The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Changes in insulin resistance
研究概览
简要总结
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:
- 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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Married women aged 18-40 seeking to become pregnant, meeting the Rotterdam criteria for polycystic ovary syndrome
排除标准
- •Current pregnancy or lactation.
- •Current use of treatment of infertility.
- •Established diagnosis of diabetes mellitus.
- •Use of Insulin-sensitizing treatment within the past three months.
- •Hormonal treatment involving estrogen or progesterone within the past three months.
- •Known hypersensitivity to cinnamon.
- •Use of statin medication.
- •Any other supplements that contain cinnamon within the past month.
- •BMI <18.5 or BMI >35.
研究组 & 干预措施
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.
干预措施: Cinnamon Cap 500 MG (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in insulin resistance
时间窗: 3 months
HOMA-IR
Menstrual frequency
时间窗: 3 months
No. of menses/ No. of months
Quality of life: Infertility quality of life questionnaire
时间窗: 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.
Ovulation Confirmation by Progesterone level
时间窗: 3 months
Progesterone level \> 3ng/mL or pregnancy confirmed
次要结局
- Pregnancy Rate(3 months)
研究者
Dr. Wael Alzhrani
Principle Investigator
King Abdulaziz University