Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000517976
Ethics application status
Approved
Date submitted
18/05/2011
Date registered
18/05/2011
Date last updated
9/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Safety and Efficacy Trial to Assess Green-Lipped Mussel extract in the treatment of Osteoarthritis of the Knee
Scientific title
A Pilot Trial Assessing the Safety and Efficacy of GlycOmegaTM PLUS [Green-Lipped Mussel Powder] for Osteoarthritis of the Knee.
Secondary ID [1] 262195 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 265877 0
Condition category
Condition code
Alternative and Complementary Medicine 266034 266034 0 0
Other alternative and complementary medicine
Musculoskeletal 266035 266035 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New Zealand Green-Lipped Mussel extract 500mg per capsule
dose: 3000mg per day (3 caps twice per day)
duration: 8 weeks
Intervention code [1] 264597 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266779 0
Lequesne Index - Provides an index of severity for OA of the knee. The Lequesne index is a 10-question interview-style survey given to patients with OA of the knee. It assesses pain or discomfort, maximum distance walked and activities of daily living. The total questionnaire is scored on a 0 to 24 scale, with lower scores indicating less functional impairment.
Timepoint [1] 266779 0
baseline (T0), week 4 (T4) and week 8 (T8)
Primary outcome [2] 266780 0
The Western Ontario and McMaster Universities (WOMAC) index is used to assess patients with OA of the hip or knee assessing pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. The total questionnaire is scored on a 0 to 96 scale with lower scores indicating a lesser degree of pain, stiffness, or physical dysfunction.
Timepoint [2] 266780 0
T0, T4, T8 weeks
Primary outcome [3] 266781 0
Gastrointestinal Symptom Rating Scale (GSRS):
The GSRS is a validated disease-specific questionnaire designed to evaluate common GI symptoms. The GSRS comprises 15 symptoms and uses a 7-point Likert scale in which 1 represents the most positive option and 7 the most negative. The items are combined into five clinical syndromes: abdominal pain, gastro-oesophageal reflux, indigestion, diarrhoea and constipation. Using a scoring algorithm, a GSRS total score is calculated
Timepoint [3] 266781 0
T0, T4, T8 weeks
Secondary outcome [1] 276377 0
The Short Form -12 [SF-12] Health Survey:
The SF-12 Health Survey measures generic health concepts relevant across age, disease and treatment groups. It provides a comprehensive, psychometrically sound and efficient way to measure heath from the patients point of view by scoring standardized responses to standard questions.
Timepoint [1] 276377 0
T0, T4, T8 weeks

Eligibility
Key inclusion criteria
- Knee osteoarthritis diagnosed by Rhuematologist
- not taking any form of herbal/multivitamin/nutritional supplements (i.e. glucosamine, fish oil, green-lipped mussel) 4 weeks before recruitment
- in otherwise good health
-
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- concurrent use of any other investigational product
- unintended weight loss of more than 15% of body weight within 6 months before recrutiment
- active substance abuse (alcohol or drug dependency)
- breast feeding, pregnant or planning to become pregnant
- smokers
- allergy/intolerances to shellfish (mollusk or crustaceans)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are recruited from the Director of Rheumatology's patient data base at the Princess Alexandra (PA) Hospital, Brisbane who then confirms they have osteoathritis (OA) of the knee. Advertisements are also placed in public areas within the PA hospital and patients sources from advertisements are then diagnosed with OA of the knee by the Rheumatologist at the PA hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4016 0
4000

Funding & Sponsors
Funding source category [1] 267099 0
Commercial sector/Industry
Name [1] 267099 0
Aroma New Zealand Ltd
Country [1] 267099 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Good Health Australia Pty Ltd
Address
Doyle Street
Bardon Ridge 2234
NSW
Country
Australia
Secondary sponsor category [1] 264184 0
University
Name [1] 264184 0
The University of Queensland
Address [1] 264184 0
St Lucia
Brisbane QLD 4072
Country [1] 264184 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267075 0
The University of Queensland HREC
Ethics committee address [1] 267075 0
St Lucia
Brisbane QLD 4072
Ethics committee country [1] 267075 0
Australia
Date submitted for ethics approval [1] 267075 0
01/02/2009
Approval date [1] 267075 0
19/03/2009
Ethics approval number [1] 267075 0
2009000148

Summary
Brief summary
The purpose of the study is to assess whether a high dose, stabilised green-lipped mussel extract is effective in the treatment of osteoarthritis of the knee, assessed by pain, mobility, gastrointestinal function and quality of life measures. We hypothesis that altered gut function (i.e. such as constipation, diarrhoea, reflux, bloating) may affect how successful green-lipped mussel is in improving the knee pain and mobility. Gut function may be altered due to the underlying condition of osteoarthritis, medication intake or altered gut flora.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32620 0
Address 32620 0
Country 32620 0
Phone 32620 0
Fax 32620 0
Email 32620 0
Contact person for public queries
Name 15867 0
Luis Vitetta
Address 15867 0
The Princess Alexandra Hospital
Lvl 2, R Wing
Centres for Health Research
199 Ipswich RD
Woolloongabba 4102
QLD
Country 15867 0
Australia
Phone 15867 0
+6 07 3176 2903
Fax 15867 0
+6 07 3176 6858
Email 15867 0
[email protected]
Contact person for scientific queries
Name 6795 0
samantha coulson
Address 6795 0
The Princess Alexandra Hospital
Lvl 2, R Wing
Centres for Health Research
199 Ipswich RD
Woolloongabba 4102
QLD
Country 6795 0
Australia
Phone 6795 0
+6 07 3176 5273
Fax 6795 0
+6 07 3176 6858
Email 6795 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.