Polycystic Ovary SyndromeNCT01138930
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)
A study testing Berberine in people with Polycystic Ovary Syndrome and Obesity, run by Heilongjiang University of Chinese Medicine at 4 sites in China.
Trial summary
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity
- What is being tested?
- Berberine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- Jun 2010to Jun 2013
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age of women between 18 and 35 years.
- Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.
- Body mass index (BMI) equal to or greater than 23 kg/m2.
- With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume >10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5.
Who cannot join
- Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.
- Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome
- Patients with known sever organ dysfunction or mental illness.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Hongxia Ma, MD
Hongxia Ma, MD
- Recruiting
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Zhuoran Wang, MD
Zhuoran Wang, MD
- Recruiting
Forth Affiliated Hospital of Harbin Medcal University
Harbin, Heilongjiang, 150001
Shiyu Han, MD
Shiyu Han, MD
- Recruiting
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Harbin, Heilongjiang, 150040
Xiaoke Wu, MD.PhD., 86-451-8213 0094, xiaokewu2002@vip.sina.com
About this study
Official title: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Being tested
- Berberine, Placebo
- Keywords
- Polycystic Ovary Syndrome, Obesity
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
1.5g daily for 3 month
PlaceboDrug
placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Berberine | Experimental | Not described Receives: Drug: Berberine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body insulin action
Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp
Measured: 3 months
Secondary outcomes (7)
Oral glucose tolerance test (OGTT)
Measured: 3 months
Ovarian androgen biosynthesis
Measured: 3 months
Hormonal profile
Measured: 3 months
Fasting lipid metabolic profile
Measured: 3 months
Renal and liver function tests
Measured: 3 months
Adverse events
Measured: 3 months
6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 120 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
- Lihui Hou, MD., Study chair, The First Affliated Hospital,Heilongjiang University of Chinese Medicine .Xiaoke Wu, MD.PhD., Study chair, The First Affliated Hospital,Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138930
- Sponsor's protocol ID
- berberine2010
- Status last verified
- May 2013
- First submitted
- 7 Jun 2010
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang Y, Sun J, Zhang YJ, Chai QY, Zhang K, Ma HL, Wu XK, Liu JP. The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial. Trials. 2016 Oct 21;17(1):512. doi: 10.1186/s13063-016-1633-5.
PubMed 27769284Li Y, Ma H, Zhang Y, Kuang H, Ng EH, Hou L, Wu X. Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial. Trials. 2013 Jul 18;14:226. doi: 10.1186/1745-6215-14-226.
PubMed 23866924
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
- ClinicalTrials.gov ID
- NCT01138930
- Acronym / sponsor ID
- berberine2010
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Keywords
- Polycystic Ovary Syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 8 Jun 2010 (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.
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.
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 |
|---|---|---|
| Berberine | Experimental | Drug: Berberine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age of women between 18 and 35 years.
- Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.
- Body mass index (BMI) equal to or greater than 23 kg/m2.
- With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume >10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5.
Key exclusion criteria (3 listed)
- Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.
- Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome
- Patients with known sever organ dysfunction or mental illness.
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 |
|---|---|---|
| Berberine1.5g daily for 3 month | Drug | Berberine |
| Placeboplacebo daily | Drug | Placebo |
Primary outcome
Whole body insulin action
Time frame: 3 months
Glucose Disposal Rate measured by hyperinsulinemic euglycemic clamp
7 secondary outcomes
Oral glucose tolerance test (OGTT)
Time frame: 3 months
Ovarian androgen biosynthesis
Time frame: 3 months
Hormonal profile
Time frame: 3 months
Fasting lipid metabolic profile
Time frame: 3 months
Renal and liver function tests
Time frame: 3 months
Adverse events
Time frame: 3 months
6) Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment.
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Derived from this study: PubMed 27769284Zhang Y, Sun J, Zhang YJ, Chai QY, Zhang K, Ma HL, Wu XK, Liu JP. The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial. Trials. 2016 Oct 21;17(1):512. doi: 10.1186/s13063-016-1633-5.
- Derived from this study: PubMed 23866924Li Y, Ma H, Zhang Y, Kuang H, Ng EH, Hou L, Wu X. Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial. Trials. 2013 Jul 18;14:226. doi: 10.1186/1745-6215-14-226.
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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.
Lihui Hou, MD. study chair
The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Xiaoke Wu, MD.PhD. 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 Berberine in people with Polycystic Ovary Syndrome and Obesity, 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 4 inclusion and 3 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 10 May 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. (86-451-8213 0094, xiaokewu2002@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body insulin action (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138930, which also lists 2 linked publications.
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 10 May 2013.