ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1257-8343

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Alternative and Complementary Medicine

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]

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]

Change in knee pain as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timepoint [1]

Weeks 0, 4, and 8 (primary timepoint)

Secondary outcome [1]

Change in quality of life as assessed by the Patient-Reported Outcomes Measurement Information System® - 29 (PROMIS-29)

Timepoint [1]

Weeks 0, 4, and 8

Secondary outcome [2]

Change in knee pain as assessed by the Visual Analogue Scale (VAS)

Timepoint [2]

Weeks 0, 1, 2, 3, 5, 6, 7, and 8

Secondary outcome [3]

Change in functional status as assessed by the Japanese Orthopaedic Association (JOA)

Timepoint [3]

Weeks 0 and 8

Secondary outcome [4]

Change in physical performance and function as assessed by the 30-second chair stand test

Timepoint [4]

Weeks 0 and 8

Secondary outcome [5]

Change in physical performance and function as assessed by the 40m fast-paced walk test

Timepoint [5]

Weeks 0 and 8

Secondary outcome [6]

Change in physical performance and function as assessed by the six-minute walk test

Timepoint [6]

Weeks 0 and 8

Secondary outcome [7]

Change in physical performance and function as assessed by the timed up and go test

Timepoint [7]

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?

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)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

DolCas Biotech, LLC

Address [1]

9 Lenel Rd, Landing, NJ 07850, United States

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee

Ethics committee address [1]

11-23 Burwood Rd
Hawthorn VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/09/2020

Approval date [1]

08/09/2020

Ethics approval number [1]

007E_2020

Summary

Brief summary

In this randomised, double-blind, placebo-controlled study, 100 adults who are currently experiencing osteoarthritis of the knee will be randomly assigned to receive capsules containing either a curcumin extract (1000mg a day) or placebo for 8 weeks. We will assess changes in knee pain and quality of life via validated self-report measures (to be completed at various time points throughout the study). We will also evaluate pre and post changes in functional/physical performance via several performance-based tests.

Trial website

https://clinicalresearch.com.au/cra-studies/curcumin-osteoarthritis-study

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

adrian@clinicalresearch.com.au

Contact person for public queries

Name

Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

adrian@clinicalresearch.com.au

Contact person for scientific queries

Name

Adrian Lopresti

Address

Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023

Country

Australia

Phone

+61894487376

Fax

adrian@clinicalresearch.com.au

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 (adrian@clinicalresearch.com.au)

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

Source	Title	Year of Publication	DOI
Embase	An investigation into the effects of a curcumin extract (Curcugen) on osteoarthritis pain of the knee: A randomised, double-blind, placebo-controlled study.	2022	https://dx.doi.org/10.3390/nu14010041

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically