Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, Cryptotanshinone
Brief summary
Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese medicine, this herb has been widely prescribed for several pathologies, including diabetes, acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of key molecules during both insulin signaling and androgen synthesis.The purpose of this study is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary Syndrome (PCOS) symptomatology.
Interventions
DRUGtanshinone
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
DRUGtanshinone placebo
placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Sponsors
Heilongjiang University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
Inclusion criteria
* Presence of PCOS diagnosed based on the Androgen Excess Society criteria. All subjects must have hyperandrogenism (hirsutism and/or hyperandrogenemia), ovarian dysfunction (oligoanovulation and/or polycystic ovaries), and exclusion of other androgen excess related disorders. Oligomenorrhea is defined as an intermenstrual interval \>35 days or \<8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval \>90 days. Clinical hyperandrogenism is defined as a Ferriman-Gallwey (FG) score ≥5 * Age of women from 18 to 35 years； * No desire of children within 6 month and use condoms for contraception.
Exclusion criteria
* Use of hormonal drugs or other medications, which can affect the results of the study especially Chinese herbal prescriptions in the past 12 weeks； * Patients with other androgen excess endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, severe insulin resistance, thyroid dysfunction； * Patients with history of sever cardiac , pulmonary, hepatic, renal, neurologic disease or mental illness； * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| basal testosterone | 3 months | The primary outcome measure is a decrease in basal testosterone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3 months | — |
| Ovarian androgen biosynthesis | 3 months | Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T) |
| Whole body insulin action | 3 months | Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test |
| Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment | 3 months | — |
| Reproductive hormones | 3 months | estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate. |
| Fasting gluco-lipid metabolic profiles | 3 months | — |
| quality of life | 3 months | the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL). |
| Oral glucose tolerance test (OGTT) | 3 months | All the participants will undergo an overnight fast. After ingestion of a 75-g glucose load, blood samples will be obtained at 0, 30, 60, 90, and 120min for glucose and insulin level determination. |
Countries
China
Contacts
Primary ContactXiaoke Wu, MD.PhD.
Outcome results
None listed