ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000280606

Ethics application status

Approved

Date submitted

8/03/2023

Date registered

15/03/2023

Date last updated

25/06/2024

Date data sharing statement initially provided

15/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Oral safety and tolerability of Eucalypt and Corymbia sap resins in healthy adults
– A randomised controlled study

Scientific title

Oral safety and tolerability of Eucalypt and Corymbia sap resins in healthy adults
– A randomised controlled study

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1289-5155

Trial acronym

Linked study record

Health condition

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

Irritable bowel syndrome - D

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

100% purified sap resin capsules (each arm is given a different species of sap resin).
Oral self-administration of 1 capsule 3 times per day for 14 days.
Arm A 100% purified sap resin from Eucalyptus tetrodonta in clear gelatin capsules (700 mg per capsule)
Arm B 100% purified sap resin from Eucalyptus tereticornis in clear gelatin capsules (700 mg per capsule)
Arm C 100% purified sap resin from Corymbia nesophilia in clear gelatin capsules (700 mg per capsule)
Arm D 100% purified sap resin from Corymbia polycarpa in clear gelatin capsules (700 mg per capsule)
Arm E 100% purified sap resin from Corymbia bleeseri in clear gelatin capsules (700 mg per capsule)

Compliance will be measured by count of returned capsules at end of study

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

microcrystalline cellulose in clear gelatin capsules (570 mg)
Oral self-administration of 1 capsule 3 times per day for 14 days.

Control group

Placebo

Outcomes

Primary outcome [1]

Changes in blood chemistry (electrolytes, liver function, kidney function, red/white cell parameters) assessed through analysis of full blood count

Timepoint [1]

Baseline and day 14 post intervention commencement

Secondary outcome [1]

Gastrointestinal tolerance assessed using a gastrointestinal symptom questionnaire described in Holscher et al (1).

[1] H.D. Holscher, J.L. Doligale, L.L. Bauer, V. Gourineni, C.L. Pelkman, G.C. Fahey, K.S. Swanson, Gastrointestinal tolerance and utilization of agave inulin by healthy adults, Food & Function 5(6) (2014) 1142-1149.

Timepoint [1]

Baseline, day 7 and day 14 post intervention commencement

Secondary outcome [2]

Safety will be assessed by the incidence of adverse events, including but not limited to headache assessed by self-report, nausea assessed by self-report and change in stool characteristics assessed by comparison of stool types on Bristol stool scale. Participants will self-report using a daily study diary and will be questioned about potential adverse events during phone check-ins throughout the study.

Timepoint [2]

Baseline, day 7 and day 14 post intervention commencement

Secondary outcome [3]

Change in stool consistency and frequency assessed through daily monitoring of stools using the Bristol Stool Chart. Participants will self-report using a daily study diary.

Timepoint [3]

Baseline, day 7 and day 14 post intervention commencement

Eligibility

Key inclusion criteria

- Healthy male and female adults (18-65 years)
- For females of child-bearing potential – must be currently using (for at least 4 weeks) hormonal contraception for duration of trial and 4-weeks post-trial
- Any prescription medication use by participants must be stable for four weeks or more prior to trial entry

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Pregnant, planning pregnancy or breastfeeding
- Taking warfarin or any other anti-coagulant medication
- Diagnosed with cancer (if active within last 5 years and excepting skin cancer)
- Currently unwell with acute infection or fever or having Covid-19 within the last 4 weeks
- Clinically assessed abnormal laboratory values (biochemical parameters) at baseline testing.
- In poor general health as assessed by Study Investigators

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 concealment will be achieved by consecutive distribution of pre-randomised numbered study medication containers.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised 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

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Safety

Statistical methods / analysis

Thirty-six (36) participants will be recruited for this trial over five active treatment groups plus one placebo. Although there are five individual active treatment groups, the treatments are all practically identical, with only very minor variation in chemical composition. The individual treatment groups of six per group was considered enough to demonstrate initial safety of each treatment without over-exposure, and has been used in other first-in-man drug studies.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/04/2023

Actual

17/04/2023

Date of last participant enrolment

Anticipated

Actual

19/04/2024

Date of last data collection

Anticipated

Actual

10/05/2024

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,TAS,WA,VIC

Recruitment postcode(s) [1]

5063 - Eastwood

Recruitment postcode(s) [2]

2088 - Mosman

Recruitment postcode(s) [3]

3350 - Ballarat

Recruitment postcode(s) [4]

4121 - Holland Park West

Recruitment postcode(s) [5]

7250 - Launceston

Recruitment postcode(s) [6]

6285 - Margaret River

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Integria Healthcare (Australia) Pty Ltd.

Address [1]

Building 5, Freeway Office Park, 2728 Logan rd, Eight Mile Plains, QLD, 4113

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Integria Healthcare (Australia) Pty Ltd.

Address

Building 5, Freeway Office Park, 2728 Logan rd, Eight Mile Plains, QLD, 4113

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

Ethics committee address [1]

11 Burwood Rd, Hawthorn VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/01/2023

Approval date [1]

28/03/2023

Ethics approval number [1]

0119E_2023

Summary

Brief summary

This study aims to determine safety and gastrointestinal tolerance of a novel ingredient for internal use up to a period of 14 days. 

This project is testing the safety of a traditional Australian Indigenous ingredient in a modern context. The sap resin produced by several species of eucalypts (gum trees) has an extensive history of oral use, however, the safety aspects have never been investigated.  The purpose of this study is to demonstrate safety of a selection of sap resins taken from a range of different Eucalypt species (both Eucalyptus and Corymbia), in a modern context, at a standardised dose. The dosage form (in capsules) is not in accordance with traditional use (dissolved in water) and the ingredient has not been tested in this form before. 

The evidence of therapeutic internal use of this ingredient details a primary use of sap resin for digestive complaints. The potent astringent properties and ability to stem the secretion of body fluids have been detailed as the primary action for its effectiveness as a remedy for upset stomachs, diarrhoea and dysentery. The duration of use in the historical literature is not described, and it is expected, due to the primary use of this ingredient, to have been limited to short-term use, perhaps a few days to a week. Given the potential modern-day use of a mucilaginous astringent may extend to conditions such as diarrhoea predominant irritable bowel syndrome, the safe use of the ingredient for a period up to two weeks was chosen to be evaluated.

The potential benefit of this research is to demonstrate the safe use of this ingredient internally at a standardised dose over a two-week period.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Elizabeth Steels

Address

Registered Office: 188 James Street, New Farm, 4005 QLD

Country

Australia

Phone

+61 428983280

Fax

elizabeth.steels@integria.com

Contact person for public queries

Name

Elizabeth Steels

Address

Registered Office: 188 James Street, New Farm, 4005 QLD

Country

Australia

Phone

+61 428983280

Fax

elizabeth.steels@integria.com

Contact person for scientific queries

Name

Elizabeth Steels

Address

Registered Office: 188 James Street, New Farm, 4005 QLD

Country

Australia

Phone

+61 428983280

Fax

elizabeth.steels@integria.com

Data sharing statement

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

No/undecided IPD sharing reason/comment

The study is commercial-in-confidence

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.

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