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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a 24-week, single-arm, open-label, virtual study evaluating the effects of Elix Cycle Balance and Elix Daily Harmony on uterine fibroid-related symptoms and quality of life in 42 participants. Participants will self-administer the investigational herbal supplements daily and complete validated questionnaires at scheduled timepoints to assess symptom severity and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elix Cycle Balance & Elix Daily Harmony | Experimental | Participants will receive two investigational herbal supplements daily for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elix Daily Harmony | Dietary Supplement | Each morning, 1-2 hours after their first meal, they will mix the following into room-temperature or warm water and consume: Elix Daily Harmony: 3 droppers full (approximately 2.5 mL) Elix Cycle Balance: 6 droppers full (approximately 5.0 mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in uterine fibroid-related symptom severity | Measured as change in menstrual pain and bleeding volume using the validated Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL) total and subscale scores. | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fibroid-related health-related quality of life domains | Measured as change in self-reported scores on UFS-QOL and study-specific questions addressing energy levels, emotional well-being, self-consciousness, sleep quality, and limitations in daily and social activities. | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Renner, MSc | Contact | 4242450284 | hello@citruslabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Recruiting | Las Vegas | Nevada | 89118 | United States |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |