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| Name | Class |
|---|---|
| Analysis and Research Network, S.L | OTHER |
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This observational study will assess the effects of a dietary supplement based on Humulus Lupulus L. to relieve the symptoms of menopause in perimenopausal and postmenopausal women, by doing a follow up of the Cervantes scale and the Anxiety and depression Goldberg Scale in a period of 6 months. Participants will be allocated to dietary supplement being the difference between groups if they are perimenopausal or postmenopausal, and will attend to 3 visits (baseline, 3 months and 6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perimenopausal | Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. |
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| Postmenopausal | Patients in this group will take one capsule of a dietary supplement containing Humulus lupulus L. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humulus lupulus L | Dietary Supplement | Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale | Score on the Cervantes Scale on quality of life. The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value. | Change from baseline, to 3 months and 6 months visit |
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Menopause and Health. | This domain of the Cervantes Scale is composed of 15 items, punctuated from 0 to 5. This domain ranges from 0 to 75, where 0 corresponds to abscence of physical symptoms, and 75 to the maximum level of physical problems. | Change from baseline, to 3 months and 6 months visit |
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Sexuality. | This domain of the Cervantes Scale is composed of 4 items, punctuated from 0 to 5. This domain ranges from 0 to 20, where 0 corresponds to abscence of sexual problems, and 20 to the maximum level of sexual problems. | Change from baseline, to 3 months and 6 months visit |
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Psychic. | This domain of the Cervantes Scale is composed of 9 items, punctuated from 0 to 5. This domain ranges from 0 to 45, where 0 corresponds to abscence of anxiety and depression problems, and 45 to the maximum level of anxiety and depression problems. | Change from baseline, to 3 months and 6 months visit |
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale, domain: Couple relationship. | This domain of the Cervantes Scale is composed of 3 items, punctuated from 0 to 5. This domain ranges from 0 to 15, where 0 corresponds to abscence of relationship problems, and 15 to the maximum level of relationship problems. |
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Inclusion Criteria:
Exclusion Criteria:
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Women between 40 and 60 years old that attend ginecological consultation in Spain.
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| Change from baseline, to 3 months and 6 months visit |
| Cervantes personality scale. | The scale is composed of 20 questions divided in 3 domains. Each question is punctuated from 0 to 5. First domain is introversion, it is comprised of 7 Items. This domain is punctuated from 0 to 10, where 0 represents a more extroverted personality and 10 more introverted. Second domain is emotional instability, it is comprised of 7 Items. This domain is punctuated from 0 to 35, where 0 represents more emotional stability and 35 more emotional instability. Third domain is sincerity, it is comprised of 6 Items. This domain is punctuated from 0 to 30, where 0 represents less sincere and 30 more most sincere. | Measured at Baseline visit |
| Change in anxiety and depression - Measured with Score on the Anxiety and Depression Goldberg Scale | The scale is composed of 18 items. Each item is punctuated from 0 to 5. And total scale result ranges from 0 to 90, where 0 corresponds to depression unlikely and more than 54 to severe depression. | Change from baseline, to 3 months and 6 months visit |
| Number of adverse events | Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product | Through the study, an average of 9 months. |
| Compliance with treatment | Recount of product returned at the 3 months visit and at the 6 months visit of study. | 6 months |
| Treatment satisfaction | Treatment satisfaction is measured in three questions valued from 0 to 10, where 0 is considered worst and 10 better. The three questions are about:
| Measured at the 6 months visit |