search
Back to results

A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elix Daily Harmony
Elix Cycle Balance
Sponsored by
Zenchi, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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. 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.

Sites / Locations

  • CitruslabsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group One: PCOS & Hormonal Birth Control

Group Two: PCOS with No Hormonal Birth Control

Arm Description

All participants will have a diagnosis of PCOS and be regularly taking hormonal birth control.

All participants will have a diagnosis of PCOS and must not be taking any hormonal birth control.

Outcomes

Primary Outcome Measures

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
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.
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).

Secondary Outcome Measures

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).

Full Information

First Posted
April 19, 2023
Last Updated
August 5, 2023
Sponsor
Zenchi, Inc.
Collaborators
Citruslabs
search

1. Study Identification

Unique Protocol Identification Number
NCT05875233
Brief Title
A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
Official Title
An Open-Label, 2-armed Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zenchi, Inc.
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group One: PCOS & Hormonal Birth Control
Arm Type
Active Comparator
Arm Description
All participants will have a diagnosis of PCOS and be regularly taking hormonal birth control.
Arm Title
Group Two: PCOS with No Hormonal Birth Control
Arm Type
Active Comparator
Arm Description
All participants will have a diagnosis of PCOS and must not be taking any hormonal birth control.
Intervention Type
Other
Intervention Name(s)
Elix Daily Harmony
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Elix Cycle Balance
Intervention 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.
Primary Outcome Measure Information:
Title
To examine the effect of Daily Harmony and Elix Cycle Balance on menstrual cycle regularity and frequency. [Time Frame: Baseline to Week 24]
Description
Menstrual cycle frequency and regularity will be measured via self-reported questionnaire
Time Frame
24 weeks.
Title
To examine the effect of Daily Harmony and Elix Cycle Balance on acne as a symptom of hyperandrogenism. [Time Frame: Baseline to Week 24]
Description
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
Title
To examine the effect of Daily Harmony and Elix Cycle Balance on acne measure via expert skin grading. [Time Frame: Baseline to Week 24]
Description
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
Secondary Outcome Measure Information:
Title
To examine the effect of Daily Harmony and Elix Cycle Balance on PCOS-associated symptoms. [Time Frame: Baseline to Week 24]
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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.
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Renner, MSc
Phone
424-245-0285
Email
hello@citruslabs.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
TBC

Learn more about this trial

A Study to Evaluate the Effect of Elix Cycle Balance and Daily Harmony on Polycystic Ovary Syndrome

We'll reach out to this number within 24 hrs