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Tanshinone in Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tanshinone
tanshinone placebo
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Cryptotanshinone

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Heilongjiang University of Chinese MedicineRecruiting
  • Huaian Maternal and Child Health HospitalRecruiting
  • Lianyungang Maternal and Child Health Hospital
  • JiangXi University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

tanshinone

tanshinone placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

basal testosterone
The primary outcome measure is a decrease in basal testosterone.

Secondary Outcome Measures

Ovarian androgen biosynthesis
Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)
Whole body insulin action
Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
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.
Reproductive hormones
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
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).
Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment
Adverse events

Full Information

First Posted
October 6, 2011
Last Updated
September 3, 2013
Sponsor
Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01452477
Brief Title
Tanshinone in Polycystic Ovary Syndrome
Official Title
Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome, Cryptotanshinone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tanshinone
Arm Type
Active Comparator
Arm Description
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Arm Title
tanshinone placebo
Arm Type
Placebo Comparator
Arm Description
placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
tanshinone
Intervention Description
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
tanshinone placebo
Intervention Description
placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
Primary Outcome Measure Information:
Title
basal testosterone
Description
The primary outcome measure is a decrease in basal testosterone.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Ovarian androgen biosynthesis
Description
Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)
Time Frame
3 months
Title
Whole body insulin action
Description
Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
Time Frame
3 months
Title
Oral glucose tolerance test (OGTT)
Description
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.
Time Frame
3 months
Title
Reproductive hormones
Description
estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate.
Time Frame
3 months
Title
Fasting gluco-lipid metabolic profiles
Time Frame
3 months
Title
quality of life
Description
the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL).
Time Frame
3 months
Title
Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment
Time Frame
3 months
Title
Adverse events
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoke Wu, MD.PhD.
Phone
13796025599
Email
xiaokewu2002@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoke Wu, docotor
Organizational Affiliation
The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Official's Role
Study Chair
Facility Information:
Facility Name
Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjuan Shen, doctor
Phone
+86-045182118464
Email
shenwenjuankx@163.com
First Name & Middle Initial & Last Name & Degree
Yuehui Zhang, doctor
Phone
+86-045182118464
Email
manbingPCOS@163.com
First Name & Middle Initial & Last Name & Degree
Wenjuan Shen, doctor
Facility Name
Huaian Maternal and Child Health Hospital
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiying Xue, Scholar
Phone
+8613505238015
Email
haxuehuiying@126.com
First Name & Middle Initial & Last Name & Degree
Huiying Xue, bachlor
Facility Name
Lianyungang Maternal and Child Health Hospital
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
JiangXi University of Traditional Chinese Medicine
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Completed

12. IPD Sharing Statement

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Tanshinone in Polycystic Ovary Syndrome

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