Polycystic ovary syndrome
Conditions
Interventions
Group A: Low dose Spiritualism formula group:Different doses of Lingshu Formula granules: 1 dose a day once a day. Take it continuously within 3 days after menstruation or progesterone withdrawal blee
Group C: high-dose Lingshu formula granule group:Different doses of Lingshu Formula granules: 1 dose a day, once a day. Take it continuously within 3 days after menstruation or progesterone withdrawal
Group B: medium dose Lingshu formula granule group:Different doses of Lingshu Formula granules: 1 dose a day, once a day. Take it continuously within 3 days after menstruation or progesterone withdraw
Group D: Lingshu decoction group:Lingshu Formula Decoction: 1 dose per day, 100ml/ time, twice a day. Take it continuously within 3 days after menstruation or progesterone withdrawal bleeding, and tak
Sponsors
Ersha Island Hospital of Guangdong Province Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) The Rotterdam criteria for polycystic ovary syndrome were adopted 1) abnormal menstruation such as thin ovulation or anovulation; 2) Clinical manifestations of hyperandrogenemia and/or hyperandrogenemia; 3)PCOM. According to two of the above the diagnosis can be made by excluding other diseases causing ovulation disorders (including thyroid dysfunction premature ovarian failure hypothalamic-pituitary amenorrhea hyperprolactinemia etc.) and diseases causing hyperandrogenemia (including Cushing syndrome atypical adrenogenital syndrome endocrine tumors secreting androgens etc.). If the patient has hyperandrogenemia and rare or anovulatory ovulation ultrasound is not a necessary test. (2) Insulin resistance: The homeostasis model insulin resistance (HOMA-IR) index = (fasting glucose × fasting insulin)/22.5 was calculated. If HOMA-IR index =1.66 was insulin resistance. (3) TCM standard of kidney deficiency phlegm-dampness refers to the relevant standards of kidney-yang deficiency and phlegm-dampness syndrome in Guiding Principles for Clinical Research of New Chinese Medicine (Trial). (4) Aged 18-40 years old; Meet the above diagnostic criteria for PCOS and IR; Voluntary signed informed consent and conditional follow-up.
Exclusion criteria
Exclusion criteria: (1)Subjects with serious primary diseases of cardiovascular liver kidney and hematopoietic systems and psychiatric patients. (2)Subjects with malignant tumors adrenal gland disorders or other diseases causing organ dysfunction. (3)Subjects who have used any hormonal drugs within the past 3 months or had an impact on insulin secretion; those who have participated in other clinical studies within the past month or have been using similar drugs and related treatments within the past month making it difficult to judge the drug's effectiveness. (4)Abnormal liver and kidney function: serum creatinine (Cr) > 133µmol/L; alanine transaminase (ALT) and aspartate transaminase (AST) more than (excluding) twice the upper limit of the normal value; total bilirubin (TBiL) more than (excluding) twice the upper limit of the normal value. (5)Subjects with an allergic constitution allergies to multiple drugs or allergies to the drugs used in this trial. (6)Subjects with a history of alcohol addiction drug abuse or other conditions or situations as determined by the investigator that may reduce the likelihood of enrollment or complicate enrollment such as work environments that frequently change or unstable living environments that may cause loss of follow-up. (7)Subjects who in the opinion of the investigator are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Resistance Index before and after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| prolactin;Luteinizing hormone;Apolipoprotein A;triglyceride;Low-density lipoprotein;TCM symptom evaluation score before and after treatment;Follicle stimulating hormone;Total cholesterol;estradiol;Fasting insulin value;Fasting blood glucose value;progesterone;testosterone;Waist-to-Hip Ratio, WHR;Apolipoprotein B;High density lipoprotein;Size of ovaries under intracavitary B-ultrasound;Body Mass Index (BMI) before and after treatment.; | — |
Countries
China
Contacts
Public ContactLuo Yunyun
Ersha Island Branch of Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed