Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Cinnamon Extract; Placebo
Intervention description: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.; Placebo capsules containing ground cereal.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No
Keywords: PCOS; Insulin resistance; Cinnamon extract; Irregular menstrual cycles; Ovarian cysts

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 investigators intend to confirm the salutatory effect of cinnamon on insulin
      resistance in larger group of study subjects.

      Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing
      age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming
      pregnant. The syndrome can also be associated with more serious conditions such as heart
      disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome,
      scientific studies showed that having too much insulin can be one of the reasons. In fact,
      almost every overweight woman with PCOS has been found to have high insulin levels.

      Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may
      also reduce the body's insulin level. Another study showed that daily use of cinnamon for
      forty days lowered the blood sugar level in patients with diabetes. Our own study also showed
      that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The
      purpose of this study is to see if cinnamon can help women with PCOS have more regular
      periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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).