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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amberen and Smart B | Experimental | 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 Ð’ - 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amberen | Dietary Supplement | Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms. |
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| Measure | Description | Time Frame |
|---|---|---|
| "Heart beating quickly and strongly" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Feeling tense or nervous" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Difficulty sleeping" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Increased Excitability" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Panic attacks" symptom (Greene Climacteric Scale) | 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" |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory (State anxiety sub-scale) | Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety. | 90 and 180 days |
| State-Trait Anxiety Inventory (Trait anxiety sub-scale) |
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Inclusion Criteria:
Female subjects, 50 years of age or younger;
Exclusion Criteria:
• Postmenopause, including surgical menopause.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sechenov First Moscow Medical University | Moscow | 119991 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38904899 | Derived | Kachko VA, Shulman LP, Kuznetsova IV, Uspenskaya YB, Burchakov DI. Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen(R) and Smart B(R) in Women with Climacteric Syndrome in Perimenopause. Adv Ther. 2024 Aug;41(8):3183-3195. doi: 10.1007/s12325-024-02910-0. Epub 2024 Jun 21. |
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| Smart B | Dietary Supplement | Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate. |
|
| Placebo | Dietary Supplement | Placebo capsules are identical to Amberen and Smart B capsules. |
|
| 90 days and 180 days |
| "Difficulty concentrating" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Feeling tired or lacking energy" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Loss of interest in most things" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Feeling of sadness or depression" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Crying spells" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Irritability" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Feeling dizzy or faint" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Pressure or tightness in head or body" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Headaches" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Muscle or joint pains" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Breathing difficulties" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Hot flushes" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Night sweats" symptom (Greene Climacteric Scale) | 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" | 90 days and 180 days |
| "Loss of interest in sex" symptom (Greene Climacteric Scale) | 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" | 90 and 180 days |
| Blood plasma estradiol levels, pg/ml | Statistically significant changes in the levels, compared between arms | 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. |
| 90 and 180 days |
| State-Trait Anxiety Inventory (Actual anxiety, combination of state and trait sub-scales ) | Statistically significant change of the score in corresponding sub-scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety. | 90 and 180 days |
| Well-being sub-score (Russian well-being, activity and mood questionnaire) | 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. | 90 and 180 days |
| Activity sub-score (Russian well-being, activity and mood questionnaire) | 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. | 90 and 180 days |
| Mood sub-score (Russian well-being, activity and mood questionnaire) | 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. | 90 and 180 days |
| Anxiety sub-score (measured by Hospital Anxiety and Depression Scale) | 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 | 90 and 180 days |
| Depression sub-score (measured by Hospital Anxiety and Depression Scale) | 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 | 90 and 180 days |