Health Condition 1: N830- Follicular cyst of ovary
Conditions
Interventions
Intervention1: Zury Innovation: Daily measurement of study parameters using Zury Innovation application for 90 days
Control Intervention1: Standard of care: Subjects will follow standard of care and
Sponsors
Cinta Medtech
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries. 2.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 3.Subject willing to adhere with the routine diet, physical activity, and general lifestyle as per the protocol requirement throughout the study 4.Ability to understand and willingness to comply with the study protocol 5.Should be able to enter data in a mobile app and have basic English reading capabilities 6.Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.PCOS patients who are currently pregnant or have recently given birth in the past 3 months. 2.History of clinically significant illness or any other medical disorder (known renal and liver disorders) that may interfere with subject treatment, assessment or compliance with the protocol. 3.Subjects with lean PCOS 4.Subjectâ??s Body mass index (BMI) is les than 18 and weight is less than 50kg 5.Subjects with history of Psychiatric disorders on medication and Alcohol or drug abuse 6.Known HIV or Hepatitis B positive or any other immuno-compromised state 7.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight and anthropometric parametersTimepoint: Day 0, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in psychological and quality of life impactTimepoint: Day 0, Day 30, Day 60, Day 90;Changes in body composition parametersTimepoint: Day 0, Day 30, Day 60, Day 90;Changes in food and nutrition related choicesTimepoint: Day 0, Day 30, Day 60, Day 90;Changes in PCOS Related assessment parametersTimepoint: Day 0, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactJestin V thomas
Divakars Speciality Hospital
Outcome results
None listed