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Tanshinone in Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01452477
Recruitment Status : Unknown
Verified September 2013 by Xiaoke Wu, Heilongjiang University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : October 14, 2011
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. basal testosterone [ Time Frame: 3 months ]
    The primary outcome measure is a decrease in basal testosterone.

Secondary Outcome Measures :
  1. Ovarian androgen biosynthesis [ Time Frame: 3 months ]
    Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)

  2. Whole body insulin action [ Time Frame: 3 months ]
    Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test

  3. Oral glucose tolerance test (OGTT) [ Time Frame: 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.

  4. Reproductive hormones [ Time Frame: 3 months ]
    estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate.

  5. Fasting gluco-lipid metabolic profiles [ Time Frame: 3 months ]
  6. quality of life [ Time Frame: 3 months ]
    the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL).

  7. Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment [ Time Frame: 3 months ]
  8. Adverse events [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01452477

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Contact: Xiaoke Wu, MD.PhD. 13796025599

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China, Heilongjiang
Heilongjiang University of Chinese Medicine Recruiting
Harbin, Heilongjiang, China, 150040
Contact: Wenjuan Shen, doctor    +86-045182118464   
Contact: Yuehui Zhang, doctor    +86-045182118464   
Principal Investigator: Wenjuan Shen, doctor         
China, Jiangsu
Huaian Maternal and Child Health Hospital Recruiting
Huaian, Jiangsu, China, 223001
Contact: Huiying Xue, Scholar    +8613505238015   
Principal Investigator: Huiying Xue, bachlor         
Lianyungang Maternal and Child Health Hospital Active, not recruiting
Lianyungang, Jiangsu, China, 222000
China, Jiangxi
JiangXi University of Traditional Chinese Medicine Completed
Nanchang, Jiangxi, China, 330000
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
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Study Chair: Xiaoke Wu, docotor The First Affliated Hospital,Heilongjiang University of Chinese Medicine .

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Responsible Party: Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine Identifier: NCT01452477    
Other Study ID Numbers: Tanshinone-HLJUCM
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013
Keywords provided by Xiaoke Wu, Heilongjiang University of Chinese Medicine:
Polycystic Ovary Syndrome
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors