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

Phase 1

Completed

• Conditions: Irritable bowel syndrome - D; Alternative and Complementary Medicine - Herbal remedies; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12623000280606
• Lead Sponsor: Integria Healthcare (Australia) Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Study Completion: 2024-05-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in blood chemistry (electrolytes, liver function, kidney function, red/white cell parameters) assessed through analysis of full blood count[ Baseline and day 14 post intervention commencement]