Protocol summary

Summary
This randomized, double blind, placebo controlled trial, will be conducted to asses the effect of Black seed on quality of life, menopausal symptoms and metabolic syndrome parameters among post menopausal women. Totally, 60 menopausal women aged 45–65 years (at least one year after amenorrhea history) who living in Yasuj are recruited. They shouldn’t have history of induced menopause following chemotherapy, radiotherapy or surgery; diagnosed cancers; take hormones or anti hypertensive, antihyperlipidemic or diabetic drugs; history of uncontrolled hypertension, myocardial infarction, stroke or have undiagnosed malignancies. The participants will be randomly divided to two groups of placebo and intervention. The intervention and control group will receive 2 gr of Black seed and placebo for 3 months respectively. We will measure B/P, Weight, Height, BMI, body composition, TG, Cholesterol, LDL, HDL, FBS, 17 β Stradiol, as well as Green Climacteric Scale and SF 36 before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013111615414N1
Registration date: 2014-02-20, 1392/12/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-20, 1392/12/01
Registrant information
Name
Saadat Parhizkar
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1222 9224
Email address
parhizkar.saadat@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nigella sativa supplementation on quality of life, Menopausal symptoms and metabolic syndrome among menopausal women
Public title
Effect of Black seed on Menopause
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria Menopausal women; aged between 45 to 65 years old; who agreed to participate in the study ;living in yasuj. Exclusion criteria Induced menopause following to surgery, chemotherapy or radiotherapy; taking steroid hormones in previous 3 months; taking anti hypertensive, anti diabetic or anti hyperlipidemic drugs; history of uncontrolled hypertension, MI,or diagnosed cancers.
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
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

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences Ethics Committee
Street address
Yasuj University of Medical Sciences, Motahari Boulevard, Yasuj
City
Yasuj
Postal code
7591994799
Approval date
2013-01-16, 1391/10/27
Ethics committee reference number
91/10/27/8

Health conditions studied

1

Description of health condition studied
Menopausal symptoms
ICD-10 code
O94, O95,
ICD-10 code description
Other obstetric conditions, not elsewhere classified

2

Description of health condition studied
Diabetes
ICD-10 code
E11, E12,
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Menopausal symptoms
Timepoint
at baseline and end of study
Method of measurement
Green Climacteric Scale

Secondary outcomes

1

Description
Quality of Life
Timepoint
at baseline and at the end of study
Method of measurement
SF-36 questionnaire

2

Description
Cholesterol
Timepoint
at baseline and at the end of study
Method of measurement
mg/dl

3

Description
Triglyceride
Timepoint
at baseline and at the end of study
Method of measurement
mg/dl

4

Description
LDL
Timepoint
at baseline and at the end of study
Method of measurement
mg/dl

5

Description
HDL
Timepoint
at baseline and at the end of study
Method of measurement
mg/dl

6

Description
FBS
Timepoint
at baseline and at the end of study
Method of measurement
mg/dl

7

Description
17β Stradiol
Timepoint
at baseline and at the end of study
Method of measurement
pg/dl

8

Description
FSH
Timepoint
at baseline and at the end of study
Method of measurement
miu/ml

9

Description
LH
Timepoint
at baseline and at the end of study
Method of measurement
miu/ml

10

Description
Blood pressure
Timepoint
at baseline and at the end of study
Method of measurement
mmHg

11

Description
weight
Timepoint
at baseline and at the end of study
Method of measurement
kg

12

Description
Height
Timepoint
at baseline and at the end of study
Method of measurement
cm

13

Description
BMI
Timepoint
at baseline and at the end of study
Method of measurement
kg/m2

14

Description
Body composition
Timepoint
at baseline and at the end of study
Method of measurement
Percent

Intervention groups

1

Description
Intervention group: Nigella sativa Capsule 2gr/day
Category
Prevention

2

Description
Control Group: Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Zir Tole health Section, Shahid Ashrafi Isfahani Health Center
Full name of responsible person
Fariba Mohammadi
Street address
Alley 2, Golzar Shohada Street, Zir Tole
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Yasuj University of Medical Sciences
Full name of responsible person
Dr Abd Mohammad Moosavi
Street address
Vice chancellor for research, Yasuj University of Medical Sciences, Motahari Boulevard, Yasuj
City
Yasuj
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, Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Saadat Parhizkar
Position
PhD/ Assistant Professor
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari Boulevard, Yasuj
City
Yasuj
Postal code
7591975114
Phone
+98 74 1222 9224
Fax
+98 74 1222 6715
Email
parhizkarsa@gmail.com
Web page address
http://www.drparhizkar.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Saadat Parhizkar
Position
PhD/Assistant Professor
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari Boulevard, Yasuj
City
Yasuj
Postal code
7591975114
Phone
+98 74 1222 9224
Fax
+98 74 1222 6715
Email
parhizkarsa@gmail.com
Web page address
http://www.drparhizkar.com

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Saadat parhizkar
Position
PhD/Assistant Professor
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari Boulevard, Yasuj
City
Yasuj
Postal code
7591975114
Phone
+98 74 1222 9224
Fax
+98 74 1222 6715
Email
parhizkarsa@yahoo.com
Web page address
http://www.drparhizkar.com

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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