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IRCT20210926052594N1 IRCT 2021-10-09 Shahre-kord University of Medical Sciences Citrus Aurantium and anxiety in the last month of pregnancy Investigating the effect of Citrus Aurantium blossom on anxiety in the last month of pregnancy and reducing postpartum depression 2021-10-12 anticipated 100 Complete https://irct.ir/trial/59048 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the “generate numbers” section of the randomizer.org website, 100 numbers will be generated from 1000 to 100000 for the participants’ list, and even and odd numbers will be assigned to either the intervention or control groups, Blinding description: Participants will be kept blinded to which treatment they are receiving. Investigators and staff will be kept blind to participant assignment. Procedures will be implemented to maintain separation between staff members that take outcome measurements and staff to deliver the intervention. Staff who obtain outcome measurement will not be informed of the group assignment. Investigation staff who will deliver the intervention will not take outcome measurements. 3 Anxiety. Intervention 1: Intervention group: 500mg Citrus aurantium capsules taken orally BID for 6 weeks (from the 36th week of pregnancy to 2 weeks postpartum). Intervention 2: Control group: placebo capsules (starch) taken orally BID for 6 weeks (from the 36th week of pregnancy to 2 weeks postpartum). Yes - There is a plan to make this available What will be shared: All collected deidentified IPD will be shared. When: Data files will be available starting 6 months after publishing the results. To whom: Available for people working in academic institutions Conditions: No specific criteria Where to obtain: Requests will be received at ramila.nour@gmail.com How to obtain: Requests will be reviewed by our correspondent and the requesters will be notified shortly. Comments:
public Fateme Ahmadinia
No. 38, Danesh St., Najafabad
Najafabad Iran (Islamic Republic of) 8513743973 +98 938 793 2492 Fateme.ahmadiniaa@gmail.com Shahre-kord University of Medical Sciences scientific Fateme Ahmadinia
No. 38, Danesh St., Najafabad
Najafabad Iran (Islamic Republic of) 8513743973 +98 938 793 2492 Fateme.ahmadiniaa@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Having informed consent Being literate Being over 36 weeks pregnant Low-risk pregnancy 18 years 35 years Female History of allergy to herbal medicines History of chronic disease Addiction or drug abuse F06.4 Anxiety disorder due to known physiological condition Treatment - Drugs Placebo Intervention group: 500mg Citrus aurantium capsules taken orally BID for 6 weeks (from the 36th week of pregnancy to 2 weeks postpartum) Control group: placebo capsules (starch) taken orally BID for 6 weeks (from the 36th week of pregnancy to 2 weeks postpartum) Beck anxiety score. Timepoint: Baseline, immediately after delivery, 2 weeks postpartum. Method of measurement: Beck Anxiety Inventory. Shahre-kord University of Medical Sciences Approved 2021-04-06 Ethics committee of Shahrekord University of Medical Sciences Shahrekord University of Medical Sciences, Rahmatie, Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)