Climacteric Syndrome, Menopause
Conditions
Keywords
Succinate, B complex vitamins, menopause
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).
Interventions
DIETARY_SUPPLEMENTAmberen
Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
DIETARY_SUPPLEMENTSmart B
Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
DIETARY_SUPPLEMENTPlacebo
Placebo capsules are identical to Amberen and Smart B capsules.
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
42 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spilberger-Hanin (Situational anxiety) | week 12 | The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale |
| Spilberger-Hanin (Personal anxiety) | week 12 | The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale |
| Spilberger-Hanin (Actual anxiety) | 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 (well-being) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Anxiety (measured by Hospital Anxiety and Depression Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Depression (measured by Hospital Anxiety and Depression Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loss of interest in most things symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling unhappy or depressed symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Crying spells symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Irritability symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling dizzy or faint symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Pressure or tightness in head or body symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Parts of body feeling numb or tingling symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Hot flushes symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Muscle or joint pains symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Loss of feeling in hands or feet symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Breathing difficulties symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Sweating at night symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Loss of interest in sex symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Blood plasma estradiol levels, pg/ml | week 12 | Statistically significant reduction in the levels, compared between arms |
| Weight, kg | week 12 | Statistically significant reduction in the measurement, compared between arms |
| Headaches symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Heart beating quickly and strongly symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling tense or nervous symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Difficulty in sleeping symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Excitable symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Attacks of panic symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Difficulty in concentrating symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling tired or lacking in energy symptom (Greene Climacteric Scale) | week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
Countries
Russia
Outcome results
None listed