The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome (PCOS)
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|ClinicalTrials.gov Identifier: NCT03778099|
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 20, 2018
Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial
Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019.
Subject Participation Duration: Each participant will be followed for three months.
Intervention: 2g of cinnamon capsules daily will be provided.
- To compare the effectiveness of cinnamon supplement in combination with clomiphene citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King Abdul-Aziz University Hospital in Jeddah 2019.
- To measure the difference in insulin resistance after three months of cinnamon supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.
- To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019
- To evaluate the quality of life in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.
- To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019
Description of Study Design:
The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured using similar bottles labeled by letters A and B, to receive either the combination of cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo.
First visit: Patients will be evaluated during the early follicular phase for progesterone level and HOMA-IR and QUICK-I. Follow up: 3 months.
Last Visit: Patients will be re-evaluated to compare the difference.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Ovulation||Drug: Cinnamon Cap 500 MG Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial|
|Actual Study Start Date :||September 20, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Cinnamon Group
Two capsules of cinnamon 500mg twice per day after meals (2g/day). All capsules will be given simultaneously with the clomiphene citrate medication (standard treatment for infertility in women with PCOS). Participants will be asked to keep their normal lifestyle including daily food and physical activity level.
Drug: Cinnamon Cap 500 MG
The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.
Placebo Comparator: Placebo Group
Placebo capsules will contain 450 mg of starch and 50 mg of cinnamon powder (to improve blindness regarding taste and odor). Color, shape, and size of placebo capsules will be exactly the same as the cinnamon capsules.
2g/day along with clomiphene citrate
450 mg of starch and 50 mg of cinnamon powder
- Ovulation Confirmation by Progesterone level [ Time Frame: 3 months ]Progesterone level > 3ng/mL or pregnancy confirmed
- Changes in insulin resistance [ Time Frame: 3 months ]HOMA-IR
- Menstrual frequency [ Time Frame: 3 months ]No. of menses/ No. of months
- Quality of life: Infertility quality of life questionnaire [ Time Frame: 6 months ]
The 36 FertiQoL items are rated according to 5 types of response scales.
The response scales are:
Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4) Always (0), very often (1), quite often (2), Seldom (3), never (4) An extreme amount (0), very much (1), a moderate amount (2), a little (3), not at all (4) Completely (0), a great deal (1), moderately (2), not much (3), not at all (4)
Scores on the response scales are reversed, summed and scaled to range from 0 to 100. Higher scores on the subscales and total scores indicate better quality of life.
- Pregnancy Rate [ Time Frame: 3 months ]Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778099
|Contact: Wael H Alzhranifirstname.lastname@example.org|
|King Abdulaziz University||Recruiting|
|Jeddah, Saudi Arabia, 21589|
|Contact: Wael H Alzhrani +966502200580 email@example.com|
|Principal Investigator:||Wael H Alzhrani|