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临床试验/NCT03724448
NCT03724448已完成1 期

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

Hôpital Universitaire Sahloul1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
200
试验地点
1
主要终点
50% diminution or stabilization of CAPS score after 3 and 6 months

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

ALEOZEN group

Experimental

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.

干预措施: aleozen (Drug)

placebo group

Placebo Comparator

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.

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

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

时间窗: after 3 and 6 months of patient's inclusion

50% diminution or stabilization of CAPS score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riadh Boukef

Professor

Hôpital Universitaire Sahloul

研究点 (1)

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