Clinical trial NCT03118908: Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome
Official title: Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B by Women With Climacteric Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Climacteric Syndrome
Menopause
Keywords: Succinate
B complex vitamins
menopause
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 107
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Spilberger-Hanin (Situational anxiety)
timeFrame: week 12
measure: Spilberger-Hanin (Personal anxiety)
timeFrame: week 12
measure: Spilberger-Hanin (Actual anxiety)
timeFrame: week 12
measure: WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being)
timeFrame: week 12
measure: WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity)
timeFrame: week 12
measure: WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood)
timeFrame: week 12
measure: Anxiety (measured by Hospital Anxiety and Depression Scale)
timeFrame: week 12
measure: Depression (measured by Hospital Anxiety and Depression Scale)
timeFrame: week 12
Secondary outcomes:
measure: "Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Feeling tense or nervous" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Difficulty in sleeping" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Excitable" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Attacks of panic" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Difficulty in concentrating" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Loss of interest in most things" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Feeling unhappy or depressed" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Crying spells" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Irritability" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Feeling dizzy or faint" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Headaches" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Muscle or joint pains" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: Breathing difficulties" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Hot flushes" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Sweating at night" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: "Loss of interest in sex" symptom (Greene Climacteric Scale)
timeFrame: week 12
measure: Blood plasma estradiol levels, pg/ml
timeFrame: week 12
measure: Weight, kg
timeFrame: week 12
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov First Moscow Medical University
Study officials:
References: