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

Not Applicable

Completed

• Conditions: Menopause; Climacteric Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Amberen; Dietary Supplement: Smart B

• Registration Number: NCT03118908
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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).

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-18
• Study Start: 2017-04-24
• Status Verified: 2017-07
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Amberen and Smart B	Amberen	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.
Amberen and Smart B	Smart B	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.

Primary Outcome Measures

Name	Time	Method
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.
Spilberger-Hanin (Personal anxiety)	week 12	The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale
Depression (measured by Hospital Anxiety and Depression Scale)	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
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
Spilberger-Hanin (Situational anxiety)	week 12	The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale
Anxiety (measured by Hospital Anxiety and Depression Scale)	week 12	Statistically significant reduction in designated symptom severity, compared between arms

Secondary Outcome Measures

Name	Time	Method
"Heart beating quickly and strongly" 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
"Loss of interest in most things" 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 tense or nervous" 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
"Muscle or joint pains" 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
"Feeling unhappy or depressed" 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
"Loss of interest in sex" symptom (Greene Climacteric Scale)	week 12	Statistically significant reduction in designated symptom severity, compared between arms
Weight, kg	week 12	Statistically significant reduction in the measurement, 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
"Crying spells" 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
"Loss of feeling in hands or feet" 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
Blood plasma estradiol levels, pg/ml	week 12	Statistically significant reduction in the levels, 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
"Headaches" 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

Trial Locations

Locations (1)

Sechenov First Moscow Medical University; 🇷🇺 Moscow, Russian Federation