Investigation on the efficacy and safety of Ceylon cinnamon (Cinammomum zeylanicum) compared to metformin in ameliorating symptoms of Polycystic Ovary Syndrome (PCOS): A randomized controlled trial
- Conditions
- Polycystic ovary syndrome (PCOS)
- Registration Number
- SLCTR/2022/009
- Lead Sponsor
- niversity of Peradeniya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Aged between 18 to 45 years
2. Women who diagnosed with PCOS according to the Rotterdam criteria
3. Body Mass Index (BMI) equal or greater than 18
4. Willingness to sign the consent form
1. Pregnant or lactation mothers
2. Women who being under treatment for infertility or subfertility
3. Women who diagnosis of hyperprolactinemia, thyroid disorders, Cushing syndrome, adrenal hyperplasia, hypertension and Diabetes
4. Patients who were on any medication including oral contraceptive pills or over the counter medication and insulin-sensitizing agents or hormonal treatments involving estrogen, progesterone or any drug inducing insulin resistance within the past 3 months prior to the study enrolment.
5. Women with acute infections and illness 6. Unconsented patients
7. Patients diagnosed with psychiatric illnesses
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of menstrual cyclicity evidence by Proportion of resumption of normal menstrual cycle and menstrual frequency (number of menses/ month)<br>The typical menstrual cycle pattern is 28 ± 7 days with menstrual flow lasting 4 ± 2 days and blood loss averaging 20 to 60 mL.<br>Menstrual Cycle Patterns: will be assessed by cycle frequency, duration, regularity and volume.<br>Frequency is defined as the interval between menstrual cycles, duration as the period from the beginning to the end of menstrual bleeding and regularity as variations of menstrual cycle length.<br> [Day 1, 14, 21 , 2 months from visit 1 and final visit at 3 months from visit 1 ]<br>Change in serum androgen level (total testosterone, SHBG and LH/FSH ratio) [ Day 1 and and final visit at 3 months from visit 1 ]<br>Change in serum androgen level (total testosterone, SHBG and LH/FSH ratio) [ Day 1 and and final visit at 3 months from visit 1 ]<br>
- Secondary Outcome Measures
Name Time Method