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IRCT20230318057752N1 IRCT 2023-04-11 Fasa University of Medical Sciences Effect of Ocimum basilicum in anxiety The comparison of the efficacy of hydroalcoholic extract of Ocimum basilicum and placebo in treatment of anxiety in depressed patients: A randomized double-blind clinical trial 2023-04-24 anticipated 60 Complete https://irct.ir/trial/69230 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization of participants is based on limited randomization, in which case the number of people in each group will be equal. For this purpose, we will remove 30 white balls and 30 black balls that represent each of the studied groups from the bag without replacement and write down their order. Then we put opaque and sealed envelopes containing black or white coded questionnaires into a box in the same order as the balls are removed. This box will be placed in the place where the researcher is visiting the patients participating in the study, and after the patient enters the study, the envelopes will be delivered to the patients in the same order of placement. After receiving the envelope, people will complete the questionnaires in another room. Medicines and placebos are placed in boxes with the same appearance and sealed in another room and are delivered to them according to the white or black code recorded in the patient's questionnaire. None of the people present in the study will be involved in the randomization and the type of medicine received by the patient. Each part of the study, such as randomization, observation of the color code of the questionnaires, and drug delivery, will be done by someone outside the study, Blinding description: After the visit of the patients by the psychiatrist, closed transparent envelopes containing the questionnaires will be given to the patients who wish to participate in the study. In another room, the patient will complete the questionnaires inside the envelopes, which have predetermined numbers. The colleague in the room gives the patient a box with the same code as the questionnaire, which contains medicine or placebo. With this method, the researchers will be unaware of the drug or placebo. Due to the similarity between the drug and the placebo, the patient will not know the difference between them. None of the people present in the study will be involved in the randomization and the type of medicine received by the patient. 2-3 Depression, anxiety. Intervention 1: Intervention group: For four weeks, he consumes one tablespoon of Ocimum basilicum hydroalcoholic extract syrup at a dose of 220 mg/ml every night. This syrup will be produced by the order of Fasa University of Medical Sciences in the Faculty of Pharmacy of Shiraz University of Medical Sciences. Intervention 2: Control group: For four weeks, he consumes a tablespoon of placebo syrup every night, which has the same shape and packaging as Ocimum basilicum syrup. In order to prepare placebo simple syrup according to the American Pharmacopoeia, 85 grams of sugar is mixed with 100 ml of distilled water (similar to the base of medicinal syrup) and mixed slowly at a temperature of 100 degrees until it becomes uniform and with the help of permitted food coloring It should be the same color as medicinal syrup. Yes - There is a plan to make this available What will be shared: Demographic information and clinical trial results When: 6 months after the publication of the article, it will be possible to access the data. To whom: Researchers in all universities of medical sciences Conditions: The applicant should submit her request to the Vice-Chancellor of Research and Technology of Fasa University of Medical Sciences, and if this vice-chancellor and the ethics committee of this university agree, the data will be provided to applicant . Where to obtain: Fasa University of Medical Sciences, Vice President of Research and Technology How to obtain: Approval of the Research and Technology Vice-Chancellor and Ethics Committee of Fasa University of Medical Sciences Comments:
public Kiarash Zare
Ibn Sina square, Fasa
Fasa Iran (Islamic Republic of) ۷۴۶۱۶۸۶۶۸۸ +98 71 5335 0994 kiarashzare1998@yahoo.com Fasa University of Medical Sciences scientific Dr. Seyed Amin Kouhpayeh
Ibn Sina square, Fasa
Fasa Iran (Islamic Republic of) ۷۴۶۱۶۸۶۶۸۸ 0715335099 kouhpayeha@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) Men and women between 18 and 65 years old People with major depressive disorder based on DSM 5 criteria Obtaining a minimum score of 18 in the Hamilton Anxiety Questionnaire Not taking any new anti-anxiety medication in the last 1 month Not suffering from significant internal diseases such as heart and lung failure, cancer, vascular disease, rheumatological disease, history of seizures and hypothyroidism, etc. Not using anticoagulant or anti-platelet drugs such as warfarin, heparin, aspirin, etc. No drug and alcohol addiction 18 years 65 years Both Any allergy to Ocimum basilicum and its products Pregnancy or breastfeeding Hypersensitivity to specific serotonin re-uptake inhibitor drugs Patients who will not have proper follow-up F32 Major depressive disorder, single episode Treatment - Drugs Placebo Intervention group: For four weeks, he consumes one tablespoon of Ocimum basilicum hydroalcoholic extract syrup at a dose of 220 mg/ml every night. This syrup will be produced by the order of Fasa University of Medical Sciences in the Faculty of Pharmacy of Shiraz University of Medical Sciences. Control group: For four weeks, he consumes a tablespoon of placebo syrup every night, which has the same shape and packaging as Ocimum basilicum syrup. In order to prepare placebo simple syrup according to the American Pharmacopoeia, 85 grams of sugar is mixed with 100 ml of distilled water (similar to the base of medicinal syrup) and mixed slowly at a temperature of 100 degrees until it becomes uniform and with the help of permitted food coloring It should be the same color as medicinal syrup. Depression score in Beck questionnaire. Timepoint: Before starting the study and 4 weeks after taking the drug. Method of measurement: Based on the Beck Depression Questionnaire. Anxiety score in Hamilton questionnaire. Timepoint: Before starting the study and 4 weeks after taking the drug. Method of measurement: Based on Hamilton anxiety questionnaire. Fasa University of Medical Sciences Approved 2023-03-15 Ethics committee of Fasa University of Medical Sciences Ibn Sina square, Fasa Fasa Fars Iran (Islamic Republic of)