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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01827696
Other study ID # 001
Secondary ID
Status Completed
Phase Phase 1
First received April 4, 2013
Last updated March 1, 2016
Start date May 2013
Est. completion date December 2013

Study information

Verified date March 2015
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ginseng
Effect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise

Locations

Country Name City State
Canada University of Western Ontario London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Jung HL, Kwak HE, Kim SS, Kim YC, Lee CD, Byurn HK, Kang HY. Effects of Panax ginseng supplementation on muscle damage and inflammation after uphill treadmill running in humans. Am J Chin Med. 2011;39(3):441-50. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary muscle strength ginseng & muscle strength 1 month No
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