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Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.

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ClinicalTrials.gov Identifier: NCT03897738
Recruitment Status : Active, not recruiting
First Posted : April 1, 2019
Last Update Posted : August 26, 2019
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 in women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms in perimenopause.

Condition or disease Intervention/treatment Phase
Perimenopause, Climacteric Syndrome 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 in women vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.
  2. To evaluate safety of combined use of dietary supplements Amberen and Smart B in women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.
  3. To develop recommendations for combined use of dietary supplements Amberen and Smart B for women with vasomotor, psychosomatic, psychological and other climacteric symptoms in perimenopause.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 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 in Women With Climacteric Syndrome in Perimenopause
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 26, 2019

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.

Placebo capsules are identical to Amberen and Smart B capsules.

Dietary Supplement: Placebo
Placebo capsules are identical to Amberen and Smart B capsules.




Primary Outcome Measures :
  1. "Heart beating quickly and strongly" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 1 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  2. "Feeling tense or nervous" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 2 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  3. "Difficulty sleeping" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 3 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  4. "Increased Excitability" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 4 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  5. "Panic attacks" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 5 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  6. "Difficulty concentrating" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 6 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  7. "Feeling tired or lacking energy" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 7 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  8. "Loss of interest in most things" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 8 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  9. "Feeling of sadness or depression" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 9 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  10. "Crying spells" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 10 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  11. "Irritability" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 11 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  12. "Feeling dizzy or faint" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 12 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  13. "Pressure or tightness in head or body" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 13 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  14. "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 14 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  15. "Headaches" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 15 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  16. "Muscle or joint pains" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 16 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  17. "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 17 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  18. "Breathing difficulties" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 18 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  19. "Hot flushes" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 19 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  20. "Night sweats" symptom (Greene Climacteric Scale) [ Time Frame: 90 days and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 20 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  21. "Loss of interest in sex" symptom (Greene Climacteric Scale) [ Time Frame: 90 and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. This is question 21 of the Greene Climacteric Scale; the subjects rank degrees of bother of the symptom as 1 = "not at all"; 2 = "a little bit"; 3 = "quite a bit"; 4 = "extremely"

  22. Blood plasma estradiol levels, pg/ml [ Time Frame: 90 and 180 days ]
    Statistically significant changes in the levels, compared between arms


Secondary Outcome Measures :
  1. State-Trait Anxiety Inventory (State anxiety sub-scale) [ Time Frame: 90 and 180 days ]
    Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

  2. State-Trait Anxiety Inventory (Trait anxiety sub-scale) [ Time Frame: 90 and 180 days ]
    Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

  3. State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales ) [ Time Frame: 90 and 180 days ]
    Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

  4. Well-being sub-score (Russian well-being, activity and mood questionnaire) [ Time Frame: 90 and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. The sub-scale score varies from 10 to 70 points, with the higher score corresponding to more positive self-evaluation of well-being.

  5. Activity sub-score (Russian well-being, activity and mood questionnaire) [ Time Frame: 90 and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. The sub-scale score varies from 10 to 70 points, with the higher score corresponding to more positive self-evaluation of one's activity.

  6. Mood sub-score (Russian well-being, activity and mood questionnaire) [ Time Frame: 90 and 180 days ]
    Statistically significant change in designated symptom severity, compared between arms. The sub-scale score varies from 10 to 70 points, with the higher score corresponding to more positive self-evaluation of one's mood.

  7. Anxiety sub-score (measured by Hospital Anxiety and Depression Scale) [ Time Frame: 90 and 180 days ]

    Statistically significant change in designated symptom severity, compared between arms. The scores range from 0 to 21.

    0-7 = Normal 8-10 = Borderline abnormal 11-21 = Abnormal


  8. Depression sub-score (measured by Hospital Anxiety and Depression Scale) [ Time Frame: 90 and 180 days ]

    Statistically significant change in designated symptom severity, compared between arms. The scores range from 0 to 21.

    0-7 = Normal 8-10 = Borderline abnormal 11-21 = Abnormal




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subjects, 50 years of age or younger;

    • Subjects in the second phase of menopausal transition as per STRAW 10+ i.e. interval of amenorrhea 60 days or more (with regular menstrual cycle during earlier reproductive stages).
    • Subjects with diagnosis of mild to moderate climacteric syndrome;
    • Recent (up to 12 months prior to study enrollment) breast exam results, including mammogram, that rule out malignancies;
    • Recent (up to 3 years prior to study enrollment) cytological screening that rules out vaginal cervix malignancies.
    • Ability to read and understand informed consent form for the study's participation;
    • Ability to adhere to the conditions of the study.

Exclusion Criteria:

  • • Postmenopause, including surgical menopause.

    • Presence of hormone-dependent cancers;
    • Presence of other cancers, not in full remission with no recurrence for 5 years or more;
    • Planned hospitalization in the next 6 months;
    • Presence of hormonally-active extragenital endocrine diseases (diabetes; diseases of thyroid, adrenal, pituitary) that require prolonged or life-long therapies
    • Surgical interventions on sex organs or breasts, 1 year or less prior to the screening;
    • Gynecological conditions that may require hormonal therapies or surgeries (uterine myoma, endometriosis, endometrial hyperplasia etc.);
    • Currently undergoing or planning to utilize assisted reproductive technologies;
    • Any abdominal surgeries within less than 3 months prior to the screening;
    • HRT including MHRT or hormonal contraceptives - current or within less than 3 months prior to the screening;
    • Psychiatric conditions;
    • Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the trial;
    • 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): NCT03897738


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

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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: NCT03897738     History of Changes
Other Study ID Numbers: AmberenSmartB-2019
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
perimenopause
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes