Tanshinone in Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: tanshinone
* Drug: tanshinone placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tanshinone<br>tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. | Drug: tanshinone<br>* tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.<br>|
| Placebo Comparator: tanshinone placebo<br>placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. | Drug: tanshinone placebo<br>* placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| basal testosterone | The primary outcome measure is a decrease in basal testosterone. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian androgen biosynthesis | Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T) | 3 months | 
| Whole body insulin action | Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test | 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. | 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. | 3 months | 
| Fasting gluco-lipid metabolic profiles |  | 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). | 3 months | 
| Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment |  | 3 months | 
| Adverse events |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Cryptotanshinone