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

Determining 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

Random assignment was done by the use of computer-generated random numbers. Population and sample size: In the study 54 patients who having menopause symptom among patients of eligible and referred to Kousar hospital affiliated to Qazvin University of Medical Sciences, Qazvin, Iran, will be selected.

The present study will be performed in Kousar hospital affiliated to Qazvin University of Medical Sciences, Qazvin, Iran. Patients are randomly divided into two groups receiving supplements and placebo. All people taking the supplement or placebo will take the medicine for eight weeks. Before and after the intervention, venous blood samples will be taken from the patient after 12 hours of fasting for relevant tests.

Inclusion criteria: fatty liver, no gastrointestinal diseases, no smoking and alcohol Exclusion criteria: thyroid disease, breast and ovary cancer , diabetes, Liver disorders, nerves, blood pressure, taking anticoagulants

Patients will be assigned to receive either combined extract (intervention group: n=27) or placebo (control group: n=27).

Clinical signs including symptoms and complications of menopause respect to vasomotor, psychosocial, and physical activity, and also biomarkers of oxidative stress and inflammation in patients with menopausal symptoms will be measured before and after the intervention.

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.

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.

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