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Effect of Kuntai Capsule on intestinal microecology and insulin resistance in patients with polycystic ovary syndrome: a multicenter, randomized and parallel controlled clinical study

Effect of Kuntai Capsule on intestinal microecology and insulin resistance in patients with polycystic ovary syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079243
Enrollment
Unknown
Registered
2023-12-28
Start date
2022-11-29
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

PCOS

Interventions

Al group:Orally take Kuntai capsule, 4 pills / time, 3 times / day, for three months, non-stop during menstrual time.
A2 group:Orally take Kuntai capsule, 4 pills / time, 3 times / day, for three months, non-stop during menstrual time.
B group:no

Sponsors

Hangzhou Obstetrics and Gynecology Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1Patients meet the diagnostic criteria of the 2003 European Society for Human Reproductive and Embryology in Rotterdam and the American Society of Reproductive Medicine (ESHRE / ASRM), which requires any 2 of the following 3 items: 1) rare ovulation and / or anovulation; 2) clinical manifestations and / or excessive androgens; or 3) ultrasound detection of ovarian polycystic changes: with =12 follicles of 2-9mm in diameter in one /both ovaries,ovarian volume= 10 ml in one /both ovaries;2. Patients are evaluated by the steady-state model insulin resistance index (homeostasis model assessment-insulin resistance index, HOMA-IR), HOMA-IR= 2.69 is regarded as IR, otherwise not IR;3. Women aged between the ages of 18 and 40 years;4. 18=BMI=35 kg/m2;5.Patients have no family planning in recent 3 months;6. Patients are ability to follow the protocol for treatment, examination, and follow-up;7.Patients are consent, voluntary to be tested.

Exclusion criteria

Exclusion criteria: 1. Patients are pregnant or suspected pregnancy;2. Patients have taken drugs that may affect the function or metabolism of the reproductive axis, including oral contraceptives, estrogen, GnRH, antiandrogen drugs, weight-loss drugs, antibiotics and related drugs affecting intestinal flora, such as probiotics,in the past one month;3.Patients with other endocrine disorders, such as diabetes mellitus, congenital adrenal hyperplasia, 21 hydroxylase deficiency, hyperprolactinemia, androgen-secreting tumor, uncorrected thyroid disease, or suspected Cushing syndrome;4.Patients with severe medical diseases, such as liver and renal insufficiency, cardiac insufficiency, severe infection and trauma, hypotension, etc;5.Patients with major surgical histories;6.Patients with hemolytic anemia and G6PD deficiency;7.Patients with mental disorders;8.Patients with allergy to Kuntai capsule;9. Patients who are addicted to tobacco and alcohol.

Design outcomes

Primary

MeasureTime frame
flora analysis in stool samples;blood fat ;

Secondary

MeasureTime frame
sex hormone;Serum glucose;Fasting serum insulin;OGTT;BMI;WHR ;Menstruation scores;acne scores;hirsutism scores;

Countries

China

Contacts

Public ContactZhou Jie

Hangzhou Obstetrics and Gynecology Hospital

793280@163.com+86 135 8830 1922

Outcome results

None listed

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