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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMS Capsule Group | Experimental | Participants in this arm will take the PMS capsule, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Boswellia, Milk Thistle Extract, Resveratrol, and Ashwagandha. |
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| Capsule Placebo Group | Placebo Comparator | Participants in this arm will take a placebo capsule, containing microcrystalline cellulose and other inert ingredients. |
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| PMS Gummy Group | Experimental | Participants in this arm will take the PMS gummy, which contains Vitamin D3, Magnesium, Quercetin, Curcumin, Lemon Balm Extract, Milk Thistle Extract, and Resveratrol. |
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| Gummy Placebo Group | Placebo Comparator | Participants in this arm will take a placebo gummy, containing inert ingredients such as tapioca syrup, cane sugar, and citric acid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMS Capsule | Dietary Supplement | Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Premenstrual Syndrome (PMS) Symptom Severity | Evaluate the effectiveness of the PMS capsule and gummy in alleviating symptoms associated with PMS, using the validated Menstrual Symptom Questionnaire (MSQ). The MSQ assesses 24 symptoms with scores ranging from 1 (never) to 5 (always), where a higher score indicates greater symptom severity. | From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Perception of PMS Symptom Relief | Assess participants' subjective perception of symptom relief provided by the PMS capsule and gummy, using a custom survey with questions related to satisfaction, effectiveness, and tolerability. | From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline) |
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Inclusion Criteria:
Menstrual pain, Menstrual cramping, Increased Irritability, Mood changes, Breast tenderness, Headaches/migraines, Bloating, Fatigue, Constipation or diarrhea, Sleep disturbances
Exclusion Criteria:
Participants will self-report that they are not pregnant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
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| Capsule Placebo | Dietary Supplement | Participants will take 2 capsules, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. |
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| PMS Gummy | Dietary Supplement | Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. |
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| Gummy Placebo | Dietary Supplement | Participants will take 2 gummies, 4 times daily, starting at the onset of PMS symptoms and continuing until symptoms subside. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D005221 | Fatigue |
| D006261 | Headache |
| D008881 | Migraine Disorders |
| D003248 | Constipation |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D013050 | Spectrometry, Fluorescence |
| ID | Term |
|---|---|
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
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