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IRCT20180603039967N1 IRCT 2018-11-04 Shiraz University of Medical Sciences The effect of basil extract in insomnia . The comparison of the efficacy of hydroalcoholic extract of ocimum basilicum and placebo in treatment of insomnia in depressed patients who are referred to psychiatry clinic of Hafez hospital in Shiraz (a randomized double blind clinical trial) 2018-10-31 anticipated 60 Complete https://irct.ir/trial/34495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to equalize the number of the members of the groups, the restricted randomization and random allocation rule will be used . in random allocation rule , classically 2 different color balls in equal numbers will be throwed in a bag and the order of removal of the balls will be recorded . participants will get in two groups by the same order (Of course this process will be done by randomization saftwares and the code 1 and code 2 will be recorded instead of colors.) .Beacause the patients visit the doctor in a few days of a week and also a few number of the patients will fill the including criteria , the sampling needs several days to complete . so sampling would be done via simple intermittent method and it starts with adding the first patient and finishes when the number of patients achives the study goal . 60 not transparent sealed envelopes with same external appearance will be prepared in two 30 people groups as indicator of the participants . Each envelope consists of questonnaires with the code1 or 2. Based on the order of random allocation achived in previous step, the envelopes are placed in a box in the office. The researcher who is visiting the patients, gives them the envelopes based on the order .After recieving the envelopes, the patients will open the envelope and fill the questionnaire in a seperate room. The drug and the placebo are in seperate boxes with same appearance. Each patient recieves a box based on the code of the questionnaires ( code1 or code2). It should be noted that none of the researchers of this study are involved in random allocation and aware of the boxes that patients recieve. All the steps, including random allocation, seeing the code of the questionnaire, and giving the drug to the patients is done by a coworker out of the study , Blinding description: After the patient was visited by the physician, a not transparent and sealed envelope containing the questionnaire and the code 1 or 2 will be given to the patient . The patient will open the envelope in a separate room and will answer the questionnaires. Queationnaires have a specific code and it would be seen by a coworker in that room and a box with the same code which may contain drug or placebo would be delivered to the patient. None of the researchers are aware of the code of the envelopes and questionnaires. As a result reserchers are not aware of the source of the medications the patients are recieving. Also the patients can not differentite between placebo and the drug due to same appearance and taste. It should be noted that none of the researchers of this study would be involved in random allocation and aware of the boxes that patients recieve. All the steps, including random allocation, seeing the code of the questionnaire, and giving the drug box to the patients is done by a coworker out of the study . 2-3 Major deprassion + Insomnia. Intervention 1: Intervention group: Ocimum basilicum will be dried and hydroalcoholic extract will be prepared. Capsules will be filled with hydroalcoholic extract powder . The patients will recieve 1100 mg of extract 1 hour before sleep each night. The patients will recieve the capsules for 4 weeks. The extract is made in school of pharmacy of SUMS. Intervention 2: Control group: Placebo with same appearance will be prepared for control group. Capsules will be filled with starch . Yes - There is a plan to make this available What will be shared: All deidentified individual participant data collected in this study will be available for other researchers When: 1 year after publishing the results of study To whom: The data will be available for all researchers Conditions: The data are available for all researchers who want to improve the human life quality Where to obtain: Dr Mohammadreza Nazari 00989107001457 mohammad1992nn@gmail.com How to obtain: By a phone call or leaving a messeage and after informing my colleagues I will send you the scanned files Comments:
public Mohammadreza Nazari
Alavi dormitory, No 2 Alley, Mollasadra Ave, Namazi Square
Shiraz Iran (Islamic Republic of) 7193613565 +98 71 3212 2464 culture@sums.ac.ir Shiraz University of Medical Sciences scientific Seyed Hamdollah Mosavat
Iranian traditional medicine group, Shiraz college of medicine , Zand Blvd,
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3234 5145 hamdi_88114@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The patients betwwen 18 to 65 years old suffering from major deppresion Getting at least the score 12 out of 28 of the insomnia severity index questionnaire 18 years 65 years Both Taking any sedative medication in last month Sufferng from significant medical diseases like cardiopulmonary failure, cancer, vascular disease, rheumatologic diseases, history of seizure, thyroid disease, ... Taking anticoagulant or antiplatelet medications like warfarin, aspirin ,... Opioid and alcohol addiction Pregnancy and lactation G47.0 Insomnia Treatment - Drugs Placebo Intervention group: Ocimum basilicum will be dried and hydroalcoholic extract will be prepared. Capsules will be filled with hydroalcoholic extract powder . The patients will recieve 1100 mg of extract 1 hour before sleep each night. The patients will recieve the capsules for 4 weeks. The extract is made in school of pharmacy of SUMS. Control group: Placebo with same appearance will be prepared for control group. Capsules will be filled with starch . Beck depression inventory score /Insomnia Severity Index score (ISI) / Pittsburgh Sleep Quality Index score(PSQI). Timepoint: Filling the questionnaires before starting the intervention and 4 week after taking drug. Method of measurement: Beck depression inventory /Insomnia Severity Index (ISI) / Pittsburgh Sleep Quality Index (PSQI). Shiraz University of Medical Sciences Approved 2018-08-19 Ethics committee of Shiraz University of Medical Sciences Shiraz Univercity of Medical Sciences central buildingŲŒ Zand Blvd Shiraz Fars Iran (Islamic Republic of)