A Phase 1 interventional study of aleozen and Placebo Oral Tablet in PTSD, Post Traumatic Stress Disorder, Diagnosis, Psychiatric and Follow up, sponsored by Hôpital Universitaire Sahloul. Completed at 1 site in Tunisia. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Hôpital Universitaire Sahloul · Phase 1, Interventional, and Diagnostic
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.
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Hôpital Universitaire Sahloul is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical 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.
Drug: aleozen
Clinical 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.
Drug: Placebo Oral Tablet
treatment with herbal medicine
No aleozen treatment
50% diminution or stabilization of CAPS score after 3 and 6 months
50% diminution or stabilization of CAPS score
Time frame: after 3 and 6 months of patient's inclusion
Plan to share: No — researchers will participate in the recruitment of patients with post traumatic syndrom
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hôpital Universitaire Sahloul