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IRCT20190406043175N9 IRCT 2023-07-09 Mashhad University of Medical Sciences The effect of red cabbage on insomnia Evaluation of the possible hypnotic impact of Brassica oleracea product in patients with insomnia 2023-09-23 anticipated 86 Recruiting https://irct.ir/trial/71154 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The numbers from 1 to 86 are written on 86 papers and placed inside a bag. Even numbers are for intervention group and odd numbers are for control group. Each time a patient enters the study according to entry criteria, a paper is removed from the bag and the number written on the paper is the base of entering to each group, Blinding description: Healthcare personnel, data collection authorities and those who evaluate the outcome are completely uninformed about the recipient groups. It should be noted that the patient is aware of the clinical trial but does not know whether he is taking the placebo or the main drug. 1-2 Insomnia. Intervention 1: Control group: Receiving the same form of capsule prepared from red cobbage extract with starch powder without red cobbage in the unique shapes for all groups. It is noteworthy that these capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 4 weeks. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug. Intervention 2: Intervention group: Receiving the capsule prepared from red cobbage extract with starch powder in form of unique shapes for all groups. These capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 4 weeks. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fatemeh Forouzanfar
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2538 forouzanfarf@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Forouzanfar
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2538 forouzanfarf@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Non-pregnant men and women 18 years or older Sleeping problem in recent weeks No history of allergic reactions to red cabbage or its derivatives Having enough literacy to read and understand the questionnaire and answer the questions alone 18 years 60 years Both History of any mental disorder History of serious cardiovascular, liver, kidney or other systemic diseases History of addiction or smoking History of abnormal thyroid function tests History of taking anti-depressant or anti-psychotic drugs two weeks before entering the study Occurrence of allergic reactions to the capsules and their contents during the study period G47.0 Insomnia Treatment - Drugs Treatment - Drugs Control group: Receiving the same form of capsule prepared from red cobbage extract with starch powder without red cobbage in the unique shapes for all groups. It is noteworthy that these capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 4 weeks. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug. Intervention group: Receiving the capsule prepared from red cobbage extract with starch powder in form of unique shapes for all groups. These capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 4 weeks. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug. Change of score in the Pittsburgh questionnaire. Timepoint: Before the start of the study and at the end of the study. Method of measurement: Based on the Pittsburgh Questionnaire. Mashhad University of Medical Sciences Approved 2022-12-20 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)