NCT03778099

The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome

The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial Phase: III 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. Objectives: Primary Objective: 1. 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. 2. 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. 3. 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 4. To evaluate the quality of life in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019. Secondary Objectives: * 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.

Conditions

• Polycystic Ovary Syndrome
• Ovulation

Interventions

Type	Name	Description
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.
DRUG	Placebo	450 mg of starch and 50 mg of cinnamon powder

Timeline

• Start date: 2018-09-20
• Primary completion: 2020-01-10
• Completion: 2020-02-03
• First posted: 2018-12-19
• Last updated: 2020-03-03

Locations

1 site across 1 country: Saudi Arabia