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Do You Have Osteoarthritis of Your Knee?
Volunteers are needed to examine the effects of a topical gel containing curcumin on pain and symptoms associated with osteoarthritis of the knee.
This is a registered clinical trial with the Australian and New Zealand Clinical Trials Registry
This study is only available for people able to travel to our office in Duncraig, WA 6023
VAS101 is a gel that contains curcumin (derived from the plant turmeric). VAS101 is designed to be applied topically (on the skin). The oral intake of curcumin has been shown to have anti-inflammatory and pain-relieving effects; however, when applied topically, its pain-relieving effects have not been previously evaluated. The aim of this study is to investigate if the topical application of a curcumin-containing gel (VAS101) can help reduce pain and symptoms associated with osteoarthritis of the knee.
If you are between 45 and 75 years old and have been diagnosed with osteoarthritis of the knee, we invite you to participate in this randomised, controlled study.
PLEASE NOTE: Travel to our office located in Duncraig is required on 3 occasions over 4 weeks
Eligible participants will be RANDOMLY allocated into ONE of TWO treatment conditions:
- Application of a gel containing curcumin (VAS101) to your knee every 2 days, or or
- Application of a placebo (fake) gel
This 4-week study consists of the following:
1. Participate in a 10-minute phone interview to discuss the study and assess your eligibility to participate.
2. Have an X-ray on your target knee. We will arrange a referral to your nearest SKG pathology
3. Attend a face-to-face assessment on 3 occasions (baseline, week 2, and week 4) located in our offices in Duncraig. During your in-person visit (approx. 90 minutes), you will complete questionnaires, collect a small urine sample, and complete several low-intensity exercises to test your knee function.
4. Apply the gel to your knee every 2 days (containing curcumin or a placebo).
5. Complete online questionnaires every day. These questionnaires take less than a minute to complete on most days but on 2 days will take 10 minutes to complete.
You can download the full STUDY INFORMATION SHEET by clicking the button on this webpage
To compensate you for your time and travel costs, we will provide you with the following:
- $40 gift voucher at visit 1
- $40 gift voucher at visit 2
- $100 gift voucher at visit 3
- People placed on the placebo will be given a free supply of curcumin gel when the total recruitment for this study is completed
To be INCLUDED in the study, the following inclusion criteria must be met:
- You are between 45 and 75 years old.
- You experience symptoms of knee osteoarthritis.
- You have a body mass index (BMI) between 18 and 32 kg/m2
- You have previously been diagnosed with osteoarthritis of the knee by a medical practitioner
- You report a knee pain severity within our established cut-off severity
- You have knee pain on more than 50% of days over the previous month
- You have no plan to commence new treatments over the study period
- You understand and are willing and able to comply with all study procedures
- You are willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial
If any of the exclusion criteria below are met, the applicant will not be suitable for participation in this study:
- You suffer 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)
- You suffer from arthritis of the hip or have chronic back pain that significantly affects your daily function
- You have received intra-articular treatment/injections with a corticosteroid or hyaluronic acid within 6 months before screening
- Have had surgery on the target knee within 6 months before screening
- You plan to have surgery during the study period
- You have had a clinically significant infection, injury, or illness within 28 days before screening
- You plan to engage in heavy exercise (e.g., e.g., marathon run, heavy leg squats) within 48 hours before screening or during the study
- Have a known allergy to curcumin-containing products
- You have had an injury in the area of the target knee within 3 months before screening
- You currently take curcumin-containing products
- You have started or changed medication, herbal or vitamin supplements within 4 weeks before screening
- You consume more than 14 alcohol standard drinks per week
- You currently or in the last 12 months have regularly engaged in illicit drug use
- You are pregnant, breastfeeding, or planning to fall pregnant in the next 2 months.
This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0147E_2024)
If you are interested in participating in this study, please click on the button "Complete the Study Application Form" located on this webpage. This questionnaire will take aproximately 5 to 10 minutes to complete and helps us assess your eligibility to participate in this study.
Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately
If you would like to speak to a researcher to get more information about this study, you can call us on 08 9448 7376
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