTALUA group who takes Ursolic acid of Loquat Extract , 500 mg/ day during 12 weeks for treatment of muscle function improvement with relatively health adults
placebo group
PLACEBO COMPARATORplacebo group who takes a placebo, 500 mg/day for 12 weeks
Interventions
Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks
Eligibility Criteria
You may qualify if:
- BMI 18.5-30KG/M2
You may not qualify if:
- \> SERUM creatinine 1.2mg/dL
- \> AST or ALT 60IU/L
- DM Patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Prissadova N, Bozov P, Marinkov K, Badakov H, Kristev A. Effects of ursolic acid on contractile activity of gastric smooth muscles. Nat Prod Commun. 2015 Apr;10(4):565-6.
PMID: 25973477RESULTCho YH, Lee SY, Kim CM, Kim ND, Choe S, Lee CH, Shin JH. Effect of Loquat Leaf Extract on Muscle Strength, Muscle Mass, and Muscle Function in Healthy Adults: A Randomized, Double-Blinded, and Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:4301621. doi: 10.1155/2016/4301621. Epub 2016 Nov 24.
PMID: 27999607DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SANG YEOUP Lee, Pf.
Pusan National University Yangsan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- family medicine
Study Record Dates
First Submitted
March 24, 2015
First Posted
March 27, 2015
Study Start
November 1, 2014
Primary Completion
February 1, 2015
Study Completion
October 1, 2015
Last Updated
November 3, 2015
Record last verified: 2015-10