Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000694819
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
7/06/2021
Date last updated
27/02/2023
Date data sharing statement initially provided
7/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Ageratum conyzoides on osteoarthritis in an ageing adult population: A double-blind randomized placebo-controlled parallel study.
Scientific title
Effect of Ageratum conyzoides on osteoarthritis in an ageing adult population: A double-blind randomized placebo-controlled parallel study.
Secondary ID [1] 304034 0
AEGART
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 321663 0
Condition category
Condition code
Musculoskeletal 319412 319412 0 0
Osteoarthritis
Alternative and Complementary Medicine 319791 319791 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320354 0
Treatment: Other
Comparator / control treatment
The placebo will consist of microcrystalline cellulose encapsulated in opaque capsules to appear identical to the A.conyzoides product. The placebo will be administered as per A.conyzoides (1 capsule in the evening with food).
Control group
Placebo

Outcomes
Primary outcome [1] 327271 0
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1)
Timepoint [1] 327271 0
Every 3 weeks post intervention (Baseline, Week 3, Week 6, Week 9, Week 12 (primary endpoint))
Secondary outcome [1] 394406 0
Change in Joint Pain Severity – Visual Analogue Scale (VAS)
Timepoint [1] 394406 0
For 3 days at baseline, then at weeks 3, 6, 9 and 12 (primary endpoint) post intervention (both morning and evening pain score for 7 days)
Secondary outcome [2] 394407 0
Change in Ageing Male Symptom Questionnaire (males only)
Timepoint [2] 394407 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention
Secondary outcome [3] 394408 0
Change in International Prostate Symptom Score (I-PSS) (males only)
Timepoint [3] 394408 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention
Secondary outcome [4] 394409 0
Change in Women’s Health Questionnaire (WHQ) (females only)
Timepoint [4] 394409 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention
Secondary outcome [5] 394410 0
Change in General Health Questionnaire (Short-Form Health Survey SF-36)
Timepoint [5] 394410 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention
Secondary outcome [6] 394412 0
Change in Hair density - Haircheck® Device
Timepoint [6] 394412 0
Baseline and Week 12 (primary endpoint) post intervention
Secondary outcome [7] 394413 0
Change in inflammatory markers (TNF-a, IL-6, IL-8, IL-10, hs-CRP, ESR as measured by plasma) as composite outcome
Timepoint [7] 394413 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention
Secondary outcome [8] 394414 0
Product tolerance using gastrointestinal symptom questionnaire
Timepoint [8] 394414 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention
Secondary outcome [9] 394415 0
Change in anthropometry (Blood pressure as measured by Omron Automatic Blood Pressure Machine, waist and hip circumference by measuring tape, height using the Seca 213 portable stadiometer and weight by Seca digital scales) as composite outcome.
Timepoint [9] 394415 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention
Secondary outcome [10] 396103 0
Safety as measured by liver function enzymes, AST, ALT, GGT, PSA (males only) via blood sample
Timepoint [10] 396103 0
Baseline, Week 6 and Week 12 (primary endpoint) post intervention

Eligibility
Key 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
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2021
Actual
21/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308416 0
Commercial sector/Industry
Name [1] 308416 0
Pharmako Biotechnologies Pty Ltd
Country [1] 308416 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3/76 Doggett street,
Newstead, QLD 4006
Country
Australia
Secondary sponsor category [1] 309250 0
Commercial sector/Industry
Name [1] 309250 0
Pharmako biotechnologies Pty Ltd
Address [1] 309250 0
2/2 Aquatic Drive
Frenchs Forest, NSW 2086
Country [1] 309250 0
Australia
Secondary sponsor category [2] 309251 0
Commercial sector/Industry
Name [2] 309251 0
Gencor Pacific
Address [2] 309251 0
21-E,Elegance
Hillgrove Village
Discovery Bay 999077
Hong Kong
Country [2] 309251 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308378 0
Bellberry Limited
Ethics committee address [1] 308378 0
Ethics committee country [1] 308378 0
Australia
Date submitted for ethics approval [1] 308378 0
31/03/2021
Approval date [1] 308378 0
14/09/2021
Ethics approval number [1] 308378 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110502 0
Dr Amanda Rao
Address 110502 0
RDC Clinical Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 110502 0
Australia
Phone 110502 0
+61 414 488 559
Fax 110502 0
Email 110502 0
[email protected]
Contact person for public queries
Name 110503 0
Amanda Rao
Address 110503 0
RDC Clinical Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 110503 0
Australia
Phone 110503 0
+61 414 488 559
Fax 110503 0
Email 110503 0
[email protected]
Contact person for scientific queries
Name 110504 0
Amanda Rao
Address 110504 0
RDC Clinical Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 110504 0
Australia
Phone 110504 0
+61 414 488 559
Fax 110504 0
Email 110504 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.