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The effect of cinnamon powder on anthropometric, metabolic and hormonal factors in patients with polycystic ovarian syndrome

Protocol summary

Summary
General Purpose :The effect of cinnamon powder on the anthropometric, metabolic and hormonal factors in patients with polycystic ovarian syndrome Double blind clinical trial, Phase 2, Parallel Total sample count: 60 person, divided in two equal groups، Study time: 12 weeks. Randomization method : simple blocks patients in the case group would take capsules containing 500 mg of cinnamon powder, 3 times a day (morning, afternoon, evening) after meal, along with an standard classic treatment (10 mg medroxyprogesterone tablets daily, from the 15th day of menstruation for 10 days) Patients in the control group: would take 500 mg capsules containing starch with slight amount of cinnamon as placebo, 3 times a day (morning, afternoon, evening), after a meal, along with an standard classic treatment (10 mg medroxyprogesterone tablets daily, from the 15th day of menstruation for 10 days) Inclusion criteria: Informed consent for study participation، diagnosis of polycystic ovary syndrome according to Rotterdam criteria، Age of 18 to 45 years، Body mass index (BMI): equal or greater than 18. Exclusion criteria: Any diseases that would affect study parameters (such as diabetes, liver disease and etc,.) based on the patient's previous history، Taking blood pressure medications, statins, insulin injections and other anti diabetic drugs، Pregnancy، Breast-feeding ، Allergy to cinnamon. out comes: A change in anthropometric profile of patients including weight, body mass index, waist and hip circumference at the beginning and the end of the study. Changes in biochemical parameters of patients bodies including fasting blood glucose, two hour blood glucose, serum insulin levels and lipid profile at the beginning and the end of the study. Change in serum androgen levels at the beginning and the end of the study.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015121525537N1
Registration date: 2016-04-08, 1395/01/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Mahdie Hajimonfared
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 1433
Email address
hajimonfar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cinnamon powder on anthropometric, metabolic and hormonal factors in patients with polycystic ovarian syndrome
Public title
The effect of cinnamon on polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent to participate in the study؛ polycystic ovary syndrome diagnostic criteria Rotterdam are two of three of the following symptoms: i abnormal menstrual cycles (oligo dysmenorrhea, amenorrhea) ii polycystic ovaries on ultrasound iii clinical signs of hyperandrogenism (hirsutism -acne-) or biochemical signs of hyperandrogenism and also reject and Cushing's syndrome and congenital adrenal hyperplasia؛ age 45-18 years ؛Body mass index (BMI) greater than or equal to 18. Exclusion criteria: any disease affecting variables (diabetes, liver disease, thyroid, cardiovascular, renal, gastrointestinal, Cushing's syndrome, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia) based on the patient's previous history؛ Taking blood pressure medications or statins or anti-diabetic drugs and insulin injections ؛Pregnancy ؛Breast-feeding ؛use of any vitamin supplements, minerals and hormones for at least two months before the study ؛being under the special diet ؛Consumers oral contraceptives (OCP), glucocorticoids, anti-androgens, ovulation induction drugs ؛consumers of tobacco and alcohol ؛a history of allergy to cinnamon
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
block randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
medical faculty, Zand Boulevard, Shiraz
City
Shiraz
Postal code
Approval date
2015-12-15, 1394/09/24
Ethics committee reference number
IR.sums.REC.1394.160

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovarian syndrome

Primary outcomes

1

Description
weight, body mass index, waist and hip
Timepoint
Before study and after 12 weeks
Method of measurement
questionnaire

2

Description
fasting blood glucose, two hour blood glucose, serum insulin levels, lipid profile
Timepoint
Before study and after 12 weeks
Method of measurement
Blood sample

3

Description
serum androgen levels
Timepoint
Before study and after 12 weeks
Method of measurement
Blood sample

Secondary outcomes

1

Description
The menstrual cycle regularity
Timepoint
Before study and after 12 weeks
Method of measurement
Questions from Patients

Intervention groups

1

Description
Capsules containing 500 mg of cinnamon powder, 3 times a day (morning, afternoon, evening), after a meal with a standard treatment regimen (10 mg medroxyprogesterone tablets،from the 15th day of menstruation for 10 days
Category
Treatment - Drugs

2

Description
Control group: contains starch as placebo capsules, 3 times a day (morning, afternoon, evening), after a meal with a standard treatment regimen (10 mg medroxyprogesterone tablets،from day 15 of the menstrual period 10 days).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Mahdie Hajimonfared
Street address
Motahari Clinic, Namazi Square, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shiraz University of Medical Sciences
Full name of responsible person
Mahdie Hajimonfared
Street address
medical faculty ، Zand Boulevard, Shiraz
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of medical science
Full name of responsible person
Mahdie Hajimonfared
Position
MD
Other areas of specialty/work
Street address
Shiraz, Zand Boulevard, medical faculty
City
Shiraz
Postal code
Phone
+98 71336481433
Fax
Email
hajimonfared@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shiraz university of medical sciences
Full name of responsible person
Behie Namavar Jahromi
Position
Professor of female infertility
Other areas of specialty/work
Street address
Shiraz, Zand Boulevard, Shahid Faghihi hospital, section of women
City
shiraz
Postal code
Phone
+98 71332332365
Fax
Email
namavar@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahdie Hajimonfared
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 71 3648 1433
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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