This study was performed to evaluate the efficacy of cinnamon on menstrual cyclicity and metabolic dysfunction in women with polycystic ovarian syndrome. Inclusion criteria includes 18-38 year old women with at least two criteria of Rotterdam criteria for PCO and Low ovulation or lack of ovulation, and exclusion criteria includes pregnant or lactating women, underlying diseases and hypersensitivity to Cinnamon. In this double-blind randomized controlled clinical trial, 41 patients with PCOS were divided into two groups by blocked randomization; Intervention group received 1.5 grams of cinnamon daily, and control group received placebo for 6 months. Patients were followed at regular monthly intervals. Finally, anthropometric and laboratory parameters and the frequency of menstrual cycles and ovarian volume in cinnamon and placebo groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706162825N2
Registration date:2017-07-17, 1396/04/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-17, 1396/04/26
Registrant information
Name
Sepideh Peivandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4443 0501
Email address
speivandi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mazandaran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Cinnamon on Menstrual Cyclicity and Metabolic Dysfunction in Women with Polycystic Ovarian Syndrome
Public title
Efficacy of Cinnamon on Menstrual Cyclicity
Purpose
Treatment
Inclusion/Exclusion criteria
*Inclusion criteria: 18-38 year old women with at least two criteria of Rotterdam criteria for PCO; Low ovulation/ lack of ovulation (oligomenorrhoea/amenorrhea); Clinical or biochemical evidence of increased androgen; Sonography findings for PCO; BMI = 20-50 kg/m2.
**Exclusion criteria: Pregnant or lactating women; Under treating infertility; Diagnosed diabetics under treatment; Receiving insulin-stimulating drugs at 3 months prior to participating in the study; Treatment with estrogen or progesterone 3 months prior to participating in the study; Inhaled corticosteroid users; Patients with seizure; Cardiovascular or cerebrovascular diseases; Hypersensitivity to Cinnamon; Women who did not have the appropriate medical or psychological conditions for participation in the study; Women participated in medical research or other surgery on within 28 days.
Age
From 18 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The reason of double blinding the study is removing selective bias and effects of conflicting variables.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Valiasr Headway, Jouybar three-way, Imam Square
City
Sari
Postal code
4817844718
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
IR.MAZUMS.REC.95.2061
Health conditions studied
1
Description of health condition studied
Polycystic Ovarian Syndrome
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome or Stein-Leventhal syndrome
Primary outcomes
1
Description
Menstrual Cyclicity
Timepoint
Monthly
Method of measurement
History; Questionnaire
Secondary outcomes
1
Description
Metabolic Syndrome
Timepoint
After 6 months
Method of measurement
Physical exam; ELISA kit; Transvaginal sonography
Intervention groups
1
Description
In intervention group, 1.5 grams of cinnamon daily as two 250 mg capsules TDS for 6 months will be given to the patients.
Category
Treatment - Drugs
2
Description
In control group, placebo (Containing starch) daily as two 250 mg capsules TDS for 6 months will be given to the patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Sari
Full name of responsible person
Sepideh Peyvandi
Street address
Amir Mazandarani Avenue
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
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 of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Peyvandi
Position
Gynecologist & Infertility Fellowship / Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amir Mazandarani Hospital
City
Sari
Postal code
4815724971
Phone
+98 11 3310 5629
Fax
+98 11 3310 5629
Email
speivandi@mazums.ac.ir
Web page address
http://mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Peyvandi
Position
Gynecology & Infertility Felloship
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amir MAzandarani Avenue
City
Sari
Postal code
4815724971
Phone
+98 11 3310 5629
Fax
+98 11 3310 5629
Email
speivandi@mazums.ac.ir
Web page address
http://mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Peyvandi
Position
Gynecologist & Infertility Fellowship / Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Amir MAzandarani Avenue
City
Sari
Postal code
4815724971
Phone
+98 11 3310 5629
Fax
+98 11 3310 5629
Email
speivandi@mazums.ac.ir
Web page address
http://mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)