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Trial registered on ANZCTR


Registration number
ACTRN12619000320156
Ethics application status
Approved
Date submitted
26/02/2019
Date registered
1/03/2019
Date last updated
31/05/2021
Date data sharing statement initially provided
1/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness and safety of a herbal formulation for the management of osteoarthritis of the knee
Scientific title
A 12-week randomised double blind clinical trial to assess the effectiveness and safety of a herbal formulation on knee pain among patients with osteoarthritis of the knee
Secondary ID [1] 296619 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 310427 0
Condition category
Condition code
Musculoskeletal 309144 309144 0 0
Osteoarthritis
Alternative and Complementary Medicine 309145 309145 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A standardised herbal formulation consisiting of Curcuma longa (Turmeric), Boswellia serrata (Indian frankincense) and Zingiber officinale (Ginger). Total active ingredients 300mg/tablet. 2 tablets morning and evening for the first 4 weeks, than 1 tablet morning and evening for the remaining 8 weeks of the trial.
Participants will receive 1 bottle at baseline which will contain 115 tablets for the 1st 4 weeks, with additional for compliance check. At 4 weeks participants will return any unused medication for compliance checks. They will be given the 2nd bottle of 115 tablets for the remaining 8 weeks, which will be return at week 12 for compliance check.
The labels on the bottles 1 and 2 will be specific with dosage instructions for the 4 week period and 8 week period respectively.
Participants will also fill out a diary daily recording the medication taken morning and night.
Intervention code [1] 313768 0
Treatment: Other
Comparator / control treatment
Placebo tablet, non-active ingredients. One or two tablets morning and evening as given in description of intervention.
Placebo tablet composition is a microcrystalline cellulose tablet
Control group
Placebo

Outcomes
Primary outcome [1] 319243 0
Pain using the 100mm visual analogue scale
Timepoint [1] 319243 0
average daily pain over 7 days on the 100mm VAS from baseline to week 12. 7 day assessments will be conducted 7 days prior to baseline, at week 4 and week 12.
Secondary outcome [1] 367406 0
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [1] 367406 0
Week 1, 4, 8 and 12 and followup at week 16
Secondary outcome [2] 367407 0
Participant Global Assessment (PGA) of arthritis questionnaire
Timepoint [2] 367407 0
Baseline and Week 12
Secondary outcome [3] 367409 0
Comprehensive Osteoarthritis Test (COAT) Questionnaire
Timepoint [3] 367409 0
Baseline, Days 1-7, week 4 and 12
Secondary outcome [4] 367525 0
Quality of life assessment using Short Form 12 (SF-12)
Timepoint [4] 367525 0
Baseline and Week 12
Secondary outcome [5] 367526 0
Physical performance test - 4 x 10 metre Fast Paced Walk Test
Timepoint [5] 367526 0
baseline, week 4 and week 12
Secondary outcome [6] 367527 0
Physical performance test - 30second Chair Sit to Stand test
Timepoint [6] 367527 0
baseline, week 4 and week 12
Secondary outcome [7] 367528 0
inflammatory blood marker - high sensitivity C-reactive protein (Hs-CRP)
Timepoint [7] 367528 0
Baseline and week 12
Secondary outcome [8] 367529 0
Blood Tests to assess safety of intervention - hepatic and renal function, full blood count and erythrocyte sedimentation rate
Timepoint [8] 367529 0
baseline and week 12
Secondary outcome [9] 380944 0
Pain VAS 100mm over 48 hours
Timepoint [9] 380944 0
Baseline, week 1, 4, 8, 12 and 16

Eligibility
Key inclusion criteria
1. Male or Female age 40 to 75
2. Clinical diagnosis of primary OA of the knee in at least one knee joint according to the American College of Rheumatology (ACR) for at least 3 months duration
3. Demonstration of radiological evidence of OA of the knee on the Kellgren and Lawrence scale Grades I to III
4. Average daily pain over 7 days to the affected knee on weight bearing activities between 30 to 80mm on a VAS (0 to 100mm) scale before baseline
5. BMI less than or equal to 35kg/m2
6. Participants normally active, not bedridden or confined to a wheelchair, able to walk 50m without the use of a walker, crutches or a cane
7. Participants able to understand and read and write in English
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of underlying inflammatory disease, arthropathy or rheumatoid arthritis or fibrosis where ESR>20 for men and >30 for women.
2. Gout or pseudogout within the last 3 months, and/or history of gout in the knee joint. Hyperuricaemia (440 micro mol/l) and /or high uric acid levels >380 micro mol/l
3. History of trauma to the knee affected by OA
4. Use of anticoagulants, systemic or intra-articular corticosteroid injections within the preceding 3 months; arthroscopy within preceding 3 months.
5. Hepatic or renal impairment within the last 6 months
6. Uncontrolled hypertension, congestive heart failure, malignancies, haematological disorders or neurological disorders
7. Have had major surgery in the past month or major surgery scheduled in the next 3 months
8. Pregnant or lactating females
9. Use of other supplements for OA (e.g. chondroitin, glucosamine, curcumin, omega-3 fatty acids)
10. Use of NSAID’s or analgesics for osteoarthritis including washout period of at least 3 days, including both oral and topical formulations
11. Disability by law (blindness, deafness, cognitive deficits, mental deficits, physical deficits)
12. Alcohol intake > 2 standard drinks per day

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)
Double-blind randomised controlled trial. Allocation is concealed and participants will be allocated a bottle with a randomisation number, which was added off site. The Investigators will have no knowledge of the randomisation code until the trial end,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
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
Safety/efficacy
Statistical methods / analysis
Data analysis will use descriptive statistics to examine the demographic and baseline characteristics. The primary VAS measure and secondary measures for active and placebo groups will be compared from baseline to week 12 using analysis of covariates (ANCOVA). The linear mixed model will be used to compare baseline scores of primary and secondary measures with those over the course of the 12 weeks of treatment for both active and placebo groups. All data will be presented as mean (SD). Statistical significance will be set at p<0.05. Both an intention-to-treat analysis and a per-protocol analysis will be conducted, the intention-to-treat analysis being of primary interest as it reflects better the effectiveness of the investigational product.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2019
Actual
18/09/2019
Date of last participant enrolment
Anticipated
30/08/2020
Actual
21/12/2020
Date of last data collection
Anticipated
30/12/2020
Actual
16/03/2021
Sample size
Target
90
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301196 0
University
Name [1] 301196 0
NICM Health Research Institiute, Western Sydney University
Country [1] 301196 0
Australia
Primary sponsor type
University
Name
NICM Health Research Institute, Western Sydney University
Address
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 300821 0
Commercial sector/Industry
Name [1] 300821 0
Blackmores Institute
Address [1] 300821 0
20 Jubilee Ave
Warriewood NSW 2102
Country [1] 300821 0
Australia
Secondary sponsor category [2] 301940 0
University
Name [2] 301940 0
Research Training Program Scholarship, Western Sydney University
Address [2] 301940 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country [2] 301940 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301937 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 301937 0
Research Engagement, Development and Innovation (REDI)
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 301937 0
Australia
Date submitted for ethics approval [1] 301937 0
30/01/2019
Approval date [1] 301937 0
05/06/2019
Ethics approval number [1] 301937 0
H13062

Summary
Brief summary
This study is a 12-week, randomised, double-blind, placebo controlled, clinical trial to assess the effectiveness and safety of a novel herbal formulation, consisting of Curcuma longa (Turmeric), Boswellia serrata (Indian Frankincense) and Zingiber officinale (Ginger) for the management of osteoarthritis of the knee.
The study will assess if taking this formulation helps reduce knee pain and improves function and wellbeing from osteoarthritis of the knee. It is expected that the herbal formulation will reduce pain from osteoarthritis of the knee over the course of 12 weeks compared to placebo medication.
Trial website
www.nicm.edu.au/kneepainstudy
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88622 0
Ms Christine Murray
Address 88622 0
NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 88622 0
Australia
Phone 88622 0
+61 2 9685 4700
Fax 88622 0
Email 88622 0
[email protected]
Contact person for public queries
Name 88623 0
Christine Murray
Address 88623 0
NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 88623 0
Australia
Phone 88623 0
+61 488228474
Fax 88623 0
Email 88623 0
[email protected]
Contact person for scientific queries
Name 88624 0
Christine Murray
Address 88624 0
NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 88624 0
Australia
Phone 88624 0
+61 2 9685 4700
Fax 88624 0
Email 88624 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
All individual data will remain confidential and de-identified. Only group trends will be used for analysis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2537Clinical study report  [email protected]



Results publications and other study-related documents

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