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)

To detemine the insomnia severity and sleep quality of the depressed patients who are referred to psychiatry clinic of Hafez hospital in 2018 after taking the Ocimum basilicum hydroalcoholic extract based on Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI).

Two arm parallel group controlled randomised trial with double blinded outcome assessment

Major depression is the most prevalent psychiatric disease. Insomnia is one of the symptoms which is contributable to risk of suicide and recurrance rate. In spite of many hypnoic drugs, many patients still suffer from insomnia and drug side effects. Iranian traditional medicine as a subgroups of Complementary and Alternative Medicine has discussed about sedative features of Ocimum basilicum as has been documented in some animal studies. The study will be performed in Hafez hospital psychiatry clinic of Shiraz University of Medical Sciences(SUMS) in Shiraz, Iran. The patients who fullfill study criterias will be devided in two 30 people groups randomisely. They will answer 3 questiannaire that record their depression and insomnia severity and sleep quality. Then they will recieve drug or placebo and after 1 month they will again answer the questionnaires. Drug and placebo have same appearance .All steps of random allocation and delivering the drug and gathering the questionnaires will be done by a coworker out of the study. So both the researchers and the participants will be blinded in this study.

Inclusion criteria: people between 18 - 65 years old who are suffering from major depression and concomitant insomnia Exclusion criteria: significant medical diseases; pregnancy; addiction

One of the groups recieves Ocimum basilicum extract and the other one recieves placebo

Insomnia severity; sleep quality; depression severity

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 .

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 .

All deidentified individual participant data collected in this study will be available for other researchers

1 year after publishing the results of study

The data will be available for all researchers

The data are available for all researchers who want to improve the human life quality

Dr Mohammadreza Nazari 00989107001457 mohammad1992nn@gmail.com

By a phone call or leaving a messeage and after informing my colleagues I will send you the scanned files