Polycystic Ovary Syndrome
Conditions
Interventions
The treatment group:Take ZiShenXieHuoHuaYuLiShi Fang
The control group:Take the placebo medicine
Sponsors
Affiliated Hospital, Jiangxi University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age of women between 20 and 40 years; 2. According to the Rotterdam criteria , all participating women had ovulatory dysfunction combined with hyperandrogenism (on the basis of hirsutism 9 or an elevated testosterone level 10), polycystic ovaries (defined by an increased number of small antral follicles (more than 12 follicles that were less than 10 mm in diameter) or an increased individual ovarian volume (more than 10 cm 3) in more than 1 ovary), or both; 3. Patients willing to accept the treatment provisions of this subject; Attached: diagnosis criteria: According to the modified Rotterdam criteria Chinese women can be diagnosed with PCOS in the following conditions: characterized with chronic oligomenorrhea or amenorrhea as the first necessary symptoms, or complicated by other symptoms of (1) polycystic ovaries (defined by an increased number of small antral follicles (greater than 12 follicles that were less than 9 mm in diameter or an increased individual ovarian volume (larger than 10 cm 3) in more than 1 ovary); (2) hyperandrogenism (on the basis of hirsutism 9 or an elevated testosterone. level 10); Oligomenorrhea is defined as an intrmenstrual interval longer than 35 days or less than 8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval longer than 90 days. Hirsutism is determined by a modified Ferriman-Gallwey Score more than 5 at screening examination. PCOS patients with chronic oligomenorrhea or amenorrhea take vaginal ultrasound examination any day in a menstrual cycle or on an early follicular phase of first 2-5 days of the cycle. Transvaginal ultrasound examination will be done by a transvaginal probe. Following items are usually included in the check list: size of the uterus, leiomyoma possibility and its size, other abnormal performance of uterus, endometrial thickness, ovary size in three dimensional space, diameter of the largest follicle, the follicle count in the largest plane and the configuration of follicle. The Ovary size is measured by the two maximum planes of the two spatial dimensions and the third rate by rotating the vaginal probe at a 90 degree angle. Endometrial thickness is the largest of the measured values between the front and back sagittal plane of the uterus. Ovarian volume is determined by calculating long oblate ellipsoid formula (length*width*height*3.14/6). The volume of Polycystic ovary is diagnosticing according to Rotterdam criteria, namely, at least on one side of the ovarian volume more than 10 cm3, and without cyst or follicle diameter more than 10 mm, and also in the same section of polycystic ovarian follicle number more than 12.
Exclusion criteria
Exclusion criteria: 1. Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart more than 20ng/mL). The purpose of ruled-out patients with hyperprolactinemia is to reduce the differences of PCOS subjects. These patients may apply to other treatment methods (Such as dopamine agonists). Those whose test value is normal in the past year or are receiving treatment can be adequate to enter the group; 2. Patients with FSH levels more than 15mIU/mL. A normal level within the last year is adequate for entry; 3. Patients with uncorrected thyroid disease (defined as TSH less than 0.2mIU/mL or more than 5.5mIU/mL). A normal level within the last year is adequate for entry; 4. Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as HbA1c level more than 7.0%), or patients receiving antidiabetic medications such as metformin, insulin, thiazolidinediones, acarbose, or sulfonylureas. In order to diagnosis is Type I or Type II diabetes, or pcos Patients are receiving metformin treatment also should be rule out; 5. Patients with suspected Cushing's syndrome; 6. Use of hormonal or other medication including Chinese herbal prescriptions in the past 3 months; 7. Pregnancy within the past 6 weeks; 8. Within 6 weeks postabortion or postpartum; 9. Breastfeeding within the last 6 months; 10. Not willing to give written consent to the study; Specific exclusion criteria: 1. Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two-month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants,especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins; 2. Patients with liver disease defined as AST or ALT more than normal 2 times or total bilirubin more than 2.5mg/dL. Patients with renal disease defined as BUN more than 30mg/dL or serum serum creatinine more than 1.4mg/dL; 3. Patients with hemoglobin less than 10g/dL; 4. Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; 5. Patients with a current history of alcohol abuse. Alcohol abuse is defined as more than 14 drinks/week or binge drinking; 6. Patients who anticipate taking longer than a one-month break during the protocol should not be enrolled; 7. Patients taking other medications known to affect reproductive function or metabolism. These medications include oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, antiobesity drugs, Chinese herbal formula, antidiabeteic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, angiotensin-converting-enzyme (ACE) inhibitors,and calcium channel blockers. The washout period on all these medications will be two months; 8. Patients with a suspected adrenal or ovarian tumor secreting androgens; 9. Patients with untreated poorly controlled hypertension defined as a systolic blood pressure 160mmHg or a diastolic 100mm Hg obtained on two measures obtained at least 60 minutes apart; 10. Patients with known congenital adrenal hyperplasia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of women with at least once ovulation in each group during the study period;The ovulation rate during the study period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body mass index (BMI);Ferriman-Gallwey hirsutism score;Acne score;Insulin releasing test;Sex determination;The basal body temperature;P4;Adverse circumstance; | — |
Countries
China
Contacts
Public ContactRui-Ning Liang
Outcome results
None listed