None listed
Conditions
Brief summary
ATLAS is a 12-week research study sponsored by the University of Sydney, evaluating the efficacy of an oral supplement combination for reducing knee pain compared to a placebo in people with symptomatic knee OA.
Interventions
- The intervention is a combined supplement composed of Boswellia serrata extract (BSE, Boswellin® Super) 250 mg/day, Pine bark extract (PBE, Fenoprolic ™ 70 Organic) 100 mg/day, Curcumin 500mg/day, Piperine 5mg/day and Methylsulfonylmethane (MSM) 1500 mg/day.
- The frequency and duration of the intervention is 4 capsules daily (2 capsules/morning and 2 capsules/night) for 12 weeks.
- The mode of administration is oral capsules.
- Treatment adherence will be measured weekly by the online, study
- The intervention is a combined supplement composed of Boswellia serrata extract (BSE, Boswellin® Super) 250 mg/day, Pine bark extract (PBE, Fenoprolic ™ 70 Organic) 100 mg/day, Curcumin 500mg/day, Piperine 5mg/day and Methylsulfonylmethane (MSM) 1500 mg/day. - The frequency and duration of the intervention is 4 capsules daily (2 capsules/morning and 2 capsules/night) for 12 weeks. - The mode of administration is oral capsules. - Treatment adherence will be measured weekly by the online, study-specific, self-reported questionnaire and by the patient-reported capsule count at the end of the study.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Be able and willing to participate and complete the study. - Have internet access and an active email account. - Have a fixed address in Australia for the duration of the study. - Have at least functional English (i.e., able to provide informed consent, understand study procedures, communicate with the research team, and complete questionnaires). - Be 40 years of age or older. - Have pain in the index knee for at least half of the days in the previous month before the online screening (If both knees are affected by OA, the index knee will be the most symptomatic. If both knees are equally affected, the study doctor will determine the index knee upon radiological assessment) - Have a moderate average index knee pain intensity over the week before the online screening and baseline assessment (i.e., = 40 and = 90 on a 0-100 Visual Analogue Scale (VAS)). - Be unsatisfied with the current symptomatic state [i.e., negative Patient acceptable symptom state (PASS)] before the online screening and baseline surveys. - Fulfil the clinical and radiographic criteria for knee OA according to the American College of Rheumatology using participant-reported symptoms/signs. - Have a Kellgren-Lawrence Grade (KLG) = 2 in the tibiofemoral (TF) or patellofemoral (PF) compartment based on an X-ray of the index knee - Be willing to maintain a routine (i.e., consistent dosage and frequency) of non-pharmacological and pharmacological therapies for the duration of the study. - Be willing to abstain from protocol-specified prohibited medications for the duration of the study. - Be willing to abstain from any supplements targeting osteoarthritis for the duration of the study.
Exclusion criteria
- Do not complete the submission of the online screening survey, leaving the form incomplete after 28 days. - Become non-responders after completing their online screening survey but before being enrolled in the study. - Have known hypersensitivity to the active or placebo components of the study products (i.e., Boswellia serrata extract, Curcumin, Piperine, Pine bark extract, MSM, and Microcrystalline cellulose USP) or other ingredients of the capsule (Gelatin and Titanium dioxide). - Are not willing to undergo a 48h washout before the weekly pain assessments. - Are not willing to discontinue products containing the active ingredients - Boswellia serrata extract, Curcumin (use of food spice is allowed), Piperine, Pine bark extract or MSM. - Regularly take centrally acting analgesics (e.g., opioid, duloxetine, pregabalin). - Are currently taking medications known to have potential pharmacological interaction with one or more supplements being tested. - Have a history of crystalline diseases [e.g., gout, calcium pyrophosphate deposition disease (CPPD)], autoimmune arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis), hemochromatosis or fibromyalgia. (Participants diagnosed with gout are eligible for the study as long as the condition is being appropriately treated and they have not experienced flare-ups for at least 12 months and participants diagnosed with hemochromatosis but with normal iron levels for at least 12 months are eligible for the study). - Are pregnant or breastfeeding, or a woman of childbearing potential but not willing to use contraceptive methods for the duration of the study. - Have any condition that could confound the participant's assessment of index knee pain in the investigator's judgment. For example, same-side hip pain referred to the knee, diabetic or peripheral neuropathy or knee pain referred from the back. - Have a history of knee infection diagnosis within one month of screening. - Had an acute knee injury to index knee within 6 months of screening. - Had surgery on the index knee in the past 6 months - Anticipate any invasive procedure (or surgery) on the index knee during the study duration. - Had previous intra-articular (IA) therapies (IA hyaluronic acid injection in the study knee in the past six months; IA steroid injections in any joint in the past six months; IA autologous blood product or stem cell injection in the study knee in the past 12 months). - Have any unstable concurrent clinically significant acute, chronic medical conditions or abnormal laboratory findings that, in the investigator's judgment, would jeopardise the participant's safety, interfere with the protocol's objectives, or affect the participant's compliance. - Have cancer or other tumour-like lesions (except non-melanoma skin cancer) which has been active in the last three years. - Are participating in another clinical trial or used an investigational drug or device within 30 days of screening.
Outcome results
None listed