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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00504010 |
Arnica in a topical gel formulation will be compared to a placebo to determine whether it decreases muscle soreness following leg exercise when applied to the legs.
Condition | Intervention | Phase |
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Muscles Exercise Arnica |
Drug: Arnica Montana Drug: placebo cream |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | The Role of Arnica on Muscle Pain Following Eccentric Exercise |
Enrollment: | 55 |
Study Start Date: | August 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
arnica containing cream
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Drug: Arnica Montana
Applied to lower extremity once a day for 3 days
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2: Placebo Comparator
carrier cream without arnica
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Drug: placebo cream
placebo cream applied to leg daily for 3 days
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Design: The design is a randomized, placebo-controlled, double-blind trial. Each participant will receive 2 containers of gel. One container will be marked "LEFT" and one "RIGHT." One container will contain a commercially available arnica gel formulation, and the other will contain a placebo gel, identical in appearance to the arnica. Subjects will not know which container contains which product. Each participant will also be given a form containing an analog pain scale for each leg. The participant will rate his or her pain in each leg separately on the day before exercise. Each subject will then be asked to perform calf raises using the following protocol:
Handrails are provided for safety and comfort
Neither subjects nor the researchers doing the data collection or analysis will know which gel is associated with which formulation (placebo vs. Arnica). Controls are within-subjects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Memorial Family Medicine | |
Houston, Texas, United States, 77074 |
Principal Investigator: | David W Bauer, MD | Memorial Hermann |
Responsible Party: | Memorial Hermann Healthcare System ( David W. Bauer, MD ) |
Study ID Numbers: | HSC-MH-07-0202 |
Study First Received: | July 17, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00504010 History of Changes |
Health Authority: | United States: Institutional Review Board |
arnica muscle soreness exercise eccentric |
Arnica Pain |