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IRCT20220716055479N1 IRCT 2022-10-17 Behestan Darou Investigating the effect of EstroG-100 herbal extract on the improvement of hot flashes in postmenopausal women in two intervention and control groups. Investigating the effect of EstroG-100 herbal extract on the improvement of hot flashes in postmenopausal women in two intervention and control groups. 2021-12-27 anticipated 70 Complete https://irct.ir/trial/64824 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization method and description of each method: simple randomization, block, Blinding description: Patients and researchers. 1-2 hot flash. Intervention 1: Intervention group: recipient of ESTROG-100, which this plant extract contains a combination of three plant roots (Cynanchum wilfordii Hemsley plants (Catus family), Phlomis umbrosa Turczaninow (Vanaceae family) and Angelica gigas Nakai (Hycanthus hyacinth)) which is in capsule form by It is prepared by Behestan Daro Company in Iran and is provided to the patient. The patient should take 2 capsules daily for 90 days. In addition, the placebo also contains starch in the same packaging and the same color as the original drug. All the people participating in the study were divided into two main and placebo groups after being informed about the method of conducting the study and after completing the informed consent form. Trainings were provided to the participants regarding how to take the medicine, how to complete the questionnaire based on the severity of the hot flashes (mild, moderate and severe types) and weekly visits to receive the medicine. Intervention 2: Control group: Placebo. Yes - There is a plan to make this available What will be shared: All data to (non-identifiable individuals) When: Data access 6-8 months after the publication of the article To whom: researchers Conditions: If the findings obtained in the plan lead to the improvement of women's health and the improvement of menopausal problems Where to obtain: The main author How to obtain: If needed, the study data will be provided to the Shahid Beheshti University of Medical Sciences Research Office and the applicant will be able to access the information through the research office. Comments:
public Golnaz Fallah
Imam Hossein (AS) Medical, below Shahid Madani Metro, Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 golnaz.fallah.talouki@gmail.com Shahid Beheshti University of Medical Sciences scientific Golnaz Fallah
Imam Hossein (AS) Medical, below Shahid Madani Metro, Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 golnaz.fallah.takouli@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Normal BMI Absence of underlying disease no limit no limit Female Unwillingness to participate in the study Use of hormonal drugs containing estrogen and progesterone in the last three months drug use BMI greater than 40 irregular bleeding within 1 year after menopause hysterectomy uncontrolled blood pressure thyroid diseases diabetes mellitus history of hormone related cancers Treatment - Drugs Placebo Intervention group: recipient of ESTROG-100, which this plant extract contains a combination of three plant roots (Cynanchum wilfordii Hemsley plants (Catus family), Phlomis umbrosa Turczaninow (Vanaceae family) and Angelica gigas Nakai (Hycanthus hyacinth)) which is in capsule form by It is prepared by Behestan Daro Company in Iran and is provided to the patient. The patient should take 2 capsules daily for 90 days. In addition, the placebo also contains starch in the same packaging and the same color as the original drug. All the people participating in the study were divided into two main and placebo groups after being informed about the method of conducting the study and after completing the informed consent form. Trainings were provided to the participants regarding how to take the medicine, how to complete the questionnaire based on the severity of the hot flashes (mild, moderate and severe types) and weekly visits to receive the medicine. Control group: Placebo Investigating the hot flush symptoms based on the patients' answers (the criteria of a questionnaire designed with three states of mild, moderate and severe). Timepoint: 12weeks. Method of measurement: In the first visit, for those eligible to enter the study, they were asked to fill out the form related to severity (mild: sudden hot flush, moderate: sudden hot flush with severe sweating, severe: sudden hot flush with Sweating and interference with daily activities), the number of hot flashes (within a week), should be completed weekly from one week before the treatment to 12 weeks after the treatment and delivered at each visit.In case of not being able to visit these people in person, information will be collected on a weekly basis and during phone calls. Medicines were delivered to people in the clinic during three stages at the beginning of the treatment, the end of the 4th week and the end of the 8th week. Behestan Darou Approved 2021-12-21 Ethics committee of Shahid Beheshti University of medical sciences Shahid Beheshti University Tehran Tehran Iran (Islamic Republic of)