Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000976987
Ethics application status
Approved
Date submitted
2/09/2020
Date registered
30/09/2020
Date last updated
28/03/2022
Date data sharing statement initially provided
30/09/2020
Date results provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation into the effects of curcumin on osteoarthritis of the knee
Scientific title
An investigation into the effects of curcumin on osteoarthritis pain of the knee: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 302216 0
None
Universal Trial Number (UTN)
U1111-1257-8343
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 318912 0
Condition category
Condition code
Musculoskeletal 316891 316891 0 0
Osteoarthritis
Alternative and Complementary Medicine 316892 316892 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo capsules (1 capsule twice daily for 8 weeks)

Condition 2: Curcumin extract (Curcugen) (1 capsule containing 500mg, twice daily, delivering 1000mg a day, for 8 weeks)

Adherence to capsule intake will be monitored through capsule return and count.
Intervention code [1] 318508 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing either cellulose or rice powder) is matched to the curcumin capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 324995 0
Change in knee pain as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 324995 0
Weeks 0, 4, and 8 (primary timepoint)
Secondary outcome [1] 386487 0
Change in quality of life as assessed by the Patient-Reported Outcomes Measurement Information System® - 29 (PROMIS-29)
Timepoint [1] 386487 0
Weeks 0, 4, and 8
Secondary outcome [2] 386488 0
Change in knee pain as assessed by the Visual Analogue Scale (VAS)
Timepoint [2] 386488 0
Weeks 0, 1, 2, 3, 5, 6, 7, and 8
Secondary outcome [3] 386489 0
Change in functional status as assessed by the Japanese Orthopaedic Association (JOA)
Timepoint [3] 386489 0
Weeks 0 and 8
Secondary outcome [4] 386490 0
Change in physical performance and function as assessed by the 30-second chair stand test
Timepoint [4] 386490 0
Weeks 0 and 8
Secondary outcome [5] 386491 0
Change in physical performance and function as assessed by the 40m fast-paced walk test
Timepoint [5] 386491 0
Weeks 0 and 8
Secondary outcome [6] 386492 0
Change in physical performance and function as assessed by the six-minute walk test
Timepoint [6] 386492 0
Weeks 0 and 8
Secondary outcome [7] 386493 0
Change in physical performance and function as assessed by the timed up and go test
Timepoint [7] 386493 0
Weeks 0 and 8

Eligibility
Key inclusion criteria
1. Male and females aged 45 to 70 years
2. Meets the National Institute for Health and Care Excellence (NICE) clinical criteria for diagnosing knee osteoarthritis:
a. age 45 years or older
b. has activity-related knee joint pain
c. has morning knee stiffness that lasts no longer than 30 minutes
3. Knee osteoarthritis (diagnosed by a medical professional)
4. Reports knee pain on most days over the previous month
5. Has experienced knee pain for 3 months or more
6. Reports an average pain score of at least 6 on an 11-point numeric rating scale during walking over the previous week (0=no pain, 10=worst pain possible)
7. BMI between 20 and 35
8. Non-smoker
9. English speaking
10. No plan to commence new treatments over the study period
11. Willing to provide a personally-signed informed consent form detailing all pertinent aspects of the trial.
12. Willing and able to take prescribed capsules for 8 weeks
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Experience of rapid worsening of knee symptoms or the presence of a hot swollen knee
2. Previous knee replacement on the affected side or history of significant trauma to the knee
3. Has had major surgery in the last year
4. Has had a joint injection or arthroscopy in the past 6 months
5. Current or past (3 months) use of pain-relieving medications (e.g., NSAID’s, analgesics, and corticosteroids) greater than twice a week
6. Use of anticoagulants e.g. warfarin, apixaban, ticagrelor, rivaroxaban, dabigatran within the preceding 3 months
7. Diagnosis of gout or pseudogout within the last 3 months, and/or history of gout in the knee joint
8. Diagnoses of other inflammatory arthritides (for example, rheumatoid arthritis), septic arthritis, or malignancy (bone pain)
9. Diagnosis of complex pain disorder or severe immobility (e.g. complex regional pain syndrome, severe back pain, multiple sclerosis, muscular dystrophy, Parkinson’s disease, hemiplegic)
10. A recent diagnosis of and/or currently suffering from unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease/gallstones/biliary disease, endocrine disease, and malignancies
11. Diagnosis of a neurological disease (e.g., Parkinson’s disease, Alzheimer’s disease, intracranial haemorrhage, multiple sclerosis, or head/brain injury), psychiatric disorder (other than mild-to-moderate depression/anxiety)
12. Unable to walk unaided (without the use of a frame or walking stick) or is house-bound due to immobility
13. Alcohol consumption > 14 standard drinks per week
14. Current or 12-month history of illicit drug abuse
15. Currently taking supplements that may impact on treatment outcome (e.g. chondroitin, glucosamine, or curcumin)
16. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 10 randomly permuted blocks, containing 10 participants per block.
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies on herbal treatments for osteoarthritis, we are predicting an effect size of 0.6 compared to placebo. Based on this, a sample size of 72 is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 50 participants per group (100 participants in total), which should give us a suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:

1. Knee Injury and Osteoarthritis Outcome Score (KOOS)
2. Patient-Reported Outcomes Measurement Information System® - 29 (PROMIS-29)
3. Performance on performance-based tests (30-second chair stand test, 40m fast-paced walk test, 6-minute walk test, timed up and go test
4. Visual Analogue Scale (VAS)
5. Japanese Orthopaedic Association (JOA) Score

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2020
Actual
9/11/2020
Date of last participant enrolment
Anticipated
1/02/2021
Actual
16/02/2021
Date of last data collection
Anticipated
31/03/2021
Actual
16/04/2021
Sample size
Target
100
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306637 0
Commercial sector/Industry
Name [1] 306637 0
DolCas Biotech, LLC
Country [1] 306637 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 307188 0
None
Name [1] 307188 0
Address [1] 307188 0
Country [1] 307188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306822 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 306822 0
Ethics committee country [1] 306822 0
Australia
Date submitted for ethics approval [1] 306822 0
04/09/2020
Approval date [1] 306822 0
08/09/2020
Ethics approval number [1] 306822 0
007E_2020

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

Contacts
Principal investigator
Name 105130 0
Dr Adrian Lopresti
Address 105130 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 105130 0
Australia
Phone 105130 0
+61894487376
Fax 105130 0
Email 105130 0
[email protected]
Contact person for public queries
Name 105131 0
Adrian Lopresti
Address 105131 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 105131 0
Australia
Phone 105131 0
+61894487376
Fax 105131 0
Email 105131 0
[email protected]
Contact person for scientific queries
Name 105132 0
Adrian Lopresti
Address 105132 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 105132 0
Australia
Phone 105132 0
+61894487376
Fax 105132 0
Email 105132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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
SourceTitleYear of PublicationDOI
EmbaseAn investigation into the effects of a curcumin extract (Curcugen) on osteoarthritis pain of the knee: A randomised, double-blind, placebo-controlled study.2022https://dx.doi.org/10.3390/nu14010041
N.B. These documents automatically identified may not have been verified by the study sponsor.