An interventional study of Elix Daily Harmony and Elix Cycle Balance in Polycystic Ovary Syndrome, sponsored by Zenchi, Inc.. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Zenchi, Inc. · Not applicable, Interventional, and Other
This is a virtual, open-label, 2-armed study that will last 6 months. All participants will take the supplements daily and complete questionnaires at baseline and at the end of weeks 4, 8, 12, 16, 20, and 24 (study may be concluded at week 20 if results are seen earlier). The study will involve 70 participants with polycystic ovary syndrome (PCOS), 35 who are on hormonal birth control, and 35 who are not.
A subgroup of 20 participants from the non-birth control group, who experience hormonal acne/frequent hormonal breakouts will provide photographs of the face for expert skin grading at baseline, week 12, week 20, and week 24 (if the study is continued until week 24).
Questionnaires will be used to monitor changes in the menstrual cycle (regularity, frequency, predictability), bloating, fluid retention, weight gain, mood (mood swings, anxiety, mental clarity/focus, brain fog), pain, fatigue, acne, facial/bodily hair, and sleep quality. Expert skin grading will be carried out by a dermatologist to monitor changes in acne and skin clarity indicative of systemic effects of androgen excess. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Zenchi, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Has experienced at least two of the following:
Exclusion Criteria:
All participants will have a diagnosis of PCOS and be regularly taking hormonal birth control.
Other: Elix Daily Harmony · Other: Elix Cycle Balance
All participants will have a diagnosis of PCOS and must not be taking any hormonal birth control.
Other: Elix Daily Harmony · Other: Elix Cycle Balance
Elix Daily Harmony is a clinical-strength, organic blend of hormone-balancing Traditional Chinese Medicine (TCM) herbs and adaptogens. Contains Angelica Sinensis, licorice, ginger, Bupleurum, Cyperus Rotundus, White Peony, Mint, Poria, Atractylodes, White Ginseng, Reishi, Rehmannia Root, and Astragalus. Participants should add 3 droppers full (half a teaspoon or 2.5 ml) of Elix Daily Harmony to their tea or other warm or room temperature beverage each morning, 1-2 hours after their first meal. The product should not be taken with iced drinks or with food.
A tailored blend of medicinal herbs to holistically support menstrual symptoms by treating underlying imbalances. Participants should take 3 droppers full (half a teaspoon or 2.5 ml) of Elix Cycle Balance daily before bed with tea or other warm or room temperature beverage. The product should not be taken with iced drinks or with food.
To examine the effect of Daily Harmony and Elix Cycle Balance on menstrual cycle regularity and frequency. [Time Frame: Baseline to Week 24]
Menstrual cycle frequency and regularity will be measured via self-reported questionnaire
Time frame: 24 weeks.
To examine the effect of Daily Harmony and Elix Cycle Balance on acne as a symptom of hyperandrogenism. [Time Frame: Baseline to Week 24]
Assessed via self-reported questionnaires using the validated acne quality-of-life scale. Participants will record their score using a 7-point Likert Scale, with 1 representing the most severe symptoms and 7 representing the least severe symptoms.
Time frame: 24 weeks
To examine the effect of Daily Harmony and Elix Cycle Balance on acne measure via expert skin grading. [Time Frame: Baseline to Week 24]
Expert skin grading at baseline and at the end of weeks 12, 20, and 24 will be carried out by a dermatologist and used as a digital biomarker to evaluate improvements in PCOS related skin health (acne/skin clarity).
Time frame: 24 weeks
To examine the effect of Daily Harmony and Elix Cycle Balance on PCOS-associated symptoms. [Time Frame: Baseline to Week 24]
Study-specific surveys will be used to assess the severity and incidence of common PCOS symptoms, including sleep quality bloating/fluid retention, weight gain, fatigue, mood swings, mental clarity/focus/brain fog, anxiety and pain. Participants will record their score using a 5-point Likert Scale, with 1 representing the most negative outcome and 5 representing the best outcome (no symptoms).
Time frame: 24 weeks
Plan to share: Undecided — TBC
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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Zenchi, Inc.