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The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on symptoms of menopause and hormone levels, as compared to a placebo.
Participants will take one of two extracts or a placebo every day for 84 days; outcomes of self-report menopausal symptoms collected on a trio of scales will provide information on effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant Extract 1 | Experimental | Participants in this arm will take an ashwagandha root supplement each day for 84 days. |
|
| Plant Extract 2 | Experimental | Participants in this arm will take an ashwagandha root and leaf supplement each day for 84 days. |
|
| Placebo | Placebo Comparator | Participants in this arm will take an inert placebo each day for 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ashwagandha root | Dietary Supplement | This substance is extracted from the root of the plant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proprietary Menopause Symptom Scale (NRI-MSS) | Nutraceuticals Research Institute's Menopause Symptom Scale is a validated self-report scale measuring symptoms across 6 domains. Scores range from 0-30, with higher scores indicating greater symptom severity. | days 0, 28, 56, and 84 |
| Menopause-Specific Quality of Life (MenQoL) | The MenQoL evaluates quality of life among menopausal women. Scores range from 0-8 with higher scores indicating greater symptom severity. | days 0, 28, 56, and 84 |
| Menopause Rating Scale (MRS) | The MRS is a self report assessment of menopausal symptoms with scores ranging from 0-44. Higher scores indicate greater symptom severity. | Days 0, 28, 56, and 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Estriol | Laboratory test for estriol levels | days 0, 84 |
| Estradiol | Laboratory test for estradiol levels | days 0, 84 |
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Inclusion Criteria:
Exclusion Criteria:
Biological sex of woman, gender identity of female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessie Cavanaugh, PhD | Contact | 256-203-9010 | j.cavanaugh@nutraceuticalsresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutraceuticals Research Institute | Huntsville | Alabama | 35801 | United States |
Data is available with IRB authorization and consent from all participants.
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| ashwagandha root and leaf | Dietary Supplement | This substance is extracted from both the root and leaves of the plant. |
|
| Placebo | Other | The inert placebo does not contain any of the plant matter. |
|
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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