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A study in real world set up to understand the management of Polycystic Ovarian syndrome with regards to the symptoms and signs of the subjects before and after treatment with Plant based product

Effectiveness of OZiva Plant Based HerBalance PCOS for management of symptoms and signs of polycystic ovarian syndrome in patients visiting Outpatient department: A real world Evidence study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/08/044758
Enrollment
500
Registered
2022-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Zywie Ventures Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Females 15-45 years age with menstrual irregularities, hirsutism and/or infertility related to PCOS 2. Diagnosis of PCOS according to Rotterdam criteria.

Exclusion criteria

Exclusion criteria: 1. Hypothyroidism, 2. Hyperprolactinemia, 3. Cushingâ??s syndrome 4. History of intake of drugs Aldactone/ metformin 5. History of OCP use or intake of drugs known to interfere with carbohydrate metabolism 6. Patients who have consumed any hormonal pills within one month of beginning the study. 7. Patients with critical pre-medical conditions

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of OZiva Plant Based HerBalance PCOS in attenuating menstrual problems, obesity/ difficulty in weight management, infertility related to PCOS, dermatological symptoms/signs related to PCOS like acne, facial hair growth.Timepoint: 45 days -90 days—

Secondary

MeasureTime frame
To evaluate the overall patient satisfaction after completion of therapy with OZiva Plant Based HerBalance PCOS for management of PCOS.Timepoint: 45 days -90 days;To evaluate the safety of OZiva Plant Based HerBalance PCOS for management of PCOS.Timepoint: 45 days-90 days—

Countries

India

Contacts

Public ContactDr Kavita Pingale

Innvocept Global Solutions Private Limited

kavita.pingale@innvoceptsolutions.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026