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Subjects will have a bruise induced. A pad containing either a placebo or active will be applied to the bruise. Photographs will be taken over the following days to record bruise healing.
This is a randomized, double-blind, placebo-controlled, crossover, multicenter study that will be used to evaluate the difference in bruise reduction efficacy between active remedy and placebo when a mechanical bruise is induced. The trial will be conducted at 5-8 sites with up to 150 subjects. Each subject will be injured two times using the same bruise-inducing mechanism, and the resulting bruises will be treated with active remedy or placebo-infused pads that will be identical in appearance. Subjects and study investigators will be blinded to the order of treatment assignment. Subjects will be asked to come to the clinic for photographic assessments of the bruise. Each subject will be randomly assigned to have a placebo or active remedy pad applied over each mechanically induced bruise on Day 1. The pad will be applied by study staff immediately after bruise induction (within 5 minutes). The pad will cover the bruised area completely, and then sealed with Tegaderm. All procedures, including bruise induction, treatment, and photography, will be administered by study staff who are blinded to treatment type. All photographs will be rated according to standardized criteria by blinded, trained study investigators after the completion of all subject data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Arnica montana and Ledum palustre infused Pad |
|
| Placebo | Placebo Comparator | Pad (Matching appearance with Active) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arnica montana, Ledum palustre | Other | Homeopathic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Time to bruise healing in active vs. placebo | 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Blem | Contact | 858-945-6456 | jacqui@cardiffclinical.com |
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Aggregate data will be shared and published.
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| ID | Term |
|---|---|
| D003288 | Contusions |
| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000712347 | Arnicae flos extract |
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Treatment kits will be coded. An unblinded statistician will provide the treatment codes after the study database is locked.