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Chinese medicine sequential therapy for polycystic ovary syndrome of spleen-kidney-yang deficiency phlegm-dampness infertility: a randomized controlled clinical study

Chinese medicine sequential therapy for polycystic ovary syndrome of spleen-kidney-yang deficiency phlegm-dampness infertility: a randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000239
Enrollment
Unknown
Registered
2024-08-15
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Polycystic ovarian syndrome

Interventions

metformin+Chinese medicine placebo:metformin+Chinese medicine placebo
metformin+Chinese medicine sequential treatment:metformin+Chinese medicine sequential treatment

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria of Rotterdam PCOS: 1) dilute ovulation or anovulation; Hyperandrogenemia and/or clinical manifestations of hyperandrogenism, such as hypertrichosis, acne, acanthosis nigricans, etc.; (3) polycystic ovarian changes: at least one ovarian follicle with a diameter of 2~9mm =12, and (or) ovarian volume > 10mL. PCOS can be diagnosed if two of these conditions are met and other diseases that may cause hyperandrogen are excluded. 2) In line with traditional Chinese medicine spleen kidney Yang deficiency phlegm-dampness diagnostic criteria: waist and knees weak, fatigue and cold, thin loose stool, dizziness chest tightness, limb fatigue, lethargy; The amount under the band is too much; Pale and fat tongue, white and greasy fur, deep and smooth pulse; 3) Normal sexual life after marriage for more than 1 year without pregnancy, existing pregnancy intention; 4) Han women aged between 20 and 35; 5) The patient agrees to accept the treatment method of the group and signs the informed consent.

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions were excluded. 1) Oral contraceptives, glucocorticoids, anti-estrogen drugs, ovulation stimulating agents, diabetes drugs or other steroid drugs within 3 months; 2) Patients who are pregnant or breastfeeding; 3) Patients with serious primary diseases of the heart, liver, lung, kidney, brain or blood system, or with mental illness; 4) Endocrine disorders caused by other primary diseases, such as adrenal hyperplasia, hyperprolactinemia, thyroid diseases or tumors; 5) Serious adverse reactions to the drugs in this study; 6) Patients who are participating in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
clinical pregnancy rate;

Secondary

MeasureTime frame
live birth rate;HDL;menstrual cycle;Zung-SAS/Zung-SDS;insulin release test;Triglycerides;TCM symptom score;glucose tolerance test;SF-36;ongoing pregnancy rate;Total cholesterol;LDL;

Countries

China

Contacts

Public ContactZhang mingmin

Tongji hospital, Tongji medical college, Huazhong university of science and technology

mmzhangeins@163.com13995675011

Outcome results

None listed

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