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IRCT20100414003706N35 IRCT 2020-01-03 Barij Essence Pharmaceutical Company Effect of a Menohelp Barij® capsule on early symptoms of menopause Effect of a Menohelp Barij® capsule on early symptoms of menopause: a randomized placebo-controlled trial 2020-01-21 anticipated 100 Complete https://irct.ir/trial/43059 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible women will be individually allocated into intervention (Menohelp Barij®) or control (placebo) groups using stratified (based on menopause duration of less than 3 years/3 years or more) block randomization with block size of 4 and with allocation ratio of 1:1. Allocation sequence will be generated using a computer software. Sequentially numbered packages containing Menohelp Barij® or placebo will be used to conceal the allocation. Sequence generation and preparation of packages will be done by a person not involved in the participant recruitment and data collection, Blinding description: The Menohelp Barij® and placebo capsules, identical in appearance, will be identically packed; two packs for each participant, the first pack containing 30 tablets for the first month intake and the second pack containing 60 tablets for the second and third months intake. Sequentially numbered packages will be used for the allocation concealment .The packs will be given to participants in order of their inclusion into the study. The investigator involved in participant recruitment, data collectors and the participant will be blinded. 3 The early menopausal symptoms. Intervention 1: Intervention group: Recieving Menohelp Barij® 550 mg Herbal Capsule , containing Extracts of Actaea racemosa L., Glycine max , Dioscorea villosa, Arctium lappa and Vitex agnus- castus; standardized based on at least 40 mg total phenolic according to daidzein and 3 mg diosgenin in each capsule, produced by Barij Essence Pharmaceutical company, Kashan-Iran; once daily for 90 days. Intervention 2: Control group: placebo capsules identical to Menohelp Barij® herbal capsules; produced by Barij Essence Pharmaceutical company, Kashan-Iran; once daily for 90 days. Yes - There is a plan to make this available What will be shared: All deidentified IPD can be shared. When: Starting soon after publication of the study results for ten years. To whom: Data will be available for researchers working in academic institutions, as well as to chief editor and reviewers of the submitted manuscript. Conditions: The data will be available to researchers upon request and submission of the proposal to perform meta-analysis using IPD. Also, in exceptional cases, data will be made available to chief-editor of the journals for checking. Where to obtain: Refer to the email addresses (alizades@tbzmed.ac.ir, drbekhradi@barijessence.com). How to obtain: The requests should be sent by email and data will be available within two week. Comments:
public Reza Bekhradi
Mashhad Ardehal, P.O.Box: 1178
Kashan Iran (Islamic Republic of) 3795191916 +98 86 4854 0000 drbekhradi@barijessence.com Barij Medicinal Plants Research Center scientific Sakineh Mohammad-Alizadeh-Charandabi
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 1477 2699 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Aged 50-59 years 12-72 months after last menstrual period Natural menopause Having at least 3 hot flashes daily during one week follow-up Living with husband BMI 18 to 30 kg/m2 Having a least 6 years Education 50 years 59 years Female Contraindications for hormone therapy, including history of breast cancer, endometrial hyperplasia, or any estrogen-related cancers in the woman or her first-degree family Use of hormone therapy during past 3 months Allergy to estrogen or medicinal herbs Any history of cervical cancer, liver diseases, kidney diseases, gastrointestinal diseases, coagulation diseases, depression or hyperthyroidism. Surgery during the past 3 months Chronic diseases requiring treatment including severe hypertension (160/110) and known diabetes, or malabsorption syndrome Myocardial or cerebral infarction over the past 3 months or History of complicated myocardial or cerebral infarction History of venous thrombosis history of known fibromyoma Heavy smoker (more than 15 cigarettes/day) Regular consumption of alcoholic beverages and alcohol dependence N95 Menopausal and other perimenopausal disorders Treatment - Drugs Treatment - Drugs Intervention group: Recieving Menohelp Barij® 550 mg Herbal Capsule , containing Extracts of Actaea racemosa L., Glycine max , Dioscorea villosa, Arctium lappa and Vitex agnus- castus; standardized based on at least 40 mg total phenolic according to daidzein and 3 mg diosgenin in each capsule, produced by Barij Essence Pharmaceutical company, Kashan-Iran; once daily for 90 days. Control group: placebo capsules identical to Menohelp Barij® herbal capsules; produced by Barij Essence Pharmaceutical company, Kashan-Iran; once daily for 90 days Overall score and sub-scales (vasomotor, physical, psychological, and sexual symptoms) of early menopausal symptoms. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Green climacteric scale. Number of daily hot flashes. Timepoint: before intervention and 4 and 12 weeks after intervention. Method of measurement: daily registration form. Severity of hot flashes. Timepoint: before intervention and 4 and 12 weeks after intervention. Method of measurement: daily registration form. Total and subscales scores of quality of life. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: The Menopause-Specific Quality of Life (MENQOL). Total improvement status for early symptoms of menopause. Timepoint: 4 and 12 weeks after intervention. Method of measurement: one question with three Likert options. Quality of sleep score. Timepoint: 4 weeks after intervention. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI). Barij Essence Pharmaceutical Company Approved 2019-12-10 Ethics committee of Tabriz University of Medical Sciences No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)