None listed
Conditions
Brief summary
Effect of Ageratum conyzoides on osteoarthritis in an ageing adult population: A double-blind randomized placebo-controlled parallel study. The aim of this study is to assess the effectiveness of a pyrrolizidine alkaloid-free A. conyzoides extract on alleviating osteoarthritis symptoms and measures of quality of life in a healthy, ageing adult population. It is hypothesised that A.conyzoides will improve symptoms of osteoarthritis such as pain, joint function and inflammation while also improving quality of life.
Interventions
This is a double blind, randomised, placebo-controlled clinical study assessing the effectiveness of a pyrrolizidine alkaloid-free A. conyzoides extract on alleviating osteoarthritis symptoms and measures of quality of life in a healthy, ageing adult population. The study has 12-weeks participation and 2 groups (1 active group and 1 placebo group).
Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group or the active intervention group on 1:1
This is a double blind, randomised, placebo-controlled clinical study assessing the effectiveness of a pyrrolizidine alkaloid-free A. conyzoides extract on alleviating osteoarthritis symptoms and measures of quality of life in a healthy, ageing adult population. The study has 12-weeks participation and 2 groups (1 active group and 1 placebo group). Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group or the active intervention group on 1:1 chance basis (50%). Height, weight, waist and hip circumferences, hair thickness and blood pressure will be measured, and questionnaires will be completed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment inflammatory blood markers. Once the participant starts taking the capsules, they will be instructed to take the allocated product once daily in the evening with food. Dosage is the same for both the active product (A. conyzoides extract 250mg daily) and the placebo. In addition, participants will be asked to complete regular questionnaires regarding their osteoarthritis symptoms (WOMAC) and questionnaires regarding their joint pain (VAS for pain). Participants will be required to score their morning and evening pain daily using VAS to account for pain variability common among OA sufferers. They will also be asked to fill in a diary documenting any use of rescue medication (paracetamol/ibuprofen). Participants will undertake an additional blood test at week 6 and repeat all baseline measures at the completion of the trial. At all clinic visits and as part of the assessment, participants will be asked to complete relevant QOL questionnaires and provide details regarding any lifestyle changes (diet, exercise, medication). Participants will be monitored for compliance with the protocol by a combination of telephone and email communications in addition to during each scheduled visit.
Sponsors
RDC Global Pty Ltd
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
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults aged 45 years and above • Clinical diagnosis of osteoarthritis by a health professional • Reporting joint pain (not associated with acute injury, long-standing disease [other than osteoarthritis] or prescription medication use): equal to or greater than 10mm on visual analogue scale (VAS) for pain • BMI equal to or less than 35 • Able to provide informed consent • Agree not to change current diet and exercise program while enrolled in this trial • Agree not to undertake another clinical trial while enrolled in this trial
Exclusion criteria
• Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)* • Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years • Clinically significant acute or chronic inflammation, or connective tissue disease including, but not limited to, rheumatoid arthritis, tendinitis, bursitis, fibromyalgia or gout. • A history of knee or hip surgery and/or trauma within the previous 12 months • Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy • Receiving treatment for joint pain including but not limited to corticosteroid and hyaluronic acid use/injection, or taking supplements for joint pain/health such as glucosamine, chondroitin, curcumin and omega-3 containing products#. • Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse • Chronic past and/or current alcohol use (greater than 14 alcoholic drinks week) • Allergic to any of the ingredients in the active or placebo formula • Known pregnant or lactating woman • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion • Participants who have participated in any other related clinical study during the past 1 month • History of infection in the month prior to the study *An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. #Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.
Outcome results
None listed