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Trial registered on ANZCTR


Registration number
ACTRN12608000629336
Ethics application status
Approved
Date submitted
1/10/2008
Date registered
12/12/2008
Date last updated
12/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of selected complementary and alternative medicines & therapies in the prevention and treatment of delayed onset muscle soreness (DOMS) and muscle damage in sub-elite athletes.
Scientific title
The efficacy of selected complementary and alternative medicines & therapies including Perna canaliculus, Harpagophytum procumbens, Arnica Gel, and Tienchi ginseng in the prevention and treatment of delayed onset muscle soreness (DOMS) and muscle damage in sub-elite athletes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed Onset Muscle Soreness 3780 0
Condition category
Condition code
Alternative and Complementary Medicine 3953 3953 0 0
Herbal remedies
Alternative and Complementary Medicine 3954 3954 0 0
Other alternative and complementary medicine
Musculoskeletal 3955 3955 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group 1: Perna canaliculus (green lipped muscle) – capsule form (50mg per capsule). Dosage 2 oral capsules in the morning and evening with meals for eight weeks prior to the down hill run and for three days after.

Intervention Group 2: Harpagophytum procumbens (Devil’s Claw) – liquid form (500mg per millilitre). Dosage 10ml orally daily for six weeks prior to the down hill run and four days after.

Intervention Group 3: Arnica Gel (10mg per gram) – topical application, directions to rub into the quadriceps straight after the down hill run and then every four hours (excluding sleeping hours) for five consecutive days.

Intervention Group 4: Tienchi ginseng – oral tablet form (1000mg per tablet). Dosage 4 tablets, four times daily. Taken 1 hour prior to the down hill run and then for the next consecutive four days.

The down hill run consists of 5 bouts of 8 minute down hill running (-10% gradient) with 2 minute rest intervals walking on the flat.
Intervention code [1] 3493 0
Prevention
Comparator / control treatment
Control Group 1 - Placebo in 50mg capsule form containing olive oil. Dosage is 2 oral capsules in the morning and evening with meals for eight weeks prior to the down hill run and for three days after.


Control Group 2 - Placebo in 500ml liquid form containing 45% ethanol, coloured and flavoured with gentian, chocolate brown colour and permacol black. Dosage 10ml orally daily for six weeks prior to the down hill run and four days after.


Control Group 3 – Placebo tube of clear base gel for topical application. Directions: rub into the quadriceps straight after the down hill run and then every four hours (excluding sleeping hours) for five consecutive days.


Control Group 4 – Placebo in oral tablet form (containing, calcium & magnesium salts, microcrystalline cellulose, sodium starch glycollate, colours & flavours). Dosage 4 tablets, four times daily. Taken 1 hour prior to the down hill run and then for the next consecutive four days.

The down hill run consists of 5 bouts of 8 minute down hill running (-10% gradient) with 2 minute rest intervals walking on the flat.
Control group
Placebo

Outcomes
Primary outcome [1] 4857 0
Increase or maintenance of performance through jump squat & Kinetic Communicator (Kin/Com).
Timepoint [1] 4857 0
6 weeks prior to the down hill run, baseline, 5 minutes post, 4 hours post, 24 hours post, 48 hours post down hill run.
Primary outcome [2] 4858 0
Pain measured subjectively and objectively through the Visual Analogue Scale (VAS) & algometer.
Timepoint [2] 4858 0
6 weeks prior to the down hill run, baseline, 5 minutes post, 4 hours post, 24 hours post, 48 hours post down hill run.
Secondary outcome [1] 8201 0
Identification of changes in the blood markers that may indicate inflammation and muscle degeneration. Blood analysis to identify the presence of muscle damage markers include Creatine Kinase and Myoglobin, Acute Phase Response Markers include Interleukin-1, Interleukin-6, Tumour Necrosis Factor-? and C-Reactive Protein that may indicate inflammation.
Timepoint [1] 8201 0
Baseline, 5 minutes post, 4 hours post, 24 hours post, 48 hours post the down hill run.

Eligibility
Key inclusion criteria
Trained athletes of sub-elite level
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Gastric and/or duodenal ulcers, or gallstones, allergies to shellfish products, diet excessive in fatty fish (i.e. high in eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) and omega 3 fatty acids)

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)
At session 1 (-6 weeks) all eligible participants will complete a beep test session which will be used to match subjects according to their DOMS response and anthropometric data (height, weight, body mass index, activity and training history). This will enable matching of participants before randomisation to minimise inter-individual variability. Participants will then be randomly assigned active or placebo medication by a computerised random number generator and matched up by an independent party to allow double blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by computer. Patients and investigating staff will be blinded to treatment allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Placebo controlled and four treatment arms.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3959 0
University
Name [1] 3959 0
University of Western Sydney
Country [1] 3959 0
Australia
Funding source category [2] 3960 0
Government body
Name [2] 3960 0
Australian Institute of Sport
Country [2] 3960 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC
NSW 1797
Country
Australia
Secondary sponsor category [1] 3551 0
Government body
Name [1] 3551 0
Australian Institute of Sport
Address [1] 3551 0
PO Box 176
Belconnen
ACT
NSW 2616
Country [1] 3551 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6028 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 6028 0
Locked Bag 1797
Penrith South DC
NSW 1797
Ethics committee country [1] 6028 0
Australia
Date submitted for ethics approval [1] 6028 0
Approval date [1] 6028 0
15/07/2004
Ethics approval number [1] 6028 0
HREC04/158
Ethics committee name [2] 6029 0
Australian Institute of Sport Ethics Committee
Ethics committee address [2] 6029 0
Ethics committee country [2] 6029 0
Australia
Date submitted for ethics approval [2] 6029 0
Approval date [2] 6029 0
20/08/2004
Ethics approval number [2] 6029 0
20040805

Summary
Brief summary
Delayed Onset Muscle Soreness (DOMS) and muscle damage are common and expected self-limiting sports training related conditions that can result in a loss of muscle force and significant pain. For athletes required to train and compete in close succession, DOMS can pose an obstacle to optimal performance. At present there are multiple methods for treating DOMS. Methods include; cryotherapy, anti-inflammatory medications, stretching, hypo-baric oxygen therapy, homeopathy, ultrasound, E-stimulation, L-carnitine, rest and light exercise. To date, a sound and consistent treatment for DOMS has not been established.

High-quality scientific research into Complementary and Alternative Medicines (CAM) and DOMS is limited despite the increase usage of such products by athletes. This is a randomised, double blind, placebo controlled trial that looks at four selected CAM’s in four sub-studies and their effect on DOMS and muscle damage in sub-elite athletes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28995 0
Address 28995 0
Country 28995 0
Phone 28995 0
Fax 28995 0
Email 28995 0
Contact person for public queries
Name 12152 0
Centre for Complementary Medicine Research
Address 12152 0
Locked Bag 1797
Penrith South DC
NSW 1797
Country 12152 0
Australia
Phone 12152 0
+61 2 4620 3284
Fax 12152 0
Email 12152 0
[email protected]
Contact person for scientific queries
Name 3080 0
Centre for Complementary Medicine Research
Address 3080 0
Locked Bag 1797
Penrith South DC
NSW 1797
Country 3080 0
Australia
Phone 3080 0
+61 2 4620 3284
Fax 3080 0
Email 3080 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

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