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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118908
• Other study ID #: AmberenSmartB-2017
• Status: Completed
• Phase: N/A
• First received: April 13, 2017
• Last updated: October 18, 2017
• Start date: April 24, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: July 2017
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Climacteric Syndrome
• Menopause
• Syndrome

Intervention

Dietary Supplement:
• Amberen
Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
• Smart B
Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
• Placebo
Placebo capsules are identical to Amberen and Smart B capsules.

Locations

Country	Name	City	State
Russian Federation	Sechenov First Moscow Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spilberger-Hanin (Situational anxiety)	The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale	week 12
Primary	Spilberger-Hanin (Personal anxiety)	The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale	week 12
Primary	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
Primary	WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Primary	WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Primary	WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Primary	Anxiety (measured by Hospital Anxiety and Depression Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Primary	Depression (measured by Hospital Anxiety and Depression Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Feeling tense or nervous" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Difficulty in sleeping" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Excitable" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Attacks of panic" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Difficulty in concentrating" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Loss of interest in most things" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Feeling unhappy or depressed" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Crying spells" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Irritability" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Feeling dizzy or faint" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Headaches" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Muscle or joint pains" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	Breathing difficulties" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Hot flushes" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Sweating at night" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	"Loss of interest in sex" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	week 12
Secondary	Blood plasma estradiol levels, pg/ml	Statistically significant reduction in the levels, compared between arms	week 12
Secondary	Weight, kg	Statistically significant reduction in the measurement, compared between arms	week 12