Trial Review

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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
Date results information initially provided
25/06/2024
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] 309155 0
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 329276 0
Condition category
Condition code
Alternative and Complementary Medicine 326227 326227 0 0
Herbal remedies
Oral and Gastrointestinal 326230 326230 0 0
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] 325606 0
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] 334099 0
Changes in blood chemistry (electrolytes, liver function, kidney function, red/white cell parameters) assessed through analysis of full blood count
Timepoint [1] 334099 0
Baseline and day 14 post intervention commencement
Secondary outcome [1] 419332 0
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] 419332 0
Baseline, day 7 and day 14 post intervention commencement
Secondary outcome [2] 419333 0
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] 419333 0
Baseline, day 7 and day 14 post intervention commencement
Secondary outcome [3] 419472 0
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] 419472 0
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
36
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Recruitment postcode(s) [1] 39754 0
2088 - Mosman
Recruitment postcode(s) [2] 39755 0
3350 - Ballarat
Recruitment postcode(s) [3] 39756 0
4121 - Holland Park West
Recruitment postcode(s) [4] 39753 0
5063 - Eastwood
Recruitment postcode(s) [5] 39758 0
6285 - Margaret River
Recruitment postcode(s) [6] 39757 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 313355 0
Commercial sector/Industry
Name [1] 313355 0
Integria Healthcare (Australia) Pty Ltd.
Country [1] 313355 0
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] 315107 0
None
Name [1] 315107 0
Address [1] 315107 0
Country [1] 315107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312577 0
National Institute of Integrative Medicine
Ethics committee address [1] 312577 0
11 Burwood Rd, Hawthorn VIC 3122
Ethics committee country [1] 312577 0
Australia
Date submitted for ethics approval [1] 312577 0
17/01/2023
Approval date [1] 312577 0
28/03/2023
Ethics approval number [1] 312577 0
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 125154 0
Dr Elizabeth Steels
Address 125154 0
Registered Office: 188 James Street, New Farm, 4005 QLD
Country 125154 0
Australia
Phone 125154 0
+61 428983280
Fax 125154 0
Email 125154 0
elizabeth.steels@integria.com
Contact person for public queries
Name 125155 0
Dr Elizabeth Steels
Address 125155 0
Registered Office: 188 James Street, New Farm, 4005 QLD
Country 125155 0
Australia
Phone 125155 0
+61 428983280
Fax 125155 0
Email 125155 0
elizabeth.steels@integria.com
Contact person for scientific queries
Name 125156 0
Dr Elizabeth Steels
Address 125156 0
Registered Office: 188 James Street, New Farm, 4005 QLD
Country 125156 0
Australia
Phone 125156 0
+61 428983280
Fax 125156 0
Email 125156 0
elizabeth.steels@integria.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.