CompletedPhase 1ACTRN12623000280606

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


Sponsor

Integria Healthcare (Australia) Pty Ltd.

Enrollment

36 participants

Start Date

Apr 17, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria3

  • 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 Criteria6

  • 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

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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 Eucalypt

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


Locations(1)

NSW,QLD,TAS,WA,VIC, Australia

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ACTRN12623000280606