Skip to content

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000280606
Enrollment
42
Registered
2023-03-15
Start date
2023-04-17
Completion date
2024-04-19
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 fro

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

Sponsors

Integria Healthcare (Australia) Pty Ltd.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026