Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000776909
Ethics application status
Approved
Date submitted
20/07/2011
Date registered
22/07/2011
Date last updated
26/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating the efficacy of Eleutherococcus senticisus (Araliacae: Siberian ginseng) on the amelioration of the symptoms of overtraining syndrome in Ironman triathletes
Scientific title
A randomised controlled trial investigating the efficacy of Eleutherococcus senticisus (Araliacae: Siberian ginseng) on the amelioration of the symptoms of overtraining syndrome in Ironman triathletes
Secondary ID [1] 262671 0
Nil
Universal Trial Number (UTN)
U1111-1123-0477
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overtraining syndrome 268383 0
Condition category
Condition code
Other 268511 268511 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Alternative and Complementary Medicine 268520 268520 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eleutherococcus senticosus (Araliacae: Siberian ginseng). Two tablets each taken twice daily. Each tablet contains 1g of Eleutherococcus senticosus. Total daily dose of Eleuthrococcus senticosus is 4 g per day. Participants will take the tablets for the final 6 weeks of the 12 week trial. The first 6 weeks of the trial involves elucidating from the daily heart rate and core temperature measurement as well as the blood samples and time trials whether the individuals are at risk of developing overtraining syndrome or not. Participants will take the herbal remedy for a total of 6 weeks as this is the standard time that this rememdy is given. This will make it comparable to clinical situations.
Intervention code [1] 267014 0
Prevention
Intervention code [2] 267023 0
Treatment: Other
Comparator / control treatment
Placebo consisting of microcellulose coated to have an identical appearance to the intervention tablets
Control group
Placebo

Outcomes
Primary outcome [1] 269257 0
No decrease in performance times in the Ironman event. A performance decrement of 10% or greater of elapsed time in the Ironman event which cannot be explained by any other means (wind, waves, cureents, punctures, injuries) is regarded as overtraining syndrome.
Timepoint [1] 269257 0
12 weeks
Primary outcome [2] 269267 0
Performance decrease in time trials. These time trial consist of a 400m swim in a 50m heated outdoor pool, a 4 km run held on an enclosed, but open roofed running track, and a 20 km simulated time trial on a cycle ergometer using the Tacx System
Timepoint [2] 269267 0
0 weeks, 6 weeks and 12 weeks
Primary outcome [3] 269268 0
Changes in blood concentrations of corticotrophic releasing hormone (CRH), adrenocorticitrophic releasing hormone (ACTH) and cortisol
Timepoint [3] 269268 0
0 weeks, 6 weeks, 12 weeks
Secondary outcome [1] 279228 0
No jump in day to day waking pulse of 5 beats per minute or more. Pulse is taken manually by the participant and counted for one full minute
Timepoint [1] 279228 0
The pulse is taken daily and any jump in waking heart rate from one day to the next of 5 beats per minute or more is regarded as indicative of overtraining syndrome. The pulse rate is therefore assessed over the entire 12 week period
Secondary outcome [2] 279247 0
Daily waking rectal temperature is taken and monitored. Temperature is taken by an Omron electronic digital thermometer. No mercury is involved
Timepoint [2] 279247 0
Daily for 12 weeks. Changes in core temperature is taken as evidence that the hypothalamic control of core temperature has been altered
Secondary outcome [3] 279248 0
Any changes in blood concentration of CRH, ACTH and cortisol will be correlated to performce decrements
Timepoint [3] 279248 0
0 weeks, 6 weeks, 12 weeks

Eligibility
Key inclusion criteria
Athletes entered in an Ironman triathlon
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medically diagnosed conditions, medically diagnosed cognitive impairment, participants currently on prescribed medication for any condition except the oral birth control pill

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Double blind randomised placebo controlled trial. There is allocation concealment. The active remedy and the placebos will be given to the researchers supervisor located in the central administration who will allocate numbers by random number generator to containers. He will note what numbers are allocated to active substance or placebo. Neither the researcher nor the participants will have access to the numbering system nor whether it is placebo or active ingredient. This will only be given to the researcher after statistical analysis of the results are made.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants will be effectively differentiated into the control group and the active ingredient group. They will receive the intervention in the final 6 weeks of the study. Traditionally Eleutherococcus senticosus and other adaptogenic herbal remedies are only given for a 6 week period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267499 0
Self funded/Unfunded
Name [1] 267499 0
Damon Kendrick
Country [1] 267499 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 266543 0
Commercial sector/Industry
Name [1] 266543 0
Australian College of Physical Education
Address [1] 266543 0
1 Figtree Drive, Sydney Olympic Park, NSW 2127
Country [1] 266543 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269460 0
Endeavour College of Natural Health
Ethics committee address [1] 269460 0
170 Wellington Street
East Perth WA 6004
Ethics committee country [1] 269460 0
Australia
Date submitted for ethics approval [1] 269460 0
08/04/2011
Approval date [1] 269460 0
24/05/2011
Ethics approval number [1] 269460 0
1/11/0027
Ethics committee name [2] 269461 0
Murdoch University HREC
Ethics committee address [2] 269461 0
South Street
Murdoch WA 6150
Ethics committee country [2] 269461 0
Australia
Date submitted for ethics approval [2] 269461 0
11/08/2011
Approval date [2] 269461 0
Ethics approval number [2] 269461 0
EC00269

Summary
Brief summary
The hypothesis is that overtraining syndrome due to hypothalamic dysfunction and that Eleutherococcus will assist in preventing overtrainign syndrome. Evidence for hypothalamic dysfunction is made by changes in waking core body temperature, and also by measuring changes in corticotrophic releasong hormine (CRH) which is released by the hypothalamus in times of stress. This hormone CRH in turn stimulates the pituitary gland to release adrenocorticotrophic hormone (ACTH) which stimulates the adrenal cortex to release cortisol. Cortisol is a stress hormone. All three of these hormones are measured at 0, 6 and 12 weeks. The study will determine if there is any difference in these hormones between the control cohort and the active ingerdient cohort
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32903 0
Address 32903 0
Country 32903 0
Phone 32903 0
Fax 32903 0
Email 32903 0
Contact person for public queries
Name 16150 0
Damon Kendrick
Address 16150 0
10 Manners Street
East Victoria Park WA 6101
Country 16150 0
Australia
Phone 16150 0
+61410441306
Fax 16150 0
Email 16150 0
[email protected]
Contact person for scientific queries
Name 7078 0
Damon Kendrick
Address 7078 0
2/11 Pearce Street, Ermington NSW2115
Country 7078 0
Australia
Phone 7078 0
+61410441306
Fax 7078 0
Email 7078 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.