Effect of Ageratum conyzoides on osteoarthritis in an ageing adult population: A double-blind randomized placebo-controlled parallel study.

Phase 3

Recruiting

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12621000694819
• Lead Sponsor: RDC Global Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified