Effects of an Herbal Topical Cream on Osteoarthritis Symptoms, Biomarkers, and Disease Progression in the Knee
2 other identifiers
interventional
22
1 country
1
Brief Summary
Arthritis Relief Plus (ARP) Cream is a natural, herbal cream that has been shown to provide pain relief and decreased stiffness. Anecdotal reports suggest that pain may continue to be reduced months after cream use is stopped, indicating that there could be some disease-modifying effects of the cream. The purpose of this study is to test the claim that the ARP cream can provide long-term pain relief to osteoarthritis patients after only a short period of use. The study will also try to determine whether the pain relief is accompanied with any measurable indications that the progression of osteoarthritis has slowed or halted
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Dec 2008
1 active site
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
First Submitted
Initial submission to the registry
November 26, 2008
CompletedFirst Posted
Study publicly available on registry
December 1, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedSeptember 25, 2019
September 1, 2019
9 months
November 26, 2008
September 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
WOMAC
12 weeks
Secondary Outcomes (3)
Function
12 weeks
MRI morphology
12 weeks
Blood and urine biomarkers
12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo cream matched on consistency, color, and smell
Active
ACTIVE COMPARATORAARP active arthritis cream
Interventions
Eligibility Criteria
You may qualify if:
- Have a history of knee pain
You may not qualify if:
- Prior knee surgery
- History of knee or knee ligament instability
- History of intermittent or persistent knee joint swelling
- History of trauma to the knee or lower extremities resulting in fracture, tears of menisci, ligaments or joint capsule, or cartilage damage
- Unable to have MRI scan due to the presence of metallic internal devices that would represent a risk factor for MRI and known or suspected pregnancy.
- History of corticosteroid use
- Kidney Disease
- Knee diameter greater than 17cm and body diameter greater than 60 cm due to the physical constraints of the MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne L. Friedlander
Stanford University
- PRINCIPAL INVESTIGATOR
Garry Evan Gold
Stanford University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consulting Professor
Study Record Dates
First Submitted
November 26, 2008
First Posted
December 1, 2008
Study Start
December 1, 2008
Primary Completion
September 1, 2009
Study Completion
February 1, 2010
Last Updated
September 25, 2019
Record last verified: 2019-09