Protocol summary

Summary
The main objective of the study: the effect of oral Salvia officinalis extracts capsules on metabolic parameters, oxidative stress and general health in women with polycystic ovary syndrome / study method: randomized clinical trial, placebo-controlled, triple-blind. / Samples: all Iranian women with polycystic ovary syndrome who were referred to infertility and gynecology clinics of the Firouzgar hospital and approved private centers having at least two of three Rotterdam consensus criteria will participate. Women should not have taken any food supplements, hormonal drugs (except oral contraceptive compounds), reducing or increasing the weight compounds, The blood lipid lowering drugs, The blood glucose lowering drugs and Anti-epileptic drugs should not have been used during the study and two months before it and patients with chronic physical diseases and mentally disorders, addicted to drugs and having allergy to salvia officinalis, will be excluded. After approval of ethical committee of Iran University of Medical Sciences all patients will give their written informed consents and then the samples with triple-blind manner will be randomly divided into two groups: treatment with oral salvia officinalis extract or placebo. Before any intervention all participants will fill the Demographic information questionnaire, Health history form and GHQ28 ( general health questionnaire ) and after 12 to 14 hours of fasting 10 cc of blood will be collected to measure glucose, insulin, cholesterol, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL) , triglycerides and markers of oxidative stress (MDA, TAC) from each participant. The experimental group who will receive salvia officinalis alcoholic extract 150 mg capsules twice a day orally and the control group will take similar capsules with Starch as a placebo for 8 weeks. After 2 months of study blood will be taken from all subjects for assessment metabolic and oxidative stress markers and GHQ-28 questionnaire will be filled again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504146917N2
Registration date: 2015-10-03, 1394/07/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-03, 1394/07/11
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
l-amini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of salvia officinalis extract capsules on health indexes of women with policyctic ovary syndrome
Public title
Effect of sage on health of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-The samples should have the desire to participate in the study and informed consent was taken from them. 2- They should have Iranian nationality. 3- Don’t use food and drug supplements such as vitamins, minerals... 4- They shouldn't be on a special diet such as Low-sugar, low-fat or vegetarian diets. 5- Absence of known mental illness or chronic physical disease according to the information given from the patient. 6- They shouldn't be pregnant and has no desire to become pregnant during the study. 7- The participant and her wife, shouldn't be addicted to drugs and also shouldn't take any tranquilizers or psychotropic substances. 8 -Hormonal drugs (except oral contraceptive compounds), reducing or increasing the weight compounds, the blood lipid lowering drugs, the blood glucose lowering drugs and Anti-epileptic drugs should not have been used during the study and two months before it. 9- They are not undergoing infertility treatment. 10- They should not have been under the influence of stressful events during the last three months. Exclusion criteria: 1- Participants withdrew from participating in the study at any part of study. 2- In case of intolerable or harmful side effects, such as severe nausea and vomiting or allergy caused by the salvia officinalis capsules.
Age
From 15 years old to 55 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)
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
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Postal code
1449614535
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.IUMS.REC.1394.9211373221

Health conditions studied

1

Description of health condition studied
Policyctic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome Stein-Leventhal syndrome

Primary outcomes

1

Description
Wheight
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Weight in kilograms

2

Description
Waist circumference
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Centimetre

3

Description
Hip circumference
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Centimetre

4

Description
Body Mass Index ( BMI )
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2

5

Description
Systolic and diastolic blood pressure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Will be measured with Sphygmomanomete in millimeters of mercury (mm Hg)

6

Description
Fasting Blood Sugar ( FBS )
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Venous blood samples will be collected and then enzymatic colorimetricd methode using special kits and autoanalyzer will be measured in milligrams per deciliter

7

Description
Triglyceride
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Venous blood samples will be collected and then enzymatic colorimetricd methode using special kits and autoanalyzer will be measured in milligrams per deciliter

8

Description
Cholestrol
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Venous blood samples will be collected and then enzymatic colorimetricd methode using special kits and autoanalyzer will be measured in milligrams per deciliter

9

Description
Low density lipoprotein cholesterol (LDL)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Venous blood samples will be collected and then enzymatic colorimetricd methode using special kits and autoanalyzer will be measured in milligrams per deciliter

10

Description
High density lipoprotein cholesterol (HDL)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Venous blood samples will be collected and then enzymatic colorimetricd methode using special kits and autoanalyzer will be measured in milligrams per deciliter

11

Description
Malondialdehyde ( MDA )
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
The MDA-TBA adduct formed by the reaction of MDA and TBA under high temperature. Malondialdehyde is measured in colorimetrically at 532 in nmol/lit

12

Description
Total antioxidant capacity
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
According to ability for reducing Fe+3 to Fe+2, which can combine with phenanthrene and form a colored compound. According to the chemical colorimetry / mmol/lit

13

Description
Fasting insulin level
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Human Insulin ELISA Kit in picomol/lit ( or μU/mL )

14

Description
General mental health
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
General health questionnaire - 28 ( GHQ-28 )

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group will receive salvia officinalis alcoholic extract 150 mg capsules twice a day orally for 8 weeks .
Category
Treatment - Drugs

2

Description
The control group will take similar capsules with starch as a placebo twice a day for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital, infertility clinic
Full name of responsible person
Dr. Zahra Raoufi
Street address
Firoozgar hospital, Behafarin St., Valiasr Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research & Technology
Street address
5th floor - central committee - Iran University of Medical Sciences - Shahid Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Nrsing and Midwifery
Full name of responsible person
Arezoo Malaki hajiagha
Position
Master of science in Midwifery Student
Other areas of specialty/work
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St. Tehran- Iran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
+98 88201978
Email
ashoo1992@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical sciences, School of Nursing & Midwifery
Full name of responsible person
Leila Amini
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Rashid Yasemi St., Valiasr St.
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
le.amini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Irani University of Medical Sciences, School of Nursing & Midwifery
Full name of responsible person
Arezoo Malaki Haji Agha
Position
Master of Sciences in Midwifery student
Other areas of specialty/work
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St. Tehran- Iran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
ashoo1992@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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