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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beyond Hormone Supplement | Experimental | Participants in this arm will receive the Beyond Hormone supplement. |
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| Placebo | Placebo Comparator | Participants in this arm will receive a placebo consisting of rice flour encapsulated in a vegetable cellulose capsule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beyond Hormone | Dietary Supplement | Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone) | Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants' Perceptions of Quality of Life | Evaluation of participants' perceptions of the product's effects on quality of life with a self-reported questionnaire. | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) |
| Participants' Mood and Energy Levels using the Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| Placebo | Other | Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles. |
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Assessment of participants' mood and energy levels using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). |
| Baseline (Day 0), Midline (Day 45), and Endline (Day 90) |
| Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD) | Evaluation of participants' monthly cycle symptoms using the Menstrual Cycle Symptom Diary (MCSD). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) |
| Participants' Libido using a Libido Questionnaire | Assessment of participants' libido using a Libido Questionnaire. These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period). | Baseline (Day 0), Midline (Day 45), and Endline (Day 90) |