Application of Zury Innovation (digital therapeutics) in the management of Polycystic ovary syndrome (PCOS) in Indian women.
- Conditions
- Health Condition 1: N830- Follicular cyst of ovary
- Registration Number
- CTRI/2021/06/034241
- Lead Sponsor
- Cinta Medtech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method