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| ID | Type | Description | Link |
|---|---|---|---|
| 2013138 |
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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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This study is a randomized, double-blind, placebo-controlled, crossover design study in healthy subjects to determine the effects of a polyherbal supplement on the signs and symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm.
Approximately 30 subjects will be enrolled. The study includes a 19-day treatment period and a minimum 7-day washout period in which no test product is administered. Subjects will then crossover to a second 19-day treatment period to complete the study. Subjects receive test product (polyherbal capsule or placebo capsule) daily during the treatment periods. Two exercise test sessions followed up to 5 days will occur during the study using a modified seated arm-curl bench. Muscle strength is assessed on each day of the 5-day exercise test period. Safety is assessed during the study by collecting adverse events (AEs), clinical laboratory data (serum hematology and chemistry), and vital signs (blood pressure, pulse, respiration rate, temperature).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyherbal capsule | Experimental | Subjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages. |
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| Placebo capsule | Placebo Comparator | Subjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyherbal capsule | Dietary Supplement |
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| Placebo capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in peak muscle strength on Day 2 of each test period after eccentric exercise. | This procedure utilizes 3 sets of 1 repetition of maximal isometric contractions of the arm recorded in pounds and averaged across the 3 sets. | Day 2 of each 5-day test period (ie, 48 hours after the eccentric exercise procedure to induce DOMS on Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in peak muscle strength after eccentric exercise | Up to 5 days following eccentric exercise. | |
| Change from baseline in pain assessment after eccentric exercise | Pain will be assessed verbally during elbow flexion and extension using a 10-point Likert scale (with 1 = normal, no discomfort and 10 = very uncomfortable). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05405 | United States |
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| Days 1-4 of each test period after eccentric exercise |
| Change from baseline in flexibility after eccentric exercise | Flexibility of the biceps muscle group will be evaluated with the arm hanging freely at the subject's side. The relaxed extension will be measured using an electronic level and electronic goniometer placed at the elbow. | Days 1-4 of each test period after eccentric exercise |
| Change from baseline in elbow girth (swelling) after eccentric exercise | Girth measurements will be taken around the elbow. | Days 1-4 of each test period after eccentric exercise |
| Change from baseline in muscle tenderness after eccentric exercise | Muscle tenderness scores will be assessed using a standard manual muscle myometer. Decreasing force application after baseline indicates increasing tenderness, a reflection of muscle damage. | Days 1-4 of each test period after eccentric exercise |
| Change from baseline in creatinine kinase (CK) and C-reactive protein (CRP) levels after eccentric exercise | Days 1-4 of each test period after eccentric exercise |