The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome
NCT ID: NCT03778099
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
33 participants
INTERVENTIONAL
2018-09-20
2020-02-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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 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
Placebo
450 mg of starch and 50 mg of cinnamon powder
Interventions
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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
450 mg of starch and 50 mg of cinnamon powder
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
40 Years
FEMALE
No
Sponsors
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King Abdulaziz University
OTHER
Responsible Party
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Dr. Wael Alzhrani
Principle Investigator
Principal Investigators
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Wael H Alzhrani
Role: PRINCIPAL_INVESTIGATOR
Locations
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King Abdulaziz University
Jeddah, , Saudi Arabia
Countries
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Other Identifiers
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W-001
Identifier Type: -
Identifier Source: org_study_id
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