NCT02157675

Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness

The Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness: a 2-arm, Randomized, Double-blind, Placebo-controlled, Crossover Design Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: NewChapter, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Delayed Onset Muscle Soreness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polyherbal capsule
DIETARY_SUPPLEMENT	Placebo capsule

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-06-06
• Last updated: 2015-10-14

Locations

1 site across 1 country: United States