Clinical trial

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

Name
PHYTéS
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.
Trial arms
Trial start
2018-06-30
Estimated PCD
2018-09-01
Trial end
2018-09-01
Status
Completed
Phase
Early phase I
Treatment
aleozen
treatment with herbal medicine
Arms:
ALEOZEN group
Placebo Oral Tablet
No aleozen treatment
Arms:
placebo group
Size
200
Primary endpoint
50% diminution or stabilization of CAPS score after 3 and 6 months
after 3 and 6 months of patient's inclusion
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-03-23

1 organization

1 product

1 drug

5 indications

Product
aleozen
Indication
PTSD
Indication
Diagnosis
Indication
Follow-up