Polycystic Ovary SyndromeNCT05875233
A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
A study testing Elix Daily Harmony and Elix Cycle Balance in people with Polycystic Ovary Syndrome, run by Zenchi, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Elix Daily Harmony and Elix Cycle Balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female aged 18-36
- Diagnosed with PCOS in the last 5 years.
- Has experienced at least two of the following:
- Irregular menstrual periods or the absence of menstrual periods.
- Excessive facial or body hair, thinning hair, or hair loss on the scalp, oily skin, and or acne.
- Polycystic ovaries as determined by ultrasound.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, 2-armed Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Elix Daily Harmony, Elix Cycle Balance
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elix Daily HarmonyOther
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.
Elix Cycle BalanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group One: PCOS & Hormonal Birth Control | Active comparator | All participants will have a diagnosis of PCOS and be regularly taking hormonal birth control. Receives: Other: Elix Daily Harmony; Other: Elix Cycle Balance |
| Group Two: PCOS with No Hormonal Birth Control | Active comparator | All participants will have a diagnosis of PCOS and must not be taking any hormonal birth control. Receives: Other: Elix Daily Harmony; Other: Elix Cycle Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 24 weeks
Secondary outcomes (1)
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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start13 Apr 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zenchi, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875233
- Sponsor's protocol ID
- 20318
- Status last verified
- Jul 2024
- First submitted
- 19 Apr 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: TBC
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 2-armed Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05875233
- Acronym / sponsor ID
- 20318
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zenchi, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group One: PCOS & Hormonal Birth Control | Active comparator | Other: Elix Daily Harmony, Other: Elix Cycle BalanceAll participants will have a diagnosis of PCOS and be regularly taking hormonal birth control. |
| Group Two: PCOS with No Hormonal Birth Control | Active comparator | Other: Elix Daily Harmony, Other: Elix Cycle BalanceAll participants will have a diagnosis of PCOS and must not be taking any hormonal birth control. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Female aged 18-36
- Diagnosed with PCOS in the last 5 years.
- Has experienced at least two of the following:
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elix Daily HarmonyElix 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. | Other | Group One: PCOS & Hormonal Birth Control, Group Two: PCOS with No Hormonal Birth Control |
| Elix Cycle BalanceA 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. | Other | Group One: PCOS & Hormonal Birth Control, Group Two: PCOS with No Hormonal Birth Control |
Primary outcome
To examine the effect of Daily Harmony and Elix Cycle Balance on menstrual cycle regularity and frequency. [Time Frame: Baseline to Week 24]
Time frame: 24 weeks.
Menstrual cycle frequency and regularity will be measured via self-reported questionnaire
To examine the effect of Daily Harmony and Elix Cycle Balance on acne as a symptom of hyperandrogenism. [Time Frame: Baseline to Week 24]
Time frame: 24 weeks
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.
To examine the effect of Daily Harmony and Elix Cycle Balance on acne measure via expert skin grading. [Time Frame: Baseline to Week 24]
Time frame: 24 weeks
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).
1 secondary outcome
To examine the effect of Daily Harmony and Elix Cycle Balance on PCOS-associated symptoms. [Time Frame: Baseline to Week 24]
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided. TBC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elix Daily Harmony and Elix Cycle Balance in people with Polycystic Ovary Syndrome, run by Zenchi, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the effect of Daily Harmony and Elix Cycle Balance on menstrual cycle regularity and frequency. [Time Frame: Baseline to Week 24] (time frame: 24 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.