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IRCT20200104046001N1 IRCT 2020-01-10 Mashhad University of Medical Sciences Effect of Ocimum basilicum on sleep quality in menopausal women The effect of oral capsule of Ocimum basilicum leaf extract on sleep quality in menopausal women 2020-02-09 anticipated 60 Complete https://irct.ir/trial/44812 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Originally from Mashhad 5 and Samen districts, their names are written on paper. Two centers are selected by lot and each center has two centers that meet the conditions of staff cooperation and presence of postmenopausal women. After attending these centers, the menopausal women are selected after being given access to the research unit selection checklist, followed by oral capsules of basil leaf extract and placebo, administered by a pharmacy consultant professor at the Medicinal Plant Pharmacology Center of Mashhad University of Medical Sciences, Mashhad, Iran. The packaging is completely identical and only a drug consultant is aware of it will be provided with the researcher based on the code and Individuals with inclusion criteria who fall into groups according to the random number table, Blinding description: In order to blind the basil leaf extract and placebo capsule to the researcher in similar forms and in identical cans, each researcher has a code that the pharmacy consulting professor is aware of. Individuals with inclusion criteria are randomly assigned to the groups using the random number table, so by the end of the study unit, the researcher and the statistical analyst will not know the codes for the basil leaf extract and placebo. 3 sleep disorder. Intervention 1: Intervention group: Intervention group: Oral Extract of Ocimum Basilicum Leaf Extract Made in the Pharmacology Department of Mashhad University of Medical Sciences, each capsule contains 500 mg of Basil Leaf Extract.research units consume one capsule daily before bedtime for one month. Intervention 2: Control group: Control group: Use placebo with similar capsules and cans that Made in the Pharmacology Department of Mashhad University of Medical Sciences, each capsule contains 500 mg of Starch.research units consume one capsule daily before bedtime for one month. 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 No more information
public حمیده حسینی
School of Nursing and Midwifery ,Doktota Crossroads, ,DaneshgahStreet,
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 hoseinih971@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh zahra karimi
School of Nursing and Midwifery,Doktora Crossroads, Daneshgah Street,
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Karimifz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) At least literacy Being a postmenopausal patient(Have at least 12 months spontaneous abstinence, with no association with pregnancy, lactation, or other medical, pharmaceutical, or serum FSH levels> 40IU / L.) Having a sleep quality score above 5 Age 40 to 65 years No history of sleep disorder requiring medical intervention (according to the person) Lack of allergy to Ocimum basilicum 40 years 65 years Female Smoking and alcohol Hormone therapy in the past 6 months Having severe depression, stress, or severe anxiety(A score of less than 19 under the stress scale, a score of less than 10 under the anxiety scale, or a score of less than 14 under the DASS-21 Depression Scale) Medical illness(Such as, asthma, restless leg syndrome, kidney failure, liver disease,, chronic illness, seizure, Parkinson's disease, epilepsy, arthritis) Mental illness(Delirium, Schizophrenia, Alzheimer's) Infectious and feverish diseases(Respiratory tract infection, urinary and hepatitis, influenza, arthritis) Use herbal sleep medicines that affect sleep(Lavender, Spring Orange, Basil Lemon, herbal tea of Ocimum basilicum) Concomitant use of sleep-inducing chemical drugs(Clonidine, antidepressants, tamoxifen, raloxifene, anticonvulsants such as gabapentin, sedative) Use of anti-coagulants, anxiolytic drugs Having a night shift G47 Sleep disorders Treatment - Other Placebo Intervention group: Intervention group: Oral Extract of Ocimum Basilicum Leaf Extract Made in the Pharmacology Department of Mashhad University of Medical Sciences, each capsule contains 500 mg of Basil Leaf Extract.research units consume one capsule daily before bedtime for one month Control group: Control group: Use placebo with similar capsules and cans that Made in the Pharmacology Department of Mashhad University of Medical Sciences, each capsule contains 500 mg of Starch.research units consume one capsule daily before bedtime for one month Sleep quality. Timepoint: Before the study and immediately after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Mashhad University of Medical Sciences Approved 2019-11-12 Ethics Committee of Mashhad University of Medical Sciences-School of Nursing and Midwifery School of Nursing and Midwifery,Doctora Crossroads,Daneshgah Street, Mashhad Razavi Khorasan Iran (Islamic Republic of)