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Sponsor funding
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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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An investigation of the dietary supplement marketed as "Premama Balance" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PreMama Balance | Experimental | Each day, the participants will take 1 packet of Premama Balance, dissolved in one glass (8oz+) of water. Premama Balance may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete. At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance. |
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| Placebo Drink | Placebo Comparator | Each day, the participants will take 1 packet of Placebo Drink, dissolved in one glass (8oz+) of water. Placebo Drink may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete. At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PreMama Balance | Dietary Supplement | Premama Balance is a blend of the following: Vitex (Chasteberry Extract), commonly used to help regulate hormones; Antioxidants, Selenium, and Magnesium, also help support the cleansing of hormonal birth control from the liver and help strengthen the uterine lining. |
| Measure | Description | Time Frame |
|---|---|---|
| Return to perceived regular/normal menstrual cycle | Survey Based Assessment of changes in menstrual cycle | 6 Months |
| Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings | Survey-based assessment of changes in PMS and Menstrual symptoms | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Mitschke | Citruslabs | Principal Investigator |
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| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004412 | Dysmenorrhea |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
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| Placebo Drink | Dietary Supplement | Blended Placebo drink |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |