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Trial registered on ANZCTR
Registration number
ACTRN12625000037404
Ethics application status
Approved
Date submitted
19/12/2024
Date registered
16/01/2025
Date last updated
30/03/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of a topical curcumin formulation (VAS101) on knee pain in adults with knee osteoarthritis
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Scientific title
The effect of a topical curcumin formulation (VAS101) on knee pain in adults with knee osteoarthritis: A randomised, double-blind, placebo-controlled study
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Secondary ID [1]
313598
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None
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Universal Trial Number (UTN)
U1111-1317-0225
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee
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Condition category
Condition code
Musculoskeletal
332690
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0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The topical application of 0.1 millilitres of a gel containing curcumin (VAS101) to the target knee, once every 2 days for 28 days. Adherence to application will be monitored through daily responses to a questionnaire.
The the target knee (the knee to be treated in the trial) is the most painful knee. If both knees have similar pain, the most dominant leg will be established as the target knee and must meet all the eligibility criteria.
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Intervention code [1]
330196
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Treatment: Other
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Comparator / control treatment
A placebo gel similar in appearance and containing all ingredients except the active ingredient (curcumin)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Knee pain
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Assessment method [1]
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Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
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Timepoint [1]
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Days 0 (pre-commencment of intervention), 7, 14, and 28 (primary endpoint) post-interevention commencment
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Secondary outcome [1]
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Knee Pain
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Assessment method [1]
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Self-ratings of overall knee pain while walking for the day (1=no pain, 10=worst pain possible)
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Timepoint [1]
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Daily recrords from day 0 (pre-commencment of intervention) to day 27 post-interevention commencment
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Secondary outcome [2]
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Physical performance
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Assessment method [2]
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30-second Chair Stand Test
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Timepoint [2]
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Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
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Secondary outcome [3]
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Knee-related symptoms
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Assessment method [3]
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KOOS Symptom Score
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Timepoint [3]
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Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
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Secondary outcome [4]
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Physical performance
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Assessment method [4]
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Six-Minute Walk Test
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Timepoint [4]
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Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
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Secondary outcome [5]
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Physical performance
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Assessment method [5]
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Timed Up and Go Test
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Timepoint [5]
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Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
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Secondary outcome [6]
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Quality of life
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Assessment method [6]
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KOOS Quality of life score
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Timepoint [6]
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Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
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Secondary outcome [7]
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Daily living activity
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Assessment method [7]
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KOOS activities of daily living Score
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Timepoint [7]
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Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
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Secondary outcome [8]
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Subjective change in knee pain
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Assessment method [8]
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Patient Global Impression of Change
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Timepoint [8]
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Day 14, and day 28 post-intervention commencement
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Secondary outcome [9]
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Physical performance
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Assessment method [9]
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40m (4x10m) Fast-Paced Walk Test
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Timepoint [9]
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Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
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Secondary outcome [10]
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Intake of rescue medication
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Assessment method [10]
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Daily records of rescue medication intake
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Timepoint [10]
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Daily recrords from day 0 (pre-commencment of intervention) to day 27 post-interevention commencment
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Secondary outcome [11]
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Sports and recreational function
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Assessment method [11]
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KOOS Sports and recreation function score
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Timepoint [11]
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Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
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Secondary outcome [12]
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Marker of collagen breakdown
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Assessment method [12]
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Urinary Type II collagen cleavage products (CTX-II )
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Timepoint [12]
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Day 0 (pre-commencement of intervention) and day 28 post-intervention commencement
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Eligibility
Key inclusion criteria
1. Male or female
2. Aged 45 to 75 years (inclusive)
3. Clinical knee OA defined according to the National Institute for Health and Care Excellence (NICE) clinical criteria
a. age 45 years or older
b. has activity-related knee joint pain
c. has no morning knee stiffness or stiffness of 30 minutes or less
4. Body mass index (BMI) between 18.0 and 32.0 kg/m2
5. A previous diagnosis of knee OA by a medical practitioner
6. The knee OA can be unilateral or bilateral, but for participants with bilateral knee OA, the target knee (the knee to be treated in the trial) is the most painful knee. If both knees have similar pain, the most dominant leg will be established as the target knee and must meet all the eligibility criteria
7. At the time of screening, reports a knee pain rating of 4 to 7 on a 10-point numeric rating scale (1=no pain, 10=worst pain possible) to the following question: “Over the last week, what is your average knee pain while walking (1=no pain, 10=worst pain possible)”
8. Reports experiencing knee pain on more than 50% of days over the previous month
9. No plan to commence new treatments over the study period
10. Understand, willing and able to comply with all study procedures
11. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial
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Minimum age
45
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to hyper/hypotension, cardiovascular disease, diabetes, gastrointestinal disease, endocrine disease, neurological disease, cancer/ malignancy or other conditions that would jeopardise safety or impact validity of results (in the opinion the Investigator)
2. Suffers from arthritis of the hip or has chronic back pain that significantly affects daily function
3. Intra-articular treatment/injections with a corticosteroid or hyaluronic acid within 6 months before screening
4. Any surgery on the target knee within 6 months before screening
5. Any planned surgery during the study period
6. Clinically significant infection, injury, or illness within 28 days before screening
7. Planning to engage in heavy exercise (e.g., marathon run, heavy leg squats) within 48 hours before screening or during the study
8. Known allergic reaction to curcumin-containing products
9. Injury in the area of the target knee within 3 months before screening
10. Taking curcumin-containing products
11. Commencement of, or change in medication, herbal or vitamin supplements within 4 weeks before screening
12. Alcohol intake greater than 14 standard drinks per week
13. Current or 12-month history of regular illicit drug use
14. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant in the next 2 months.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
31/01/2025
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Actual
26/02/2025
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Date of last participant enrolment
Anticipated
31/05/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
60
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Accrual to date
22
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Vascarta Inc.
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Clinical Research Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Vascarta Inc.
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Address [1]
320424
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Country [1]
320424
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United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316718
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National Institute of Integrative Medicine Human Research Ethics Committee
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Ethics committee address [1]
316718
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https://niim.com.au/research/niim-human-research-ethics-committee
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Ethics committee country [1]
316718
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Australia
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Date submitted for ethics approval [1]
316718
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29/10/2024
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Approval date [1]
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19/12/2024
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Ethics approval number [1]
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0147E_2024
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Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 adults aged 40 to 75 years with knee osteoarthritis will be randomly assigned to receive either topical administrations of a gel containing curcumin (VAS101) or a placebo. These gels will be applied every 2 days for 28 days. Changes in knee pain and osteoarthritis symptoms will be examined using validated self-report measures, several performance-based tasks, and a urinary marker associated with disease progression in osteoarthritis. Changes in the use of rescue medications for knee pain will also be examined over time. It is hypothesised that compared to the placebo gel, the application of VAS101 will be associated with a greater reduction in knee pain and other knee-related osteoarthritis symptoms; and larger improvements in several performance-based tasks.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
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Australia
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Phone
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+61 08 94487376
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
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Australia
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Phone
138775
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+61 08 94487376
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Fax
138775
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Email
138775
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[email protected]
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Contact person for scientific queries
Name
138776
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Adrian Lopresti
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Address
138776
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
138776
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Australia
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Phone
138776
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+61 08 94487376
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Fax
138776
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Email
138776
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Case-by-case basis at the discretion of the study sponsor
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
Individual participant data underlying published results
What types of analyses could be done with individual participant data?
•
for IPD meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Access subject to approvals by Principal Investigator (
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
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.
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