What is this study about?
The MaRVeL trial is a research study aiming to see if Pentosan Polysulfate (PPS) can improve the knee pain and decrease the cholesterol levels in the bloodstream, and improve blood circulation to the knee joint. PPS is derived from the bark of the Beech tree.
It has been approved by the Therapeutic Goods Administration (TGA) in Australia and the Food and Drug Administration (FDA) in the US for more than twenty years as an oral medicine for chronic inflammation of the bladder wall. It has been used in Europe for many years as a mild blood thinner. It has also been reported to have a lipid-lowering property.
PPS is NOT approved by TGA for osteoarthritis and so we are conducting this study to understand the potential role of PPS in providing pain relief for people with knee osteoarthritis. If the study is suitable for you, you will have a 50% chance of being allocated to either group and receive:
Active group: oral dose of PPS taken every 4 days for 6 months
Placebo group: oral dose of placebo taken every 4 days for 6 months
As a participant, you will be asked to attend seven study visits and complete online surveys regularly over 6 months.
The study is suitable for people who:
- are aged 45 years or older
- are able to give written informed consent and to participate fully in the interventions and follow-up procedures
- are able to travel to Royal North Shore Hospital, St Leonards
- have a history of primary hypercholesterolemia and total fasting cholesterol above 5.0 mmol/L
- have confirmed knee Osteoarthritis and have symptoms of knee OA for at least 6 months prior to screening visit
- have knee pain on most days over the last month
- have a BMI <40
- agree to maintain their usual activity level and diet throughout the study
- agree to use adequate contraception prior to study entry and for the duration of study participation if female
This study has been approved by the Northern Sydney Local Health District Human Research Ethics Committee (HREC) – 2021/ETH00315
Am I eligible?
If you have knee pain due to osteoarthritis and live in Sydney, please complete the online screening survey available at MaRVeL study to assess your eligibility