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Based on the follicle-granulosa cell metabolic pathway to explore the effects of zaoshi-phlegm-reducing Traditional Chinese medicine on the developmental potential and energy metabolism of phlegm-dampness PCOS oocytes

Based on the follicle-granulosa cell metabolic pathway to explore the effects of zaoshi-phlegm-reducing Traditional Chinese medicine on the developmental potential and energy metabolism of phlegm-dampness PCOS oocytes

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053691
Enrollment
Unknown
Registered
2021-11-27
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Polycystic ovarian syndrome

Interventions

Test group:particles
Control group:No

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Married women aged 35-45 years old; in line with the diagnosis of this disease in Western medicine and the standard of TCM phlegm-damp syndrome differentiation; 2. Diagnostic criteria for polycystic ovary syndrome: (1) The Gynecological Endocrinology Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association formulated the 2011 "China PCOS Diagnostic Criteria": amenorrhea or oligomenorrhea or irregular uterine bleeding are necessary criteria, and at least one of the following can be diagnosed as suspected PCOS: Clinical manifestations of hyperandrogenism or hyperandrogenemia; ultrasound suggests polycystic ovary (more than 12 follicles with a diameter of 0.2-0.9 cm in at least one ovary, or ovarian volume greater than or equal to 10 cm3). Suspected PCOS patients must exclude other disorders that may trigger ovulatory disorders and hyperandrogenism before diagnosis. Compared with the international standard, the Chinese PCOS diagnostic criteria emphasizes the pathological role of ovarian dysfunction, and is more suitable for the actual situation of Chinese women; (2) Syndrome differentiation of phlegm-damp polycystic ovary syndrome: formulate with reference to the "People's Republic of China Traditional Chinese Medicine Industry Standard - TCM Disease Diagnosis and Efficacy Standard" and the seventh edition of the national textbook "Traditional Chinese Medicine Gynecology". Main symptoms: infertility after long-term marriage; late menstruation, or gradually amenorrhea; menstrual flow is light, and the color is light red. Concurrent symptoms: obesity; chest tightness and nausea; excessive vaginal discharge and sticky discharge; loose stools or menstrual diarrhea. Tongue pulse: The tongue is pale and greasy, and the pulse is weak. The above three main syndromes are necessary, and the diagnosis can be made with 1-2 concurrent syndromes. Tongue pulse is the reference.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal endocrine functions such as adrenal gland, thyroid gland, pituitary gland, such as adrenal hyperplasia, adrenal insufficiency, hyperthyroidism, hypothyroidism, pituitary tumor, Sheehan's syndrome, diabetes, etc.; 2. Patients with cardiovascular and cerebrovascular diseases, such as hypertension, coronary heart disease, etc.; patients with liver and kidney diseases; patients with neurological and mental diseases; patients with blood diseases; 3. Patients with acute genitourinary system inflammation; patients with reproductive system tumors; 4. Patients with organic lesions of reproductive organs; patients taking contraceptives or other hormone-containing drugs within three months; patients with late physiological menstruation and amenorrhea; patients with poor compliance.

Design outcomes

Primary

MeasureTime frame
Oocyte mass;

Countries

China

Contacts

Public ContactZhao Shuai

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

xiao-xue0531@163.com+86 531 68617766

Outcome results

None listed

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