NCT01827696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

April 4, 2013

Last Update Submit

March 1, 2016

Conditions

Keywords

MuscleSorenessMuscle functionDamageGinseng

Outcome Measures

Primary Outcomes (1)

  • muscle strength

    ginseng \& muscle strength

    1 month

Study Arms (2)

Treatment

EXPERIMENTAL

American Ginseng ingestion

Dietary Supplement: Ginseng

Placeobo

PLACEBO COMPARATOR

non-active ingredient

Dietary Supplement: Ginseng

Interventions

GinsengDIETARY_SUPPLEMENT

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

PlaceoboTreatment

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

Related 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. doi: 10.1142/S0192415X11008944.

    PMID: 21598413BACKGROUND

MeSH Terms

Interventions

Asian ginseng

Study Officials

  • Peter WR Lemon, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 9, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

March 3, 2016

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations