Polycystic Ovary SyndromeNCT01452477
Tanshinone in Polycystic Ovary Syndrome
A study testing tanshinone in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 4 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- tanshinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- Oct 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 2 recruiting
- Recruiting
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
Wenjuan Shen, doctor, +86-045182118464, shenwenjuankx@163.com
Yuehui Zhang, doctor, +86-045182118464, manbingPCOS@163.com
- Recruiting
Huaian Maternal and Child Health Hospital
Huaian, Jiangsu, 223001
Huiying Xue, Scholar, +8613505238015, haxuehuiying@126.com
Huiying Xue, bachlor
- Active, not recruiting
Lianyungang Maternal and Child Health Hospital
Lianyungang, Jiangsu, 222000
- Completed
JiangXi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330000
About this study
Official title: Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- tanshinone, tanshinone placebo
- Keywords
- Polycystic Ovary Syndrome, Cryptotanshinone
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tanshinoneDrug
tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
tanshinone placeboDrug
placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tanshinone | Active comparator | tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. Receives: Drug: tanshinone |
| tanshinone placebo | Placebo comparator | placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. Receives: Drug: tanshinone placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
basal testosterone
The primary outcome measure is a decrease in basal testosterone.
Measured: 3 months
Secondary outcomes (8)
Ovarian androgen biosynthesis
Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T)
Measured: 3 months
Whole body insulin action
Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
Measured: 3 months
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.
Measured: 3 months
Reproductive hormones
estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate.
Measured: 3 months
Fasting gluco-lipid metabolic profiles
Measured: 3 months
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).
Measured: 3 months
Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment
Measured: 3 months
Adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoke Wu, Heilongjiang University of Chinese Medicine
- Investigators
- Xiaoke Wu, docotor, Study chair, The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452477
- Sponsor's protocol ID
- Tanshinone-HLJUCM
- Status last verified
- Sep 2013
- First submitted
- 6 Oct 2011
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tanshinone on Hormonal and Metabolic Features in Women With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT01452477
- Acronym / sponsor ID
- Tanshinone-HLJUCM
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Cryptotanshinone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tanshinone | Active comparator | Drug: tanshinonetanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
| tanshinone placebo | Placebo comparator | Drug: tanshinone placeboplacebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tanshinonetanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. | Drug | tanshinone |
| tanshinone placeboplacebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. | Drug | tanshinone placebo |
Primary outcome
basal testosterone
Time frame: 3 months
The primary outcome measure is a decrease in basal testosterone.
8 secondary outcomes
Ovarian androgen biosynthesis
Time frame: 3 months
Whole body insulin action
Time frame: 3 months
Oral glucose tolerance test (OGTT)
Time frame: 3 months
Reproductive hormones
Time frame: 3 months
Fasting gluco-lipid metabolic profiles
Time frame: 3 months
quality of life
Time frame: 3 months
Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment
Time frame: 3 months
Adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoke Wu, docotor study chair
The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tanshinone in people with Polycystic Ovary Syndrome, run by Heilongjiang University of Chinese Medicine at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoke Wu, MD.PhD. (13796025599, xiaokewu2002@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
basal testosterone (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.