Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome

I.M. Sechenov First Moscow State Medical University107 enrolled

Overview

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.

1. 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; 2. 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; 3. 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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

107

Conditions

Climacteric Syndrome Menopause

Interventions

AmberenDIETARY_SUPPLEMENT

Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.

Smart BDIETARY_SUPPLEMENT

Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.

PlaceboDIETARY_SUPPLEMENT

Placebo capsules are identical to Amberen and Smart B capsules.

Eligibility

Sex: FEMALEMin age: 42 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Sechenov First Moscow Medical University

Moscow, Russia

Outcomes

Primary Outcomes

Spilberger-Hanin (Situational anxiety)

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

Time frame: week 12

Spilberger-Hanin (Personal anxiety)

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

Time frame: week 12

Spilberger-Hanin (Actual anxiety)

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.

Time frame: week 12

WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being)