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Effects of Fuke Zaizao Pill(Capsule) combined with progesterone in the treatment of polycystic ovary syndrome: a study protocol for a multi-center, randomized controlled clinical trial

Effects of Fuke Zaizao Pill(Capsule) combined with progesterone in the treatment of polycystic ovary syndrome: a study protocol for a multi-center, randomized controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066957
Enrollment
Unknown
Registered
2022-12-22
Start date
2023-01-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Polycystic ovary syndrome

Interventions

Intervention group:Fuke Zaizao Pill (Capsule) combined with progesterone

Sponsors

Women's Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-45 years old, menstruating for more than two years; 2. Meet PCOS diagnostic criteria; 3.Contraception for 3 months during the medication period; 4.Agree to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants who have been recently taking similar drugs that regulate menstruation or have participated in any other clinical trials in the past 1?months, making it difficult to evaluate the effects of the present interventions; 2. Participants with severe primary diseases of cardiovascular,cerebrovascular, hepatic, renal, hematopoietic system or diabetes, thyroid disease, tumor or severe mental disorder; 3. Unexplained vaginal bleeding; 4. Pregnant or breast-feeding women; 5. Subjects with the serum levels of creatinine or alanine aminotransferase or aspartate aminotransferase more than the normal levels; 6. Researchers consider it inappropriate for the subject to complete the study.

Design outcomes

Secondary

MeasureTime frame
Size of body parts(weight, waist circumference, hip circumference);Clinical pregnancy;

Primary

MeasureTime frame
Menstrual;Quality of life;

Countries

China

Contacts

Public ContactFan Qu

Women's Hospital, School of Medicine, Zhejiang University

syqufan@zju.edu.cn+86 134 2911 9143

Outcome results

None listed

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