Status:
COMPLETED
Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Lead Sponsor:
Rogerio A. Lobo
Collaborating Sponsors:
Integrity Nutraceuticals International
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-38 years
Phase:
PHASE3
Brief Summary
The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the in...
Detailed Description
All patients will eat a balanced diet containing 1800 calories per day, but half of the patients in the study will take pre-made cinnamon extract pills three times a day, while the other half will tak...
Eligibility Criteria
Inclusion
- Patients aged greater than 18 years of age
- Ability to understand and willingness to comply with the study protocol
- Written informed consent
- Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries.
Exclusion
- Current pregnancy or lactation
- Liver disease or elevated liver enzymes
- Established diagnosis of diabetes mellitus
- Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association.
- Insulin sensitizing treatment within 3 months prior to or during the eight week study period.
- Hormonal treatment involving estrogen or progesterone 3 months prior to or during the study period, with the exception of medroxyprogesterone acetate for withdrawal bleeding.
- Systemic or inhaled corticosteroids.
- Known hypersensitive reaction to cinnamon.
- Patients with seizure disorders, known cardiovascular disease, or cerebrovascular disease.
- Body mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50).
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01483118
Start Date
March 1 2011
End Date
April 1 2014
Last Update
October 3 2017
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032