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

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ClinicalTrials.gov Identifier: NCT03118908
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Kuznetsova Irina, 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.

Condition or disease Intervention/treatment Phase
Climacteric Syndrome Menopause Dietary Supplement: Amberen Dietary Supplement: Smart B Dietary Supplement: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen and Smart B by Women With Climacteric Syndrome
Actual Study Start Date : April 24, 2017
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Spilberger-Hanin (Situational anxiety) [ Time Frame: week 12 ]
    The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale

  2. Spilberger-Hanin (Personal anxiety) [ Time Frame: week 12 ]
    The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale

  3. Spilberger-Hanin (Actual anxiety) [ Time Frame: 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.

  4. WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (well-being) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  5. WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (activity) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  6. WELL-BEING, LEVEL OF ACTIVITY, MOOD QUESTIONNAIRE (mood) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  7. Anxiety (measured by Hospital Anxiety and Depression Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  8. Depression (measured by Hospital Anxiety and Depression Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms


Secondary Outcome Measures :
  1. "Heart beating quickly and strongly" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  2. "Feeling tense or nervous" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  3. "Difficulty in sleeping" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  4. "Excitable" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  5. "Attacks of panic" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  6. "Difficulty in concentrating" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  7. "Feeling tired or lacking in energy" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  8. "Loss of interest in most things" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  9. "Feeling unhappy or depressed" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  10. "Crying spells" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  11. "Irritability" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  12. "Feeling dizzy or faint" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  13. "Pressure or tightness in head or body" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  14. "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  15. "Headaches" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  16. "Muscle or joint pains" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  17. "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  18. Breathing difficulties" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  19. "Hot flushes" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  20. "Sweating at night" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  21. "Loss of interest in sex" symptom (Greene Climacteric Scale) [ Time Frame: week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  22. Blood plasma estradiol levels, pg/ml [ Time Frame: week 12 ]
    Statistically significant reduction in the levels, compared between arms

  23. Weight, kg [ Time Frame: week 12 ]
    Statistically significant reduction in the measurement, compared between arms



Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118908


Locations
Russian Federation
Sechenov First Moscow Medical University
Moscow, Russian Federation, 119991
Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University

Responsible Party: Kuznetsova Irina, Chief Researcher, Scientific Research Centre, Women's Health Scientific Research Department, I.M. Sechenov First Moscow State Medical University, University hospital #2, Obstetrics and Gynecology clinic., I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT03118908     History of Changes
Other Study ID Numbers: AmberenSmartB-2017
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University:
Succinate
B complex vitamins
menopause

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes