Trial Title:
A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
NCT ID:
NCT05875233
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Factorial Assignment
Intervention model description:
Population will be split into 2 arms of 35 participants each: 1 group who are on hormonal
birth control, and 1 group who are not on hormonal birth control. All participants will
take the test product.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Elix Daily Harmony
Description:
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.
Arm group label:
Group One: PCOS & Hormonal Birth Control
Arm group label:
Group Two: PCOS with No Hormonal Birth Control
Intervention type:
Other
Intervention name:
Elix Cycle Balance
Description:
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.
Arm group label:
Group One: PCOS & Hormonal Birth Control
Arm group label:
Group Two: PCOS with No Hormonal Birth Control
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female aged 18-36
- Diagnosed with PCOS in the last 5 years.
- Has experienced at least two of the following:
1. Irregular menstrual periods or the absence of menstrual periods.
2. Excessive facial or body hair, thinning hair, or hair loss on the scalp, oily
skin, and or acne.
3. Polycystic ovaries as determined by ultrasound.
- Otherwise generally healthy (not living with any uncontrolled chronic disease)
- Has concerns about irregular menstrual cycles and ovulation, mood swings, stress,
tender breasts, food cravings, irritability, or low energy.
- Following stable, consistent diet and exercise regimens, and willing to refrain from
making any lifestyle changes that may affect their menstrual cycle for the duration
of the study.
- Willing to refrain from taking any other supplements that may target the menstrual
cycle throughout the study period.
- Willing and able to adhere to the study protocol, including taking supplements at
the required times, completing questionnaires via the technology portal, and where
appropriate sharing the required photographs.
- Able to communicate in English.
- Participants must provide written informed consent (ICF).
- For the hormonal birth control group: must have been on the same hormonal birth
control for the past 3 months and be willing to not make any changes to their
hormonal birth control for the next 6 months.
- For the non-hormonal birth control group: must have been off hormonal birth control
for the past 3 months and be willing to stay off hormonal birth control for the next
6 months.
- For the non-hormonal birth control group: Experience hormonal acne or frequent acne
breakouts (a symptom of androgen excess).
Exclusion Criteria:
- Any pre-existing, unstable or uncontrolled medical or psychiatric illness.
- Anyone who has been diagnosed with endometriosis, uterine fibroids, pelvic
inflammatory disease, reproductive cancers, chronic liver disease, diverticular
disease, colorectal cancer or previous history of colorectal cancer, chronic
pancreatitis, adenomyosis, fibromyalgia, rheumatoid arthiritis, lupus, inflammatory
bowel disease, diagnosed chronic uncontrolled migraines, chronic pelvic pain
syndrome, multiple sclerosis, chronic fatigue syndrome.
- Anyone who has undergone a hysterectomy, bilateral salpingo-oophorectomy, or any
other gynecological medical or surgical treatment in the past 6 months.
- Anyone with significant abnormalities in the physical or laboratory examination.
This includes having renal or liver function more than twice the normal range.
- Anyone with known severe allergic reactions that require the use of an epi-pen, or
anyone who has any known allergy to any of the test product ingredients.
- Women who are pregnant, breastfeeding or attempting to become pregnant.
- Unwilling or unable to follow the study protocol.
- Users of any medication, herbal remedy, or supplement that can affect the menstrual
cycle, or anyone who has used Elix Daily Harmony or Cycle Balance in the past.
- Anyone who has introduced a new medication, supplement or herbal remedies that
target weight, skin (acne), mood, or menstrual cycle, in the last 3 months.
- Smokers, or anyone who has smoked in the past 6 months.
- Anyone with a history of substance abuse.
- Anyone who has more than 3 alcoholic drinks per day.
- Anyone with a BMI >35.
- For the hormonal birth control group: anyone who has changed their hormonal birth
control in the past 3 months, or who is planning to change it in the next 6 months.
- For the non-hormonal birth control group: anyone who has been on hormonal birth
control for the past 3 months, or who is planning to start using hormonal birth
control in the next 6 months.
Gender:
Female
Minimum age:
18 Years
Maximum age:
36 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Citruslabs
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Start date:
April 13, 2023
Completion date:
August 30, 2024
Lead sponsor:
Agency:
Zenchi, Inc.
Agency class:
Industry
Collaborator:
Agency:
Citruslabs
Agency class:
Industry
Source:
Zenchi, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05875233
