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The Efficacy of a Herbal Supplement in the Prevention of PTSD (PHYTéS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03724448
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Riadh Boukef, Hôpital Universitaire Sahloul

Brief 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. 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.


Condition or disease Intervention/treatment Phase
PTSD, Post Traumatic Stress Disorder Diagnosis, Psychiatric Follow up Drug: aleozen Drug: Placebo Oral Tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Efficacy of a Herbal Supplement in the Prevention of Treatment of Post-traumatic Stress Disorder Versus Placebo (PHYTéS Study)
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALEOZEN group
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
treatment with herbal medicine

Placebo Comparator: placebo group
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
No aleozen treatment




Primary Outcome Measures :
  1. 50% diminution or stabilization of CAPS score after 3 and 6 months [ Time Frame: after 3 and 6 months of patient's inclusion ]
    50% diminution or stabilization of CAPS score



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724448


Locations
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Tunisia
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
Sponsors and Collaborators
Hôpital Universitaire Sahloul

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Responsible Party: Riadh Boukef, Professor, Hôpital Universitaire Sahloul
ClinicalTrials.gov Identifier: NCT03724448    
Other Study ID Numbers: HUSahloul
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: researchers will participate in the recruitment of patients with post traumatic syndrom

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Mental Disorders
Trauma and Stressor Related Disorders