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IRCT20131009014957N13 IRCT 2022-04-27 Tabriz University of Medical Sciences The effect of oral lavender essential oil on menopausal symptoms, serum lipid profile, and cortisol concentration in postmenopausal women The effect of oral lavender essential oil on menopausal symptoms, serum lipid profile, and cortisol concentration in postmenopausal women: A triple-blind, randomized, controlled trial 2022-05-10 anticipated 72 Complete https://irct.ir/trial/62232 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible women will be assigned into two groups of Lavender gelatin capsule or placebo using a randomized blocking method with the 4 and 6-sized blocks and a 1: 1 allocation ratio. The allocation sequence will be generated by the researcher through RAS (Random Allocation Software). The medicines and placebo will be placed in a container. Containers will be assigned numbers from 1 to 72. They will be the same shape, closed, opaque, and contain 60 capsules, and their preparation will be done based on the sequence allocation by the person not involved in the research, Blinding description: The first group will receive one Lavender essential oil 80 mg capsule daily, and the second group will receive a placebo capsule that will be the same shape, color, and weight. participants, the principal investigator, health care personnel, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded. 3 Menopausal symptoms. Intervention 1: Intervention group: Recipient of gelatin capsules containing 80 mg of lavender essential oil. The course of drug consumption is 60 days and one capsule is consumed daily after a meal, which is prepared in 30-number packages by Barij Essential Oil Company and will be delivered to the participants in two periods. Intervention 2: Control group: Recipient of placebo in the form of a gelatin capsule that is very similar in color and weight to a lavender gelatin capsule and will be made by Barij Essential Oil Company, except that it will have no effective substance. The placebo will be given to participants with the same instructions as Lavender Gelatin Capsules. Yes - There is a plan to make this available What will be shared: Data on the main outcome will be published When: Six months after printing the results To whom: Researchers at institutions have access to data Conditions: In order to help scientific progress in the field of research Where to obtain: farshbafa@tbzmed.ac.ir Dr. Azizeh Farshbaf Khalili How to obtain: Scientific approval of the applicant by Tabriz University of Medical Sciences Comments:
public Dr. Azizeh Farshbaf-Khalili
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 1928 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Azizeh Farshbaf-Khalili
Physical Medicine and Rehabilitation Research Center Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3337 1134 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Be literate enough to fill out a questionnaire or presence of a literate person in the family Having a normal menopause Women who were menopause less than 6 years ago Having a minimum of 45 and a maximum of 60 years of age Earning a minimum score of 15 and a maximum of 42 in the Green assessment 45 years 60 years Female Use of tobacco and alcoholic beverages and herbal medicines Existence of stressors such as the death of first-degree relatives in the last 6 months and job loss Existence of malignant disease Recent history of surgery and trauma Lavender consumption during the 3 months before the study Use of hormone therapy during the past 6 months Having known physical and mental illnesses according to self-expression (depression, uncontrolled diabetes, cardiovascular diseases) N95 Menopausal and other perimenopausal disorders Treatment - Drugs Placebo Intervention group: Recipient of gelatin capsules containing 80 mg of lavender essential oil. The course of drug consumption is 60 days and one capsule is consumed daily after a meal, which is prepared in 30-number packages by Barij Essential Oil Company and will be delivered to the participants in two periods. Control group: Recipient of placebo in the form of a gelatin capsule that is very similar in color and weight to a lavender gelatin capsule and will be made by Barij Essential Oil Company, except that it will have no effective substance. The placebo will be given to participants with the same instructions as Lavender Gelatin Capsules. Green scale symptoms score in postmenopausal women. Timepoint: Before and after intervention. Method of measurement: Green questionnaire. Serum cortisol levels. Timepoint: Before and after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method by ELISA kits. Reported possible side effects. Timepoint: After the intervention. Method of measurement: Checklist of possible side effects. The level of satisfaction with the intervention received. Timepoint: After the intervention. Method of measurement: Satisfaction checklist received from the intervention. Serum levels of lipid profile. Timepoint: Before and after intervention. Method of measurement: By spectrophotometric method with device with Alcyon 300 model and Pars test kit. Tabriz University of Medical Sciences Approved 2022-02-15 The Ethics Committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology, Floor 3, No 2 Central Building, Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)