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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
RECRUITINGHuaian Maternal and Child Health Hospital
Huaian, Jiangsu, China
RECRUITINGLianyungang Maternal and Child Health Hospital
Lianyungang, Jiangsu, China
basal testosterone
The primary outcome measure is a decrease in basal testosterone.
Time frame: 3 months
Ovarian androgen biosynthesis
Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)
Time frame: 3 months
Whole body insulin action
Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
Time frame: 3 months
Oral glucose tolerance test (OGTT)
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.
Time frame: 3 months
Reproductive hormones
estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate.
Time frame: 3 months
Fasting gluco-lipid metabolic profiles
Time frame: 3 months
quality of life
the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL).
Time frame: 3 months
Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment
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JiangXi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China
COMPLETEDTime frame: 3 months
Adverse events
Time frame: 3 months