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

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause; Climacteric Syndrome
• Intervention / Treatment: Dietary supplement: Amberen; Dietary supplement: Smart B; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Sechenov First Moscow Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: menopause; Succinate; B complex vitamins
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: AmberenSmartB-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No