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Group Two: PCOS with No Hormonal Birth Control for Polycystic Ovary Syndrome
N/A
Waitlist Available
Research Sponsored by Zenchi, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will test supplements (daily) on 70 people with PCOS to monitor changes in menstrual cycle, acne, facial/bodily hair, mood, weight, fatigue, etc. Expert skin grading & Likert scale responses will be used to measure changes.
Who is the study for?
This trial is for women aged 18-36 with PCOS, who are generally healthy and have a stable lifestyle without plans to change their diet, exercise, or hormonal birth control use. Participants must not be pregnant, attempting pregnancy, smokers, or have certain medical conditions like uncontrolled diseases or recent gynecological treatments.Check my eligibility
What is being tested?
The study tests Elix Daily Harmony and Cycle Balance supplements on PCOS symptoms over 6 months. It's virtual and open-label with two groups: one using hormonal birth control and the other not. They'll take daily supplements and complete regular questionnaires about menstrual cycle changes, mood swings, acne etc.See study design
What are the potential side effects?
While specific side effects aren't listed in the provided information for Elix Daily Harmony and Cycle Balance supplements, participants will likely monitor any adverse reactions such as digestive issues or skin irritations through the questionnaires.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To examine the effect of Daily Harmony and Elix Cycle Balance on acne as a symptom of hyperandrogenism. [Time Frame: Baseline to Week 24]
To examine the effect of Daily Harmony and Elix Cycle Balance on acne measure via expert skin grading. [Time Frame: Baseline to Week 24]
To examine the effect of Daily Harmony and Elix Cycle Balance on menstrual cycle regularity and frequency. [Time Frame: Baseline to Week 24]
Secondary outcome measures
To examine the effect of Daily Harmony and Elix Cycle Balance on PCOS-associated symptoms. [Time Frame: Baseline to Week 24]
Trial Design
2Treatment groups
Active Control
Group I: Group Two: PCOS with No Hormonal Birth ControlActive Control2 Interventions
All participants will have a diagnosis of PCOS and must not be taking any hormonal birth control.
Group II: Group One: PCOS & Hormonal Birth ControlActive Control2 Interventions
All participants will have a diagnosis of PCOS and be regularly taking hormonal birth control.
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Who is running the clinical trial?
Zenchi, Inc.Lead Sponsor
2 Previous Clinical Trials
165 Total Patients Enrolled
CitruslabsIndustry Sponsor
68 Previous Clinical Trials
3,775 Total Patients Enrolled
2 Trials studying Polycystic Ovary Syndrome
80 Patients Enrolled for Polycystic Ovary Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a hysterectomy or other major female reproductive surgery in the last 6 months.I experience symptoms like mood swings, irregular periods, and low energy.I have been on the same hormonal birth control for 3 months and won't change it for the next 6 months.I have been diagnosed with a specific chronic condition or cancer related to my reproductive or digestive system, or an autoimmune disorder.I am generally healthy without any uncontrolled chronic diseases.I haven't changed my hormonal birth control recently and don't plan to change it soon.My kidney or liver tests are not more than twice the normal limit.I haven't started any new medication or supplements for weight, skin, mood, or menstrual cycle in the last 3 months.I experience frequent acne breakouts, possibly due to hormone issues.My BMI is over 35.I have not used hormonal birth control in the last 3 months and don't plan to start in the next 6 months.I do not have any unstable or uncontrolled health or mental conditions.I haven't used hormonal birth control for 3 months and won't use it for the next 6 months.I use medications or supplements that affect my menstrual cycle.I am a woman aged between 18 and 36.I was diagnosed with PCOS within the last 5 years.I agree not to take any supplements affecting my menstrual cycle during the study.I can follow the study rules, take supplements on time, complete surveys online, and share photos if needed.I am not pregnant, breastfeeding, or trying to get pregnant.I have had at least two symptoms like irregular periods, excessive hair, acne, or diagnosed with polycystic ovaries.I have PCOS diagnosed by ultrasound or pelvic exam, with or without irregular periods.
Research Study Groups:
This trial has the following groups:- Group 1: Group Two: PCOS with No Hormonal Birth Control
- Group 2: Group One: PCOS & Hormonal Birth Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current research endeavor enlisting seniors aged 70 or older?
"This medical trial is suitable for individuals aged 18 to 36."
Answered by AI
Is there currently an open enrollment period for this experiment?
"Clinicaltrials.gov affirms that this investigation is currently in search of suitable participants, which it first advertised on April 13th 2023 and subsequently updated on May 15th 2023."
Answered by AI
How many participants are engaged in the research endeavor?
"Confirmed. Evidence on clinicaltrials.gov indicates that this scientific experiment is actively enrolling participants, having initially been posted on April 13th 2023 and last revised on May 15th 2023. The research seeks 70 individuals from a single site."
Answered by AI
Am I eligible to be a participant in this research project?
"This study is looking to enrol up to 70 people suffering from polycystic ovary syndrome who are aged between 18 and 36."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Citruslabs
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I’ve tried many holistic methods to treat PCOS and have not been able to get it under control.
PatientReceived 2+ prior treatments
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