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The effect of cinnamon and ginger compared with metformin on anthropometric data, on Blood Glucose, Lipid and sexual hormones in women with polycystic ovary syndrome

Protocol summary

Study aim
The effect of cinnamon and ginger compared with metformin on anthropometric data, Blood Glucose, Lipid and sexual hormones in women with polycystic ovary syndrome
Design
In this study, 100 patients with polycystic ovarian syndrome who were admitted to Motahari clinic of Shiraz were selected. The participants were randomly divided into four intervention and control groups and each participant was given a code Allocated
Settings and conduct
This study was done on the treatment of polycystic ovaries in Motahhari clinic of Shiraz in the form of double-blind clinical trial. blinding was performed by producing similar in shape capsules and in different colors
Participants/Inclusion and exclusion criteria
Inclusion criteria Age 40-20 years; Willingness to participate in the study; Poly cystic ovary syndrome diagnosis by a specialist according to Rotterdam criteria Exclusion criteria Diabetes mellitus; Hypersensitivity, Hyperprolactinemia, Thyroid problems,seizure, ,cardiovascular disease and cerebrovascular disease Pregnancy; lactation; Infertility treatment; using Blood glucose-lowering drugs or Blood glucose lowering drugs; using Insulin secretagogues drugs; using Contraceptives drugs; using Beta-blockers; cinnamon; ginger allergy; Need for OCP treatment
Intervention groups
Control group: Consume capsules containing 500 mg of rice flour as a placebo three times a day; Intervention group 1: Consume capsules containing 500 mg of ginger three times a day; Intervention group 2: Consume capsules containing 500 mg of cinnamon three times a day; Intervention group 3: Consume capsules containing 500 mg metformin three times a day
Main outcome variables
Weight, Waist circumference, Hip circumference, Fasting blood glucose, Insulin ,Cholesterol, Triglyceride, High density lipoprotein, Low density lipoprotein, Luteinizing hormone, Follicular stimulatory hormone, Testosterone, dihydroepidestrone, Sexual Hormone binding globulin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171227038105N1
Registration date: 2018-01-30, 1396/11/10
Registration timing: retrospective

Last update: 2018-01-30, 1396/11/10
Update count: 0
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
marsa dastgheib parsa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
mdastgheib@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-08-01, 1396/05/10
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
empty
Scientific title
The effect of cinnamon and ginger compared with metformin on anthropometric data, on Blood Glucose, Lipid and sexual hormones in women with polycystic ovary syndrome
Public title
Cinnamon and Ginger and Metformin for the treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-20 years Willingness to participate in the study Polycystic ovary syndrome diagnosis by a specialist according to Rotterdam criteria
Exclusion criteria:
Diabetes mellitus Pregnancy Infertility treatment useing Blood glucose-lowering drugs or Blood glucose lowering drugs cinnamon allergy Need for OCP treatment ginger allergy useing Beta-blockers useing Contraceptives Hypersensitivity Hyperprolactinemia Thyroid problems seizure cardiovascular disease cerebrovascular disease lactation useing Insulin secretagogues
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was performed in a double-blind manner. The participant, the researcher, the outcome evaluator, the data analyzerwere not informrd of intervention performed in the form of a random, and only the clinical caregiver knew the type of treatment
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
The headquarters of Shiraz University of Medical Sciences, Opposite of Palestine Street, Zand Street, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2017-06-11, 1396/03/21
Ethics committee reference number
IR.SUMS.REC.1396.41

Health conditions studied

1

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

Primary outcomes

1

Description
weight
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Balance

2

Description
Waist circumference
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Tape

3

Description
Hip circumference
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Tape

4

Description
FBS
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

5

Description
Insulin
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

6

Description
Cholesterol
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

7

Description
TG
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

8

Description
HDL
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

9

Description
LDL
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

10

Description
LH
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

11

Description
FSH
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

12

Description
Testosterone
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

13

Description
dehydroepiandrosterone
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

14

Description
SHBG
Timepoint
Before the experiment, eight weeks after intervention
Method of measurement
Standard enzymatic method

Secondary outcomes

1

Description
BMI
Timepoint
Before the intervention and one day after the end of the intervention
Method of measurement
weight devide into height2

Intervention groups

1

Description
First intervention group: Ginger - capsule 500 mg - 3 times a day - 8 weeks
Category
Treatment - Other

2

Description
Second intervention group: Ginger - 500 mg capsule - 3 times a day - 8 weeks
Category
Treatment - Other

3

Description
Third intervention group: metformin - 500 mg capsule - 3 times a day - 8 weeks
Category
Treatment - Drugs

4

Description
Control group: Rice flour - 500 mg capsule - 3 times a day - 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
ُSedighe Amooii
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3612 1000
Email
sedighehamooee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Syyed Basir Hashmi
Street address
Seventh Floor, Office of Research and Technology, Central Builing of Shiraz University of Medical Sciences, Opposite of Palestine Street, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Email
mdastgheib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marsa Dastgheib Parsa
Position
Master of Science in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Science, Facing the Power Club, Razi Blvd, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
mdastgheib@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Siyavash Babajafari
Position
MD PhD, nutritional sci
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Science, Facing the Power Club, Razi Blvd, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
jafaris@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marsa Dastgheib Parsa
Position
Master of Science in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Science, Facing the Power Club, Razi Blvd, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
mdastgheib@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After the study, information on the main and effective implications of interactions will be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and scientific institutions and industry professionals.
Under which criteria data/document could be used
The use of data will be allowed in the form of the source and the main author in the papers
From where data/document is obtainable
Through address: Shiraz - Faculty of Nutrition and Food Sciences phone number: 00989367560707 email: mdastgheib@sums.ac.ir
What processes are involved for a request to access data/document
After sending an email or referring to the address entered or by telephone, the information will be received by the applicant within a month.
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