Muscle DamagePhase 1NCT01827696
Effect of American Ginseng on Exercise-induced Muscle Soreness
A Phase 1 study testing Ginseng in people with Muscle Damage, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Ginseng
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Injured
- Regular runners
- Pregnant (or with any chance they may become pregnant)
- Breast-feeding
- Diabetics or those taking medication for diabetes
- Insomniacs
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Muscle Damage
- Being tested
- Ginseng
- Keywords
- Muscle, Soreness, Muscle function, Damage, Ginseng
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GinsengDietary supplement
Effect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | American Ginseng ingestion Receives: Dietary Supplement: Ginseng |
| Placeobo | Placebo comparator | non-active ingredient Receives: Dietary Supplement: Ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
ginseng \& muscle strength
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Peter WR Lemon, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827696
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2015
- First submitted
- 4 Apr 2013
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21598413
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of American Ginseng on Exercise-induced Muscle Soreness
- ClinicalTrials.gov ID
- NCT01827696
- Acronym / sponsor ID
- 001
- Conditions
- Muscle Damage
- Keywords
- Muscle, Soreness, Muscle function, Damage, Ginseng
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: GinsengAmerican Ginseng ingestion |
| Placeobo | Placebo comparator | Dietary Supplement: Ginsengnon-active ingredient |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- Injured
- Regular runners
- Pregnant (or with any chance they may become pregnant)
- Breast-feeding
- Diabetics or those taking medication for diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GinsengEffect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise | Dietary supplement | Placeobo, Treatment |
Primary outcome
muscle strength
Time frame: 1 month
ginseng \& muscle strength
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Background: PubMed 21598413Jung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter WR Lemon, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ginseng in people with Muscle Damage, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01827696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.