IntroductionThe purpose of this study was to evaluate the efficacy and safety of a herbal supplement in preventing the occurrence of PTSD MethodsIt is a randomized double blind controlled trial including patients exposed to a traumatic event meeting DSM-V Criterion A and having a Peri-traumatic Distress Inventory score and/or Peri-traumatic Dissociative Experience Questionnaire (PDEQ) and/or immediate stress score (L.Crocq score) higher than the thresholds between day 1 and day 3. Patients were randomly assigned into two groups: Patients included in the herbal supplement Group received Aleozen® for 10 days while patients in the Placebo Group received a placebo. The main outcome was to assess the efficacy through the evaluation of CAPS-5 after 03 months of follow-up. The secondary outcome was to evaluate the safety of this supplement and to assess PTSD after one year. Resultstwo hundred patients were enrolled among 03 months and then randomly assigned to receive the herbal treatment or the placebo; 100 in each group. The two groups have similar characteristics at baseline. At day 10 after inclusion, the two groups had comparable CAPS-5 scores (p=0.591).After day 90 of follow-up, 85 patients (42.5%) had PTSD, according to the CAPS-5 Scale. Developing PTSD was lower in the intervention group compared to the placebo group (38.8% versus 61.2%, respectively; p<0.001). No adverse events were noted during the study. ConclusionAn early administration of a herbal supplement may prevent the occurrence of PTSD in patients exposed to trauma and having a high risk to develop it. Clinical registration NumberIt was recorded in the ClinicalTrials.gov register ( NCT03724448) in June 26 th 2018