polycystic ovarian syndrome
Conditions
Interventions
Spleen deficiency phlegm-dampness group:None
Kidney deficiency and liver depression group:None
Healthy group:None
Sponsors
Xiamen University First Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for PCOS patients 1. All patients have signed the informed consent form. 2. Meet the following diagnostic criteria of both traditional Chinese medicine and Western medicine. 2.1 Diagnostic criteria of traditional Chinese medicine: The diagnostic criteria for TCM syndrome types are formulated based on the "Guidelines for Integrated Diagnosis and Treatment of Polycystic Ovary Syndrome (2023 Edition)" "Gynecology of Traditional Chinese Medicine" previous literature research and the clinical experience of the supervisor. The tongue diagnosis of TCM refers to the tongue diagnosis standards in "Diagnosis of Traditional Chinese Medicine" to observe and interpret the tongue appearance which includes tongue color tongue shape coating texture and coating color. 2.1.1 Syndrome of Spleen Deficiency and Phlegm Dampness Chief symptoms: Delayed menstruation or amenorrhea overweight or obesity and infertility after marriage. Secondary symptoms: Excessive vaginal discharge dizziness chest tightness limb fatigue abdominal distension sticky mouth loss of appetite loose stools. Tongue appearance: Pale or dark tongue color enlarged tongue body with tooth marks on the edge white or yellow coating thick and greasy coating. Pulse: Deep fine and slippery. 2.1.2 Syndrome of Kidney Deficiency and Liver Depression Chief symptoms: Oligomenorrhea or amenorrhea hirsutism or acne and infertility after marriage. Secondary symptoms: Scanty vaginal discharge dizziness tinnitus soreness and weakness of the waist and knees depression or irritability belching and sighing breast distension before menstruation. Tongue appearance: Pale or dark red tongue color purple lines on the edge white or yellow coating thin and greasy coating. Pulse: Fine and taut. If two or more chief symptoms and three or more secondary symptoms are present combined with tongue and pulse the diagnosis can be made. 2.2 Diagnostic criteria of Western medicine: Refer to the 2023 International Evidence-Based Guidelines for the Evaluation and Management of Polycystic Ovary Syndrome. Diagnosis can be made if two of the following three conditions are met: 1) Oligoovulation or anovulation; 2) Clinical and/or biochemical hyperandrogenism using the FG score for clinical hyperandrogenism with a score > 5 considered as clinical hyperandrogenism; 3) Polycystic ovarian morphology on ultrasound accompanied by elevated AMH levels and excluding thyroid disease hyperprolactinemia atypical congenital adrenal hyperplasia hypogonadotropic hypogonadism Cushing's disease or suspected androgen-producing tumors etc. 3. Women aged between 18 and 45 years old. Inclusion Criteria for the Healthy Group: 1.Enrolled participants have signed the informed consent form. 2Healthy volunteers undergoing physical examination in the physical examination center during the same period are selected, with no obvious constitutional bias identified by traditional Chinese medicine (TCM) syndrome differentiation. 3.Female participants aged between 18 and 45 years old.
Exclusion criteria
Exclusion criteria: Those with any of the following circumstances will not be included as selected cases: 1.Ultrasound examination suggests abnormal endometrial lesions or uterine malformations uterine fibroids and adnexal masses 2.Combined with cardiac function grades III - IV Child-Pugh score grades B - C serum creatinine greater than 1.5mg/dl AGI grades I - IV and blood picture indication: absolute value of neutrophils < 0.5×109/LThe absolute value of reticulocytes is less than 60×109/L. Bone marrow cell proliferation Patients with severe primary diseases such as heart liver kidney gastrointestinal and hematopoietic functions with a degree less than 25% of normal 3. Patients with concurrent mental disorders 4. Those who have taken antibiotics within the past month 5.Patients with local lesions in the tongue mouth nose pharynx etc. within the past month 6.Rule out factors such as smoking drug exposure or food contamination 7.Those who are currently participating in other clinical trials.Those with any of the following circumstances will not be included as selected cases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ProlactinPRL;Modified polycystic ovary syndrome health-related quality-of-life questionnaire MPCOSQ;Follicle-stimulating hormoneFSH;EstradiolE2;Luteinizing hormoneLH;ProgesteronePRGE;TestosteroneT; | — |
Secondary
| Measure | Time frame |
|---|---|
| CreatinineCRE;High-density lipoproteinHDL-C;?-Glutamyl transferase?-GT;Fasting blood glucose FBG;Alanine aminotransferaseALT;TriglycerideTG;Fasting insulinFINS;PCOS TCM Syndrome Grading Scale;Uric acidUA;Aspartate aminotransferaseAST;Total cholesterolTCHO;Low-density lipoproteinLDL-C;Blood Urea NitrogenBUN;Gynecological Color Doppler US; | — |
Countries
China
Contacts
Public ContactChen Xueqin
Xiamen University First Affiliated Hospital
Outcome results
None listed