- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01827696
Effect of American Ginseng on Exercise-induced Muscle Soreness
March 1, 2016 updated by: Peter Lemon, Lawson Health Research Institute
Healthy participants will ingest American ginseng daily or a placebo for four weeks prior to engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness.
Muscle soreness will be assessed via decrements in muscle strength and with a self-rating of perceived soreness before and several times after the exercise.
Study Overview
Detailed Description
Healthy men and women will consume either 2000 mg of American ginseng daily (four 500 mg pills will be taken at four different times during the day always with food/meals) or a placebo (4 cellulose) for four weeks prior to engaging in a 40 minute downhill treadmill jog (12% decline) at a speed of 7 miles per hour.
Participants will consume one pill with breakfast, one pill with lunch, one pill with dinner and another pill with a snack either between meals or prior to bedtime.
The exercise will be consist of five, eight minute bouts of jogging with two minutes of rest/recovery in between.
The degree of muscle soreness will be assessed using a Biodex strength testing machine (isometric and concentric isokinetic torque), and a self-rating of perceived soreness on a scale from zero to ten.
All of the above measures will be taken before and several times after the downhill jogging protocol.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- University of Western Ontario
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy men or women, (women must weigh between 55-65 kg., while men must weigh between 75-85kg).
- Participants must not have engaged in any endurance run training in the past 9 months.
Exclusion Criteria:
- Injured
- Regular runners
- Pregnant (or with any chance they may become pregnant)
- Breast-feeding
- Diabetics or those taking medication for diabetes
- Insomniacs
- Schizophrenics
- Hyper- or hypotension
- Cancer
- Irregular heartbeats
- Heart disease
- Females with endometriosis or uterine fibroids
- Those who have surgery scheduled during the study or within the two weeks following the completion of the study
- Those taking warfarin or medication for depression.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
American Ginseng ingestion
|
Effect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise
|
PLACEBO_COMPARATOR: Placeobo
non-active ingredient
|
Effect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle strength
Time Frame: 1 month
|
ginseng & muscle strength
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter WR Lemon, PhD, Western University, Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (ACTUAL)
November 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
April 4, 2013
First Submitted That Met QC Criteria
April 8, 2013
First Posted (ESTIMATE)
April 9, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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