the effects of berberine combined with metformin on metabolic abnormalities and ovulation in patients with polycystic ovary syndrome: a randomized controlled study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200062984

Enrollment

Unknown

Registered

2022-08-26

Start date

2022-08-27

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

polycystic ovary syndrome

Interventions

Combined group (metformin + berberine):Give metformin 500mg TID orally and berberine 300mg TID orally for three months

Metformin group:Metformin 500mg TID was given orally for three months

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18-40 years old (2) meet the 2003 Rotterdam international standard for the diagnosis of PCOS: ? rare ovulation or anovulation. ? Clinical or biochemical examination indicates hyperandrogenemia. ? Ultrasound indicates ovarian polycystic changes: at least one ovary has = 12 small follicles with a diameter of 2-9mm, and / or the ovarian volume = 10cm3. Meet 2 of the above 3 items, and exclude other diseases (3) 23kg/m2 = body mass index (BMI) < 30 kg/m2 or waist circumference = 85CM (4) HOMA-IR = FPG fasting blood glucose (mmol/l) × Ins fasting insulin (mlu/l) /22.5 = 1.66 (5) sign informed consent and are willing to participate in the study

Exclusion criteria

Exclusion criteria: (1) Diseases of heart, lung, liver, kidney and other important organs (2) acute conditions that may affect renal function: such as dehydration, severe infection, shock (3) trauma, major surgery, clinical hypotension and hypoxia (4) acute metabolic acidosis, diabetes coma prodrome, vitamin B12, folic acid deficiency are not corrected (5) in the last three months, those who have used hormones or taken drugs that affect insulin secretion. (6) Have a history of pregnancy, abortion or childbirth in the last 6 weeks (7) have a history of lactation in the last 6 months. Pregnant or lactating women (8) are allergic to berberine or metformin. Patients with suspected or real history of alcohol and drug abuse (9) hemolytic anemia and glucose-6-phosphate dehydrogenase deficiency

Design outcomes

Secondary

Measure	Time frame
BMI;SBP;DBP;FPG;INS;HbA1C;FSH;LH;LH/FSH;T;FAI;SHBG;TC;TG;ovulation rate;	—

Primary

Measure	Time frame
HOMA-IR;	—

Countries

china

Contacts

Public ContactYu Sha

Shenzhen Second People's Hospital

417799563@qq.com0755-83366388

Outcome results

None listed

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