ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001467123

Ethics application status

Approved

Date submitted

3/10/2019

Date registered

23/10/2019

Date last updated

19/02/2021

Date data sharing statement initially provided

23/10/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of Palmitoylethanolamide (PEA) or Curcumin on Joint Health in an adult population when compared to a placebo - a randomised, double blind interventional study.

Scientific title

Joint Health in an Adult Population - PEA or Curcumin Compared to a Placebo in A
randomised, double-blinded study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Joint Pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is Palmitoylethanolamide (PEA) or Curcumin (2 arm study).

Participants will take 1 capsule containing 175 mg of PEA twice daily for 2 weeks (1 capsule in the morning and 1 capsule in the evening).

OR

One capsule containing a total 500 mg of HydroCurc taken daily in the evening before bed for 2 weeks.

Compliance will be monitored via capsule return at the end of the study.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

In this study there are two placebo comparator groups:
Placebo - PEA: The placebo product will be maltodextrin encapsulated in an opaque capsule. It will appear identical to the test products. It will be administered as two capsules using the same procedure detailed above for PEA.

OR

Placebo - Curcumin: The placebo product will be maltodextrin encapsulated in an opaque capsule. It will appear identical to the test products. It will be administered as a single capsule using the same procedure detailed above for curcumin.

Compliance will be monitored via capsule return at the end of the study.

Control group

Placebo

Outcomes

Primary outcome [1]

Change in joint pain as measured by Visual Analog Scale (VAS).

Timepoint [1]

Baseline, Daily for 2 weeks

Secondary outcome [1]

Change in weight as measured by digital scales

Timepoint [1]

Baseline, Day 14

Secondary outcome [2]

Change in quality of life as measured by SF-36, POMS and GI tolerance questionnaires.

Timepoint [2]

Baseline, Day 14

Secondary outcome [3]

Composite outcome: Change in systemic inflammation as measured by TNF-a, TGF-b, IL-1B, IL-6, IL-8, IL-10, hs-CRP with analysis by serum assay.

Timepoint [3]

Baseline, Day 14

Secondary outcome [4]

Composite outcome: General safety markers using E/LFT panel: Albumin, alkaline phosphatase, ALT, AST, GGT, cholesterol, HLD, LDL, triglycerides, urea, creatinine, glucose and total protein. Analysis via serum assay.

Timepoint [4]

Baseline, Day 14

Eligibility

Key inclusion criteria

Male and females 25-70 years old
Reporting joint pain (not associated with acute injury or long-standing disease)
Generally healthy
Able to provide informed consent
If female, must use either a prescribed form of birth control, are abstinent or post-menopausal
Agree not to change current diet or exercise during the study
Agree not to take any pain medication during the study

Minimum age

25 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland
function Malignancy)*
Malignancy or treatment for malignancy within the previous 2 years
Diagnosed rheumatoid arthritis, bursitis and/or gout
Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other
anticoagulation therapy
Serious mood disorders or neurological disorders such as MS
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (more than 14 standard alcoholic drinks week)
Allergic to any of the ingredients in 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.

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

Other design features

Phase

Phase 3 / Phase 4

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

12/10/2019

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

160

Accrual to date

156

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Gencor Pacific

Address [1]

Unit 3, 1/F, Office Building Block 2,
96 Siena Avenue, Discovery Bay North,
Lantau Island, N.T., Hong Kong

Country [1]

Hong Kong

Primary sponsor type

Commercial sector/Industry

Name

RDC Global Pty Ltd

Address

3B/76 Doggett Street
Newstead, QLD, 4006

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Pharmako Biotechnologies Pty Ltd

Address [1]

36 Campbell Ave, Cromer NSW 2099

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee Fullboard

Ethics committee address [1]

123 Glen Osmond Road, Eastwood, South Australia, 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/09/2019

Ethics approval number [1]

Summary

Brief summary

This is a double-blind, randomised, clinical study with a 14-day treatment duration with 2 arms (with 2 active ingredient groups and 2 placebo groups). The aim of this study is to assess the effectiveness of PEA and curcumin on reducing joint pain in otherwise healthy adults aged 25-70 years, compared to a placebo. A placebo is a substance with no therapeutic effect, in this case maltodextrin. 

Participants will be asked to attend our clinic to complete their enrolment with a Trial Coordinator. During this visit, they will also complete an initial assessment including, letting the trial coordinator know about their joint pain and general health by completing questionnaires; height and weight measurements; and a blood test.
At the conclusion of the visit, participants will be randomly allocated to either the PEA, curcumin or placebo treatment group.

Once enrolled in the study, participants will be asked to complete 3 days of pain recording (once morning and once at night) online. 
Following the completion of the 3 days of pain recording, trial coordinators will confirm supplementation commencement. Capsules should be consumed as described on the label. 
Once supplementation has started, participants will be required to record their pain level every morning upon waking, and every night prior to going to bed for 2 weeks. 
At the completion of the 2 weeks, participants will be required to attend the clinic for a final appointment where they will complete identical assessments to the initial visit.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Briskey

Address

RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006

Country

Australia

Phone

+61 421 784 077

Fax

d.briskey@uq.edu.au

Contact person for public queries

Name

Amanda Rao

Address

RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006

Country

Australia

Phone

+61 414 488 559

Fax

amanda@rdcglobal.com.au

Contact person for scientific queries

Name

Amanda Rao

Address

RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006

Country

Australia

Phone

+61 414 488 559

Fax

amanda@rdcglobal.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5202	Ethical approval					378498-(Uploaded-03-10-2019-13-35-22)-Study-related document.pdf

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	The Effect of a Dispersible Curcumin (HydroCurc) Compared to a Placebo for Reducing Joint Pain in an Adult Population - A Randomised, Double-Blind Study.	2022	https://dx.doi.org/10.1159/000524689

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

Trial Review

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Documents added manually

Documents added automatically