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EnBrace HR for Premenstrual Syndrome (PMS) With Prominent Mood Symptoms (or Menstrual Related Mood Disorders, MRMD)
The purpose of this study is to assess a novel nutritional supplement developed for prenatal health and mood benefits, and to determine whether there is preliminary evidence for efficacy in Menstrual Related Mood Disorders (MRMD), including PMS with Prominent Mood Symptoms and PMDD.
Details
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 4 |
| Status | WITHDRAWN |
| Start date | 2019-11 |
| Completion | 2022-11 |
Conditions
- Premenstrual Syndrome
- Premenstrual Dysphoric Disorder
- Premenstrual Tension
- Menstrual Related Mood Disorder
Interventions
- EnBrace HR Softgel
Primary outcomes
- Rate of Treatment Response to EnBrace Therapy Measured Using The Daily Record of Severity of Problems (DRSP) — Assessed daily for 8 weeks of treatment
Experience a response (50% improvement in MRMD symptoms) to EnBrace therapy, as assessed by the DRSP (≥ 50% decrease in DRSP score during the luteal phase). The DSRP involves daily rating of scale items and ranking based on severity for each day of the menstrual cycle. The DRSP includes 21 symptom items grouped within 11 domains. An individual records the score for each item on each day using the following scale of 1 to 6: 1=not at all, 2=minimal, 3=mild, 4=moderate, 5=severe, 6=extreme. Clinically significant MRMD symptoms are defined as a ≥ 30% increase in the total DRSP score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding).
Countries
United States