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

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778099
• Other study ID #: W-001
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2018
• Est. completion date: February 3, 2020

Study information

• Verified date: March 2020
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 3, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ovulation
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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
450 mg of starch and 50 mg of cinnamon powder

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation Confirmation by Progesterone level	Progesterone level > 3ng/mL or pregnancy confirmed	3 months
Primary	Changes in insulin resistance	HOMA-IR	3 months
Primary	Menstrual frequency	No. of menses/ No. of months	3 months
Primary	Quality of life: Infertility quality of life questionnaire	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.	6 months
Secondary	Pregnancy Rate	Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000	3 months