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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
16/01/2025
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
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
Secondary ID [1] 313598 0
None
Universal Trial Number (UTN)
U1111-1317-0225
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 336141 0
Condition category
Condition code
Musculoskeletal 332690 332690 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330196 0
Treatment: Other
Comparator / control treatment
A placebo gel similar in appearance and containing all ingredients except the active ingredient (curcumin)
Control group
Placebo

Outcomes
Primary outcome [1] 340217 0
Knee pain
Timepoint [1] 340217 0
Days 0 (pre-commencment of intervention), 7, 14, and 28 (primary endpoint) post-interevention commencment
Secondary outcome [1] 443353 0
Knee-related symptoms
Timepoint [1] 443353 0
Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
Secondary outcome [2] 443354 0
Daily living activity
Timepoint [2] 443354 0
Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
Secondary outcome [3] 443355 0
Sports and recreational function
Timepoint [3] 443355 0
Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
Secondary outcome [4] 443356 0
Quality of life
Timepoint [4] 443356 0
Days 0 (pre-commencment of intervention), 7, 14, and 28 post-interevention commencment
Secondary outcome [5] 443357 0
Knee Pain
Timepoint [5] 443357 0
Daily recrords from day 0 (pre-commencment of intervention) to day 27 post-interevention commencment
Secondary outcome [6] 443358 0
Physical performance
Timepoint [6] 443358 0
Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
Secondary outcome [7] 443359 0
Physical performance
Timepoint [7] 443359 0
Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
Secondary outcome [8] 443360 0
Physical performance
Timepoint [8] 443360 0
Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
Secondary outcome [9] 443361 0
Physical performance
Timepoint [9] 443361 0
Day 0 (pre-commencement of intervention), day 14, and day 28 post-intervention commencement
Secondary outcome [10] 443362 0
Subjective change in knee pain
Timepoint [10] 443362 0
Day 14, and day 28 post-intervention commencement
Secondary outcome [11] 443363 0
Marker of collagen breakdown
Timepoint [11] 443363 0
Day 0 (pre-commencement of intervention) and day 28 post-intervention commencement
Secondary outcome [12] 443364 0
Intake of rescue medication
Timepoint [12] 443364 0
Daily recrords from day 0 (pre-commencment of intervention) to day 27 post-interevention commencment

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
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
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)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318069 0
Commercial sector/Industry
Name [1] 318069 0
Vascarta Inc.
Country [1] 318069 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 320424 0
Commercial sector/Industry
Name [1] 320424 0
Vascarta Inc.
Address [1] 320424 0
Country [1] 320424 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316718 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 316718 0
https://niim.com.au/research/niim-human-research-ethics-committee
Ethics committee country [1] 316718 0
Australia
Date submitted for ethics approval [1] 316718 0
29/10/2024
Approval date [1] 316718 0
19/12/2024
Ethics approval number [1] 316718 0
0147E_2024

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138774 0
Dr Adrian Lopresti
Address 138774 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138774 0
Australia
Phone 138774 0
+61 08 94487376
Fax 138774 0
Email 138774 0
[email protected]
Contact person for public queries
Name 138775 0
Adrian Lopresti
Address 138775 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138775 0
Australia
Phone 138775 0
+61 08 94487376
Fax 138775 0
Email 138775 0
[email protected]
Contact person for scientific queries
Name 138776 0
Adrian Lopresti
Address 138776 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138776 0
Australia
Phone 138776 0
+61 08 94487376
Fax 138776 0
Email 138776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of the study sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.