Tanshinone in Polycystic Ovary Syndrome

Sponsor

Heilongjiang University of Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT01452477

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: tanshinone Drug: tanshinone placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tanshinone tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.	Drug: tanshinone tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Placebo Comparator: tanshinone placebo placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.	Drug: tanshinone placebo placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.

Arm

Intervention/Treatment

Active Comparator: tanshinone

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

Drug: tanshinone

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

Placebo Comparator: tanshinone placebo

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

Drug: tanshinone placebo

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

Outcome Measures

Primary Outcome Measures

basal testosterone [3 months]
The primary outcome measure is a decrease in basal testosterone.

Secondary Outcome Measures

Ovarian androgen biosynthesis [3 months]
Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)
Whole body insulin action [3 months]
Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
Oral glucose tolerance test (OGTT) [3 months]
All the participants will undergo an overnight fast. After ingestion of a 75-g glucose load, blood samples will be obtained at 0, 30, 60, 90, and 120min for glucose and insulin level determination.
Reproductive hormones [3 months]
estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate.
Fasting gluco-lipid metabolic profiles [3 months]
quality of life [3 months]
the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL).
Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment [3 months]
Adverse events [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 36 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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