Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Ключови думи
Резюме
Описание
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 take placebo pills (pills with no cinnamon extract) three times a day for 6 months. During this time, every patient will keep track of her period on a calendar.
Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the 6 months of medication. A total of 8 separate visits will be needed to finish the study. At the end of the study, the investigators will then compare the number of periods, blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.
Дати
| Последна проверка: | 05/31/2017 |
| Първо изпратено: | 11/28/2011 |
| Очаквано записване подадено: | 11/29/2011 |
| Първо публикувано: | 11/30/2011 |
| Изпратена последна актуализация: | 09/04/2017 |
| Последна актуализация публикувана: | 10/02/2017 |
| Дата на първите подадени резултати: | 05/25/2016 |
| Дата на първите подадени резултати от QC: | 07/06/2017 |
| Дата на първите публикувани резултати: | 08/01/2017 |
| Действителна начална дата на проучването: | 02/28/2011 |
| Приблизителна дата на първично завършване: | 04/30/2013 |
| Очаквана дата на завършване на проучването: | 03/31/2014 |
Състояние или заболяване
Интервенция / лечение
Drug: Cinnamon Extract Arm
Dietary Supplement: Placebo Arm
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Active Comparator: Cinnamon Extract Arm PCOS patients receiving abstract of cinnamon | Drug: Cinnamon Extract Arm 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 Comparator: Placebo Arm PCOS patients receiving placebo capsules | Dietary Supplement: Placebo Arm Placebo capsules containing ground cereal. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | 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). |
Резултат
Първични изходни мерки
1. Number of Menses During the Six Month Study Period. [Up to 6 months]
Вторични изходни мерки
1. Change in Insulin Resistance [Baseline and 6 months]
2. Change in Glucose Response [Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion]
