Tanshinone in Polycystic Ovary Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Heilongjiang University of Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01452477
First received: October 6, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention
Polycystic Ovary Syndrome
Drug: tanshinone
Drug: tanshinone placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:


Further study details as provided by Heilongjiang University of Chinese Medicine:

Primary Outcome Measures:
  • basal testosterone [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary outcome measure is a decrease in basal testosterone.


Secondary Outcome Measures:
  • Ovarian androgen biosynthesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)

  • Whole body insulin action [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test

  • Oral glucose tolerance test (OGTT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452477

Contacts
Contact: Xiaoke Wu, MD.PhD. 13796025599 xiaokewu2002@vip.sina.com

Locations
China, Heilongjiang
Heilongjiang University of Chinese Medicine Recruiting
Harbin, Heilongjiang, China, 150040
Contact: Wenjuan Shen, doctor    +86-045182118464    shenwenjuankx@163.com   
Contact: Yuehui Zhang, doctor    +86-045182118464    manbingPCOS@163.com   
Principal Investigator: Wenjuan Shen, doctor         
China, Jiangsu
Huaian Maternal and Child Health Hospital Recruiting
Huaian, Jiangsu, China, 223001
Contact: Huiying Xue, Scholar    +8613505238015    haxuehuiying@126.com   
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
Investigators
Study Chair: Xiaoke Wu, docotor The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
  More Information

No publications provided

Responsible Party: Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01452477     History of Changes
Other Study ID Numbers: Tanshinone-HLJUCM
Study First Received: October 6, 2011
Last Updated: September 3, 2013
Health Authority: China: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Heilongjiang University of Chinese Medicine:
Polycystic Ovary Syndrome
Cryptotanshinone

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Tanshinone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anticoagulants
Hematologic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014