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IRCT20220417054567N1 IRCT 2022-05-23 Hamedan University of Medical Sciences Comparison the effect of fennel and vitex ندارد Comparison the effect of fennel, vitex and placebo oral products on menopausal problems in menopaused women : a double -blind randomized clinical trial 2022-05-10 anticipated 135 Complete https://irct.ir/trial/63068 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: both women and researchers are blinded, Randomization description: By the method of six random blocks, people will be randomly assigned to one of the three groups A, B, or C. For this purpose, six sheets of paper are prepared. The letter A (intervention with fennel) is written on two sheets, the letter B ( intervention with vitex) is written on two sheets, and the letter C (control) is written on the other two sheets. The sheets are mixed together and selected by the researcher sequentially without replacement. This operation is repeated to the number of eligible patients and the group A, B, or C of each patient is recorded in front of the patient's visit and only with the knowledge of the researcher, Blinding description: Fennel, five-fingered, and placebo are prepared by the researcher in the form of similar capsules and will be given to the doctor. However, the patient's physician and the patient themselves will not know any of the contents of the labeled capsules. The doctor will be told to use capsule 1 for patient # 1. In the same way, all patients are numbered based on their turn and the capsule with the same number is used for them. 3 Menopausal singe. Intervention 1: Take fennel capsules containing one gram of fennel fruit once a day. Intervention 2: : Vitex Capsule containing VITEX AGNUS-CASTUS product in the amount of 4.8 - 3.2 mg and its standardization according to the composition of Ecobin. Intervention 3: Control group: placebo(starch capsule). 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 I have not yet searched for the right journal
public Dr.Mehdi Biglarkhani
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 0717 mahdibiglarkhani@gmail.com Hamedan University of Medical Sciences scientific Mojgan Nazari
Namjou boulevard
Rasht Iran (Islamic Republic of) 3697-419338 33329421-013 . moj.na1346@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Menopausal women 45-65 years who have not been menstruating for at least the past year Do not take any other medicine to treat menopausal problems Complaints of any of the physical complications of menopause No cardiovascular and liver disease No history of breast or endometrial cancer in yourself or a first-degree family No addiction to smoking and alcohol Do not have diabetes Satisfaction to participate in the project 45 years 65 years Female Allergy to prescribed drugs Do not take prescribed medications for at least a week Treatment - Drugs Treatment - Drugs Placebo Take fennel capsules containing one gram of fennel fruit once a day : Vitex Capsule containing VITEX AGNUS-CASTUS product in the amount of 4.8 - 3.2 mg and its standardization according to the composition of Ecobin Control group: placebo(starch capsule) Improve menopausal symptoms. Timepoint: At the beginning of the study,4 and 8 weeks later. Method of measurement: Base on research sample. Hamedan University of Medical Sciences Approved 2022-04-09 Ethic committee of Hamadan Medical Sciences University Boulevard Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)