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IRCT20231227060537N1 IRCT 2024-02-24 Islamic Azad University The effect of Omega-3 and Vitamin B6 supplements on menopausal symptoms The effect of vitamin b6 and omega-3 supplementation on hot flashes and mood states in menopause women 2024-03-01 anticipated 60 Complete https://irct.ir/trial/74637 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization method; In this method, each member of the desired society is selected with the same probability.To randomize the three groups, we generate a random number between 1 and 3 using the computer, according to the number of the studied sample; Then each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient number is written on each envelope, and the first patient who is registered in the study and enters the study is given the envelope corresponding to patient no. 1, patient number 2 will be given envelope number 2 and so on, and this work will continue until the end of the study sample. In order to maintain randomization, the person who prepares the envelopes (research assistant) will be different from the person who registers the patients and provides the envelopes to the patients (researcher), Blinding description: After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. The numbered numbers are given to the researcher by the assistant of the researcher and the patients are entered into the study in the order of the numbers, and the researcher will not know about the contents of the packages. Therefore, the present study is double-blind. Also, the pill package of each group is the same in terms of shape, color and size and is delivered to the client in the package. N/A Menopausal symptoms, hot flashes, mood states. Intervention 1: Intervention group: daily intake of omega 3 fatty acids and vitamin b6 capsules (omega 3 1000 mg + vitamin B6 40 mg) for 8 weeks. Intervention 2: Intervention group: Daily intake of omega 3 fatty acids capsules (omega 3 1000 mg) for 8 weeks. Intervention 3: Control group: Daily intake of placebo capsules (placebo 1000 mg) for eight weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Roxana Abdolmaleki
No. 153, east khayam Ave, north mehrvilla, karaj
Karaj Iran (Islamic Republic of) 3133617853 +98 26 3442 1653 roxanaabdolmaleki@gmail.com Islamic Azad University scientific Roxana Abdolmaleki
No. 153, east khayam Ave, north mehrvilla, karaj
Karaj Iran (Islamic Republic of) 3133617853 +98 26 3442 1653 roxanaabdolmaleki@gmail.com Islamic Azad University Iran (Islamic Republic of) Iranian nationality literate age 40 to 60 years 12 months or more have passed since the cessation of menstruation normal menopause At the time of the research, she complained of hot flashes and mood problems 40 years 60 years Female Taking hormonal drugs and sedatives Active drug therapy for vasomotor symptoms Experiencing stressful factors such as the death of a first-degree relative or separation from a spouse Suffering from diseases such as blood pressure, diabetes, mental diseases History of drug and tobacco use Activity more than 150 minutes per week F28 Other psychotic disorder not due to a substance or known physiological condition Treatment - Drugs Treatment - Drugs Treatment - Other Intervention group: daily intake of omega 3 fatty acids and vitamin b6 capsules (omega 3 1000 mg + vitamin B6 40 mg) for 8 weeks Intervention group: Daily intake of omega 3 fatty acids capsules (omega 3 1000 mg) for 8 weeks Control group: Daily intake of placebo capsules (placebo 1000 mg) for eight weeks Severity of menopause symptoms. Timepoint: The beginning of the study, the end of the eighth week. Method of measurement: Based on the Menopause Rating Scale (MRS) questionnaire. Mood states. Timepoint: The beginning of the study, the end of the eighth week. Method of measurement: based on The Mood and Anxiety Symptoms Questionnaire (MASQ-D30). Islamic Azad University Approved 2022-11-15 Ethics committee of Islamic Azad University- Science and Research Branch 3rd floor, Unit 6, No. 153, Khayyam East St., Mehravila North Karaj Alborz Iran (Islamic Republic of)