Tanshinone in Polycystic Ovary Syndrome

Heilongjiang University of Chinese Medicine

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: tanshinone placebo; Drug: tanshinone

Study type: Interventional

Funder types: Other

Identifiers

NCT01452477

Tanshinone-HLJUCM

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

tanshinone

Active Comparator group

Description:

tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.

Treatment:

Drug: tanshinone

tanshinone placebo

Placebo Comparator group

Description:

placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.

Treatment:

Drug: tanshinone placebo