MedTrace Logo

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

NCT03778099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-03-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Principal Investigators

  • Wael H Alzhrani

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2020-01-10
Completion
2020-02-03

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778099 on ClinicalTrials.gov