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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
Sponsor:
Information provided by (Responsible Party):
Dr. Wael Alzhrani, King Abdulaziz University

Brief 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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Ovulation Drug: Cinnamon Cap 500 MG Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: Placebo
450 mg of starch and 50 mg of cinnamon powder




Primary Outcome Measures :
  1. Ovulation Confirmation by Progesterone level [ Time Frame: 3 months ]
    Progesterone level > 3ng/mL or pregnancy confirmed

  2. Changes in insulin resistance [ Time Frame: 3 months ]
    HOMA-IR

  3. Menstrual frequency [ Time Frame: 3 months ]
    No. of menses/ No. of months

  4. 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.



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with PCOS
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Married women aged 18-40 seeking to become pregnant, meeting the Rotterdam criteria for polycystic ovary syndrome

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Wael H Alzhrani +966502200580 dr.wael.hz@gmail.com

Locations
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Saudi Arabia
King Abdulaziz University Recruiting
Jeddah, Saudi Arabia, 21589
Contact: Wael H Alzhrani    +966502200580    dr.wael.hz@gmail.com   
Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Wael H Alzhrani

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Responsible Party: Dr. Wael Alzhrani, Principle Investigator, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT03778099     History of Changes
Other Study ID Numbers: W-001
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Wael Alzhrani, King Abdulaziz University:
PCOS
Ovulation
Cinnamon

Additional relevant MeSH terms:
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Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases