NCT03904511

Safety, Tolerability and Behavioural Effects of Souroubea-Platanus in Healthy Volunteers

Completed Phase 1 Last updated 11 February 2020

What this trial tests

Phase 1 trial testing Souroubea-Platanus Preparation in Anxiety in 45 participants. Completed in 1 February 2020.

Timeline

15 May 2019

Primary endpoint
31 December 2019

1 February 2020

Quick facts

Lead sponsor	University of Ottawa
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	15 May 2019
Primary completion	31 December 2019
Estimated completion	1 February 2020
Sites	1 location across Canada

Drugs / interventions tested

• Souroubea-Platanus Preparation
• Placebo

Conditions studied

• Anxiety — all drugs for Anxiety →
• Stress, Psychological — all drugs for Stress, Psychological →

Sponsor

University of Ottawa

Who can join

18 and older, any sex, with Anxiety or Stress, Psychological. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Souroubea sympetala extracts have shown anxiolytic properties in animal models. Souroubea and its active principle betulinic acid appear to exert these effects by acting as an agonist for the benzodiazepine (BZD) binding site of the GABAA receptor with no withdrawal effects on food intake, locomotor activity, or other symptoms typically associated with BZD agonism. As such, this may offer a valuable source for an alternative anti-anxiety treatment.

The primary objective of this study is to (1) to evaluate the safety and tolerability of a single daily dose of an extract of a mixture of Souroubea spp. leaf and small branch material and Platanus spp. bark when administered orally over two weeks in healthy volunteers. Based on its safety in canine trials, we hypothesize that Souroubea-Platanus (SP) preparation will be well tolerated with adverse event profile similar to placebo.

The secondary objective is (2) to establish whether some of the anxiolytic properties of Souroubea-platanus seen in animal models will translate to human participants. We hypothesize that Souroubea-Platanus preparation will demonstrate anxiolytic and/or stress-reduction properties as indicated by salivary cortisol levels and self-report measures of anxiety.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in Deubiquitinating Enzyme Inhibition and Applications in Cancer Therapeutics.
   Antao AM, Tyagi A, Kim KS, Ramakrishna S. · · 2020 · cited 126× · PMID 32549302 · DOI 10.3390/cancers12061579
2. Substances of Natural Origin in Medicine: Plants vs. Cancer.
   Gielecińska A, Kciuk M, Mujwar S, Celik I, et al · · 2023 · cited 39× · PMID 37048059 · DOI 10.3390/cells12070986
3. Vesicular Carriers for Phytochemical Delivery: A Comprehensive Review of Techniques and Applications.
   Jacob S, Kather FS, Boddu SHS, Rao R, et al · · 2025 · cited 8× · PMID 40284459 · DOI 10.3390/pharmaceutics17040464
4. Pharmacokinetic Characterization and Bioavailability Barrier for the Key Active Components of Botanical Drug Antitumor B (ATB) in Mice for Chemoprevention of Oral Cancer.
   Bui D, Yin T, Duan S, Wei B, et al · · 2021 · cited 4× · PMID 34463097 · DOI 10.1021/acs.jnatprod.1c00501