Status:
UNKNOWN
Tanshinone in Polycystic Ovary Syndrome
Lead Sponsor:
Heilongjiang University of Chinese Medicine
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-36 years
Phase:
NA
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, cardiovas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01452477
Start Date
October 1 2011
End Date
July 1 2014
Last Update
September 4 2013
Active Locations (4)
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1
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China, 150040
2
Huaian Maternal and Child Health Hospital
Huaian, Jiangsu, China, 223001
3
Lianyungang Maternal and Child Health Hospital
Lianyungang, Jiangsu, China, 222000
4
JiangXi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China, 330000