Protocol summary

Summary
(1)Objective:The aim of this study is to determine Effect Of Oral Of Cinnamon Extract Capsules On Metabolic And Hormonal Indices Of Women With Polycyctic Ovarian Syndrome(2) Design:Tis study is a triple blind randomise clinical trial and participation are divided into 2 groups(using cinnamon capsules in intervention group and using placebo cinnamon in control group).(3)population of this study:persons with polycyctic ovarian syndrome (4)Inclusion criteria :Age 40-18 years; At least two years past the age of menarche;BMI greater than 19 and less than 35.(5)Exclusion criteria:happen any Side effects of oral capsules of cinnamon extract ;Change the treatment regimen.(6)Sample size: In this study 66 persons with polycyctic ovarian syndrome will take part. (7) intervention:persons will divide to 2 groups (using cinnamon capsul and using placebo cinnamon) the first group will receive cinnamon extract capsule for 12 weeks( one capsule for each day) the second group will receive placebo capsule for 12 weeks( one capsule for each day).(8) Variable: metabolic and Hormonal indices are main out come variable.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021326161N2
Registration date: 2016-05-31, 1395/03/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-31, 1395/03/11
Registrant information
Name
Sanam Hadipoor Seyghalani
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3371 5589
Email address
hadipoor.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Oral Of Cinnamon Extract Capsules On Metabolic And Hormonal Indices Of Women With Polycyctic Ovarian Syndrome
Public title
The Effect Of Oral Of Cinnamon Extract Capsules On Metabolic And Hormonal Indices Of Women With Polycyctic Ovarian Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age 40-18 years; At least two years past the age of menarche;BMI greater than 19 and less than 35.Exclusion criteria:happen any Side effects of oral capsules of cinnamon extract gynecologist; Change the treatment regimen.
Age
From 18 years old to 39 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences , School of Nursing and Midwifery, Ethics Committee
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street , Tehran
City
Tehran
Postal code
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
IR.IUMS.REC.1395.9311373027

Health conditions studied

1

Description of health condition studied
Polycystic Ovarian Syndrome
ICD-10 code
E28.2-E28.
ICD-10 code description
Polycystic ovarian syndrome-Primary ovarian failure - Other ovarian dysfunctionilure- Ovarian dysfunction, unspecified

Primary outcomes

1

Description
Metabolic Indices
Timepoint
Patients are tested twice for Metabolic Indices . (One day before the first day of training–one day after the final day training ).
Method of measurement
sampling

2

Description
Hormonal Indices
Timepoint
Patients are tested twice for Hormonal Indices. (One day before the first day of training–one day after the final day training).
Method of measurement
sampling

Secondary outcomes

1

Description
Body Mass Index
Timepoint
Patients are tested twice for Body Mass Index . (One day before the first day of training–one day after the final day training).
Method of measurement
Scale And Tape - Measure

Intervention groups

1

Description
Using oral capsules of cinnamon extract in the intervention group
Category
Treatment - Drugs

2

Description
Using placebo in the control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Akbar Abadii, Rasol, Ali Asghar, Firozgar’s Hospital
Full name of responsible person
Sanam Hadipoor Seyghalani
Street address
Tehran, Pasdaran Street,Rastvan Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Morteza Naser Bakhat
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
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, Iran 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
Iran University of Medical Sciences , School of Nursing and Midwifery
Full name of responsible person
Sanam Hadipoor Seyghalani
Position
MSc student of midwifery
Other areas of specialty/work
Street address
Tehran, Pasdaran Street,Rastvan Street
City
Tehran
Postal code
Phone
+98 13 3371 5589
Fax
Email
s_hadipoor68@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences , School of Nursing and Midwifery
Full name of responsible person
leila Amini
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Yasemi Rashid Street,Valiasr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 4365 1815
Fax
Email
Amini.L@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences , School of Nursing and Midwifery
Full name of responsible person
Sanam Hadipoor Seyghalani
Position
MSc Student Of Midwifery
Other areas of specialty/work
Street address
Tehran, Pasdaran Street, Rastvan Street
City
Tehran
Postal code
Phone
00
Fax
Email
s_hadipoor68@yahoo.com
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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