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Tanshinone in Polycystic Ovary Syndrome

NCT ID: NCT01452477

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-07-31

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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Keywords

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Polycystic Ovary Syndrome Cryptotanshinone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tanshinone

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

Group Type ACTIVE_COMPARATOR

tanshinone

Intervention Type DRUG

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

tanshinone placebo

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

Group Type PLACEBO_COMPARATOR

tanshinone placebo

Intervention Type DRUG

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

Interventions

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tanshinone

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

Intervention Type DRUG

tanshinone placebo

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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Heilongjiang University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xiaoke Wu

Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoke Wu, docotor

Role: STUDY_CHAIR

The First Affliated Hospital,Heilongjiang University of Chinese Medicine .

Locations

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Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Site Status RECRUITING

Huaian Maternal and Child Health Hospital

Huaian, Jiangsu, China

Site Status RECRUITING

Lianyungang Maternal and Child Health Hospital

Lianyungang, Jiangsu, China

Site Status ACTIVE_NOT_RECRUITING

JiangXi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

Site Status COMPLETED

Countries

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China

Central Contacts

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Xiaoke Wu, MD.PhD.

Role: CONTACT

Phone: 13796025599

Email: [email protected]

Facility Contacts

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Wenjuan Shen, doctor

Role: primary

Yuehui Zhang, doctor

Role: backup

Huiying Xue, Scholar

Role: primary

Other Identifiers

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Tanshinone-HLJUCM

Identifier Type: -

Identifier Source: org_study_id