Clinical trial NCT01452477: Tanshinone in Polycystic Ovary Syndrome
Official title: Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Cryptotanshinone
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: basal testosterone
timeFrame: 3 months
Secondary outcomes:
measure: Ovarian androgen biosynthesis
timeFrame: 3 months
measure: Whole body insulin action
timeFrame: 3 months
measure: Oral glucose tolerance test (OGTT)
timeFrame: 3 months
measure: Reproductive hormones
timeFrame: 3 months
measure: Fasting gluco-lipid metabolic profiles
timeFrame: 3 months
measure: quality of life
timeFrame: 3 months
measure: Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment
timeFrame: 3 months
measure: Adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Huaian
country: China
facility: Huaian Maternal and Child Health Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: Lianyungang Maternal and Child Health Hospital
state: Jiangsu
city: Nanchang
country: China
facility: JiangXi University of Traditional Chinese Medicine
state: Jiangxi
Study officials:
affiliation: The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
name: Xiaoke Wu, docotor
role: STUDY_CHAIR
References: