Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B by Women With Climacteric Syndrome

I.M. Sechenov First Moscow State Medical University2 个研究点分布在 2 个国家目标入组 107 人开始时间: 2017年4月24日最近更新: 2017年10月20日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: I.M. Sechenov First Moscow State Medical University
入组人数: 107
试验地点: 2
主要终点: Spilberger-Hanin (Personal anxiety)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart B by women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms.

详细描述

To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B (vs placebo) by women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause in regards to vasomotor, endocrine-metabolic, and neuro-psychological dysfunctions;
To evaluate safety of combined use of dietary supplements Amberen and Smart B (vs placebo) by women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause, lasting no less than 1 year in regards to vasomotor, endocrine-metabolic, and neuro-psychological dysfunctions;
To develop recommendations for combined use of dietary supplements Amberen and Smart B for women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause (menopausal for at least 1 year).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 42 Years 至 60 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Female patients, 42-60 years of age;
•Patient with diagnosis of "climacteric syndrome", in typical or non-complicated form, mild or moderate vegetative symptoms during menopause i.e. absence of menstrual period for at least 1 year;
•Ability to read and understand informed consent form for the study's participation;
•Patients without risk factors and changes in the breast tissue based on the mammogram;
•Patients with medical history of risk factors without changes in the breast tissue;
•Ability to adhere to the conditions of the study.

排除标准

•Presence of female reproductive system cancers (breast cancer, cervical cancer etc.);
•Presence of extragenital oncological conditions, except those in complete remission for 5 years or more;
•Conditions requiring emergency or planned hospitalization in the next 6 months;
•Presence of hormonally-active extragenital endocrine diseases (thyroid, adrenal, pituitary, hypothalamus);
•Surgical interventions done on sex organs or breasts, 1 year or less prior to the screening;
•Any surgeries done less than 3 months prior to the screening;
•Patients receiving HRT;
•Psychiatric conditions;
•Diabetes;
•Total ovariectomy
•Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the study
•High risk of non-compliance

结局指标

主要结局

Spilberger-Hanin (Personal anxiety)

时间窗: week 12

The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale

Spilberger-Hanin (Actual anxiety)

时间窗: week 12

The decrease of actual anxiety, measured as statistically significant reduction of the score in corresponding subscale. Actual anxiety as a sum of situational and personal anxiety scores was introduced by Hanin in his modification of original State-Trait Anxiety Inventory.

WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood)

时间窗: week 12