NCT03724448 (PHYTéS) is a Phase 1 clinical trial of aleozen in PTSD, Post Traumatic Stress Disorder, sponsored by Hôpital Universitaire Sahloul.

Who is sponsoring NCT03724448?

NCT03724448 is sponsored by Hôpital Universitaire Sahloul.

What drugs are being tested in NCT03724448?

Interventions in NCT03724448: aleozen, Placebo Oral Tablet.

What condition does NCT03724448 study?

NCT03724448 studies PTSD, Post Traumatic Stress Disorder, Diagnosis, Psychiatric, Follow up.

Is NCT03724448 still recruiting?

NCT03724448 is currently completed. Last updated 23 March 2023.

Last reviewed 2023-03-23 · How we verify

NCT03724448: PHYTéS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Efficacy of a Herbal Supplement in the Prevention of PTSD

Completed Phase 1 Last updated 23 March 2023

What this trial tests

Phase 1 trial testing aleozen in PTSD, Post Traumatic Stress Disorder in 200 participants. Completed in 1 September 2018.

Timeline

30 June 2018

Primary endpoint
1 September 2018

1 September 2018

Quick facts

Lead sponsor	Hôpital Universitaire Sahloul
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	200
Start date	30 June 2018
Primary completion	1 September 2018
Estimated completion	1 September 2018
Sites	1 location across Tunisia

Drugs / interventions tested

aleozen — full drug profile →
Placebo Oral Tablet — full drug profile →

Conditions studied

PTSD, Post Traumatic Stress Disorder — all drugs for PTSD, Post Traumatic Stress Disorder →
Diagnosis, Psychiatric — all drugs for Diagnosis, Psychiatric →
Follow up — all drugs for Follow up →

Sponsor

Hôpital Universitaire Sahloul — full company profile →

Who can join

20 and older, any sex, with PTSD, Post Traumatic Stress Disorder or Diagnosis, Psychiatric. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Psycho-traumatic disorders are a disabling condition whose epidemiological data vary according to the country but also the populations studied and the measuring instruments used. The estimated prevalence of posttraumatic stress disorder (PTSD) appeared to be increasing in recent years, and this appears to be due, among other things, to the improvement of the standardized evaluation procedure. The survey "Mental Health in General Population", conducted in metropolitan France between 1999 and 2003 on more than 36,000 people estimated its instantaneous prevalence (last month) of a full PTSD was 0.7% in the SMPG overall sample, with almost equal frequency between men (45%) and women (55%). This figure is close to that reported in a European population for the ESEMeD study. A very significant psychiatric comorbidity was found in subjects with PTSD, particularly with mood disorders, other anxiety disorders and addictive behaviors. The link with the suicidal risk was clearly established, which is the gravity of this pathology. The most important publications are made by American teams who have identified and evaluated the treatment of this pathology among veterans of the various wars led by the country.

Publications & conference data

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

Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD).
Bertolini F, Robertson L, Bisson JI, Meader N, et al · · 2022 · cited 19× · PMID 35141873 · DOI 10.1002/14651858.cd013443.pub2
Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms.
Bertolini F, Robertson L, Bisson JI, Meader N, et al · · 2024 · cited 4× · PMID 38767196 · DOI 10.1002/14651858.cd013613.pub2

Verify or expand the search:

Other recruiting trials for PTSD, Post Traumatic Stress Disorder

Currently open trials in the same condition.

NCT06394284 — Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural · Phase 3 · recruiting

Other Hôpital Universitaire Sahloul trials

Trials by the same sponsor.

NCT07329881 — Artificial Intelligence Algorithm for the Interpretation of Traumatic Bone Radiographs · active not recruiting
NCT07147699 — Evaluation of the Effectiveness of the CardioStory Device in Distinguishing Heart Failure From Other Causes in Patients · not yet recruiting
NCT07089277 — External Validation of the Glasgow-Blatchford Bleeding Score in a Tunisian Population · recruiting
NCT06953154 — Monocyte Distribution Width (MDW): An Early Marker of Sepsis in Patients With Comorbidities · completed
NCT05646433 — Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03724448 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hôpital Universitaire Sahloul
Last refreshed: 23 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03724448.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing