Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- basal testosterone
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 36 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
tanshinone
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Intervention: tanshinone (Drug)
tanshinone placebo
placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Intervention: tanshinone placebo (Drug)
Outcomes
Primary Outcomes
basal testosterone
Time Frame: 3 months
The primary outcome measure is a decrease in basal testosterone.
Secondary Outcomes
- Adverse events(3 months)
- Ovarian androgen biosynthesis(3 months)
- Whole body insulin action(3 months)
- Oral glucose tolerance test (OGTT)(3 months)
- Reproductive hormones(3 months)
- Fasting gluco-lipid metabolic profiles(3 months)
- quality of life(3 months)
- Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment(3 months)
Investigators
Xiaoke Wu
Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital
Heilongjiang University of Chinese Medicine