Tanshinone in Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01452477
• Other study ID #: Tanshinone-HLJUCM
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2011
• Last updated: September 3, 2013
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: September 2013
• Source: Heilongjiang University of Chinese Medicine
• Contact: Xiaoke Wu, MD.PhD.
• Phone: 13796025599
• Email: xiaokewu2002[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• tanshinone
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.

Locations

Country	Name	City	State
China	Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang
China	Huaian Maternal and Child Health Hospital	Huaian	Jiangsu
China	Lianyungang Maternal and Child Health Hospital	Lianyungang	Jiangsu
China	JiangXi University of Traditional Chinese Medicine	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	basal testosterone	The primary outcome measure is a decrease in basal testosterone.	3 months	No
Secondary	Ovarian androgen biosynthesis	Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)	3 months	No
Secondary	Whole body insulin action	Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test	3 months	No
Secondary	Oral glucose tolerance test (OGTT)	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.	3 months	No
Secondary	Reproductive hormones	estradiol (E2), 17-a-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate.	3 months	No
Secondary	Fasting gluco-lipid metabolic profiles		3 months	No
Secondary	quality of life	the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL).	3 months	No
Secondary	Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment		3 months	No
Secondary	Adverse events		3 months	No