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IRCT20170430033730N8 IRCT 2021-03-11 Qazvin University of Medical Sciences The Combined Effect of black cohosh, soybean, arctium lappa L and vitex agnus- castus extracts On menopause The Combined Effect of black cohosh, soybean, arctium lappa L and vitex agnus- castus extracts on clinical symptoms, biomarkers of oxidative stress biomarkers and inflammation among menopausal women 2021-02-13 anticipated 54 Complete https://irct.ir/trial/53925 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 54 eligible patients are assigned to groups A and B equally using the balanced block randomization method and the online system sealedenvelope.com. The relevant list is generated using blocks with variable sizes of 6 and 8. The created list consists of eight blocks, of which five blocks are 6 and three blocks are 8. The order of the blocks and the people in each block is completely random and each person is assigned a unique code.54 similar envelopes are selected. A unique code is registered on each package based on the mentioned list. Depending on the study groups, supplement (A) or placebo (B) is included. The envelopes are closed and each envelope is assigned to one participant, Blinding description: Placebo is used for blinding. Supplements and placebo are poured into containers that are similar in size, shape and appearance. Instead of group names, each container is assigned a unique code. The researchers and the patient are blind until the final analysis. N/A menopause. Intervention 1: Intervention group: will receive two capsules of 550 mg of combined extract(Black cohosh, Soybean, Sweet potato, Greater burdock, Vitex) twice daily for 8 weeks. The capsules are manufactured by Barij Essence Pharmaceutical Company, Kashan, Iran. Intervention 2: Control group: Will take two capsules of 550 mg of placebo twice daily for 8 weeks. The Placebo are manufactured by Barij Essence Pharmaceutical Company, Kashan, Iran. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Seyyed Mehdi Mirhashemi
Shahid Bahonar Blovard
Qazvin Iran (Islamic Republic of) 34197-59811 +98 28 3333 6001 mirhashemism@gmail.com Qazvin University of Medical Sciences scientific Seyyed Mehdi Mirhashemi
Shahid Bahonar Blovard
Qazvin Iran (Islamic Republic of) 34197-59811 +98 28 3333 6001 mirhashemism@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Having menopausal symptoms 45 years 55 years Female patients who do not want to cooperate People who smoke People who drink alcohol Patients with gastrointestinal disorders Diabetic Patients Thyroid disease, breast and ovarian cancer, liver and neurological disorders, high blood pressure, taking anticoagulants N95 Menopausal and other perimenopausal disorders Treatment - Drugs Placebo Intervention group: will receive two capsules of 550 mg of combined extract(Black cohosh, Soybean, Sweet potato, Greater burdock, Vitex) twice daily for 8 weeks. The capsules are manufactured by Barij Essence Pharmaceutical Company, Kashan, Iran. Control group: Will take two capsules of 550 mg of placebo twice daily for 8 weeks. The Placebo are manufactured by Barij Essence Pharmaceutical Company, Kashan, Iran. Clinical symptoms. Timepoint: Beginning and end of the study. Method of measurement: Quality of life questionnaire for menopausal women. Glutathione. Timepoint: Beginning and end of the study. Method of measurement: Spectrophotometry. MDA. Timepoint: Beginning and end of the study. Method of measurement: Spectrophotometry. TNF-α. Timepoint: Beginning and end of the study. Method of measurement: ELISA. IL-8. Timepoint: Beginning and end of the study. Method of measurement: ELISA. Gonadotropins. Timepoint: Beginning and end of the study. Method of measurement: ELISA. E2. Timepoint: Beginning and end of the study. Method of measurement: ELISA. Qazvin University of Medical Sciences Approved 2020-02-29 Ethics committee of Qazvin University of Medical Sciences Shahid Bahonar Boulevard Qazvin Qazvin Iran (Islamic Republic of)