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

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Menopause; Climacteric Syndrome

Treatments: Dietary Supplement: Smart B; Dietary Supplement: Amberen; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03118908

AmberenSmartB-2017

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 107 patients

Sex: Female

Ages: 42 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 2 patient groups, including a placebo group

Amberen and Smart B

Experimental group

Description:

Amberen - a dietary supplement: 2 capsules (one while capsule 200 mg and one orange capsule 200 mg) are taken once a day with a meal, preferably after breakfast, for 3 months. SMART В - a dietary supplement: 1 capsule per day (166 mg) is taken once a day with a meal, preferably after breakfast, for 3 months, concurrently with Amberen.

Treatment:

Dietary Supplement: Smart B

Dietary Supplement: Amberen

Placebo

Placebo Comparator group

Description:

Placebo is taken as follows: 3 capsules (one while capsule 200 mg, one orange capsule 200 mg, one capsule 166mg) are taken once a day with a meal, preferably after breakfast, for 3 months.

Treatment:

Dietary Supplement: Placebo