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PTSD, Post Traumatic Stress DisorderPhase 1PHYTéSNCT03724448

The Efficacy of a Herbal Supplement in the Prevention of PTSD

A Phase 1 study testing aleozen in people with PTSD, Post Traumatic Stress Disorder and Diagnosis, Psychiatric, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
aleozen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteTunisia
Study dates
30 Jun 2018to 1 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient who has been exposed to a traumatic event that could cause an acute PTSD (accident or aggression that causes intense fear, helplessness or horror)
  • a PDI (Peri-traumatic Distress Inventory) score and / or PDEQ (Traumatic Traumatic Dissociation Experience Questionnaire - Evaluative Form)
  • and / or (Appendix 1, 2 and 3) calculated between J1 and J3 and estimated moderate or high with a score> 15.

Who cannot join

  • Any serious traumatized patient who needed treatment in intensive care.
  • Any patient with psychiatric illness or psychotropic medication prior to randomization.
  • Non-cooperating patient (unable to answer the assessment test).
  • Non consenting patient.

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • HU Sahloul, sousse, Tunisia

    Sousse, Itinéraire Ceinture Cité Sahloul, 4054

Other trials in Tunisia

About this study

Official title: Evaluation of the Efficacy of a Herbal Supplement in the Prevention of Treatment of Post-traumatic Stress Disorder Versus Placebo (PHYTéS Study)

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.

Read the detailed 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.

Barrois defines traumatic neurosis as "a group of psychological disorders that arise after a longer or shorter latency, following a very intense emotional shock".

Post-traumatic stress disorder is defined by the ICD-10 classification as a "delayed or prolonged" response to a stressful situation or event (short or long-term) that would provoke distress symptoms in anyone .

According to the American classification of the DSM-V, the diagnosis of PTSD is strictly established according to different criteria. Exposure to a traumatic event ("the person has been exposed, witnessed or confronted with an event or events that have involved death or death, or serious injury or threat to their physical integrity or 'others'), and reacting to it with a feeling of intense fear, helplessness or horror (criterion A). The event is constantly relived, manifested by at least one symptom of the repetition syndrome (criterion B) that can be repetitive and invasive memories of the event (including images, thoughts, perceptions), repetitive and painful dreams of the event, the impression or sudden acts "as if" the traumatic event recurred, an intense psychological distress when exposed to internal or external stimuli resembling an aspect of the trauma, a physiological reactivity during exposure to internal or external stimuli resembling or symbolizing an aspect of the trauma. Criterion C requires persistent avoidance of stimuli associated with trauma and blunting of general responsiveness (not present before trauma).

Criterion D refers to the impairment of cognition and mood associated with one or more traumatic events manifested by at least two symptoms, including dissociative amnesia, persistent and exaggerated negative self-perceptions of others, and world, a clear reduction of interest in important activities, a feeling of detachment and a persistent inability to feel positive emotions. There are also symptoms of neurovegetative activation, with at least two symptoms (criterion E) among sleep difficulties, irritability or anger, difficulty concentrating, hyper vigilance, startled reactions exaggerated. Criterion F concerns the duration of symptoms B, C and D which must exceed one month. The problem results in clinically significant distress or dysfunction at the social, occupational or other important operational level (criterion G). Criterion H eliminates that these symptoms are not due to the consumption of a substance (drug or alcohol) or another condition.

Despite this awareness of the functional impact of these psycho traumatic disorders, this pathology has remained under-identified both by health professionals and the general public and subsequently insufficiently treated, particularly in Tunisia. Several therapeutic protocols are proposed. The share of antidepressant treatments (yet first-line treatment in all international guidelines) is only 30% and the remaining 70% includes anxiolytics, hypnotics and herbal medicine. Several meta-analyzes have evaluated the efficacy of different families of antidepressants, but scientific research remains very poor in the field of herbal medicine.

Being tested
aleozen, Placebo Oral Tablet
Medical subject headings
Combat Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aleozenDrug

    treatment with herbal medicine

  • Placebo Oral TabletDrug

    No aleozen treatment

Study groups in NCT03724448
Study groupRoleWhat they receive
ALEOZEN groupExperimentalClinical information will be collected on a standardized card specifying general data on the patient, his antecedents, his telephone number, the circumstances of the traumatic event and the score of PDI, PDEQ and L-CROCQ, score PCL-5 to 10 days, 1 month and 6 months.
Receives: Drug: aleozen
placebo groupPlacebo comparatorClinical information will be collected on a standardized card specifying general data on the patient, his antecedents, his telephone number, the circumstances of the traumatic event and the score of PDI, PDEQ and L-CROCQ, score PCL-5 to 10 days, 1 month and 6 months.
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 50% diminution or stabilization of CAPS score after 3 and 6 months

    50% diminution or stabilization of CAPS score

    Measured: after 3 and 6 months of patient's inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2018
  2. Study start30 Jun 2018
  3. Primary completion1 Sep 2018
  4. Study completion1 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03724448
Sponsor's protocol ID
PHYTéS
Acronym
PHYTéS
Status last verified
Mar 2023
First submitted
24 Jun 2018
Last updated
23 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: researchers will participate in the recruitment of patients with post traumatic syndrom

Publications

  • Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

    PubMed 38767196
  • Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.

    PubMed 35141873

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing aleozen in people with PTSD, Post Traumatic Stress Disorder and Diagnosis, Psychiatric, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

50% diminution or stabilization of CAPS score after 3 and 6 months (time frame: after 3 and 6 months of patient's inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03724448, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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