Clinical study on the treatment of overweight/ obese polycystic ovary syndrome (PCOS) by tonifying kidney, resolving phlegm and removing blood stasis combined with Metformin

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086002

Enrollment

Unknown

Registered

2024-06-24

Start date

2024-07-01

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:Chinese medicine for tonifying kidney, resolving phlegm and removing blood stasis combined with Metformin

Control Group:Chinese medicine placebo for tonifying kidney, resolving phlegm and removing blood stasis combined with Metformin

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.According to the diagnostic standard of Western medicine PCOS, TCM syndrome differentiation standard of phlegm-dampness block; 2.BMI>=24kg/m2; 3.Ages 18-40(including 18 and 40); 4.Agree to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with androgen-secreting tumors, congenital adrenal cortex hyperplasia, and Cushing syndrome; 2.Patients using medications related to diseases such as insulin-dependent diabetes, Crohn's disease, leiomyoma, thyroid disorders, liver conditions, heart disease, chronic diarrhea, ulcerative colitis, rheumatoid arthritis, systemic lupus erythematosus, and cancer; 3.Patients with organic diseases such as congenital gonadal dysgenesis, tubal obstruction, and genital tract malformations; 4.Patients with cardiac, hepatic and renal insufficiency; 5.Persons with mental illness; 6.Pregnant or lactating women; 7.Participants in similar studies in the past three months.

Design outcomes

Primary

Measure	Time frame
Ovulation rate;	—

Secondary

Measure	Time frame
TCM Syndrome scoring form;Ferriman-gallwey hirsutism rating scale;Acne Pillsbury Rating Scale;Black acanthosis scoring criteria;Sex Hormones;Fasting Blood Glucose;Fasting Insulin;Insulin Resistance Index;Fasting Blood Lipids;25-OH-VitD;Ferritin;Blood routine test;Urine routine;Liver function;Renal function;electrocardiogram;	—

Countries

China

Contacts

Public ContactYang Cao

Yueyang Hospital of Integrated Chinese and Western medicine, Shanghai University of Traditional Chinese medicine

cindy8813966@126.com+86 137 6429 3960

Outcome results

None listed

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