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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Climacteric Syndrome, Menopause

Intervention / Treatment
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* Dietary Supplement: Amberen
* Dietary Supplement: Smart B
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amberen and Smart B<br>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. | Dietary Supplement: Amberen<br>* Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.<br>Dietary Supplement: Smart B<br>* Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.<br>|
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo<br>* Placebo capsules are identical to Amberen and Smart B capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spilberger-Hanin (Situational anxiety) | The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale | week 12 | 
| Spilberger-Hanin (Personal anxiety) | The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale | 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. | week 12 | 
| WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Anxiety (measured by Hospital Anxiety and Depression Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Depression (measured by Hospital Anxiety and Depression Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart beating quickly and strongly symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Feeling tense or nervous symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Difficulty in sleeping symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Excitable symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Attacks of panic symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Difficulty in concentrating symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Feeling tired or lacking in energy symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Loss of interest in most things symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Feeling unhappy or depressed symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Crying spells symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Irritability symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Feeling dizzy or faint symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Pressure or tightness in head or body symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Parts of body feeling numb or tingling symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Headaches symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Muscle or joint pains symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Loss of feeling in hands or feet symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Breathing difficulties symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Hot flushes symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Sweating at night symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Loss of interest in sex symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | week 12 | 
| Blood plasma estradiol levels, pg/ml | Statistically significant reduction in the levels, compared between arms | week 12 | 
| Weight, kg | Statistically significant reduction in the measurement, compared between arms | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Succinate, B complex vitamins, menopause