In this prospective study 40 menopausl women who reffer to menopausal clinic of women hospital and suffer from sexual dysfunction due to menopausl period entered into study. All participant fill questionnaire of female sexual function index, all the patients before enrolling to the groups fill informed consent. There are two arms; in group 1, 20 women take Nigella Sativa 600 mg per day for 3 months; in group 2, 20 women take placebo placebo for3 months. Then after 3 months again they will be evaluated with female sexual function index questionaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311066246N2
Registration date:2013-11-24, 1392/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-24, 1392/09/03
Registrant information
Name
Mojgan Asadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
asadim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology & Metabolism Research Institute, Tehran University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of placebo and Nigella sativa in treatment of sexual disorders in menopausal women of women general hospital
Public title
The effect of Nigella Sativa on sexual dysfunction in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: menopausal women with sexual dysfunction. Exclusion criteria: women who use HRT, antidepressants or they have history of depression,cardiovascular disorders,liver diseases ,diabetes.
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Endocrinology & Metabolism Research Institute
Street address
Endocrinology & Metabolism Research Institute,5th floor,Shariati Hospital, North Karegar St.
City
tehran
Postal code
1411413137
Approval date
2013-04-17, 1392/01/28
Ethics committee reference number
00251
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
The effect of Nigella Sativa on sexual dysfunction in menopausal women
Timepoint
3 months after use of drug
Method of measurement
Female Sexual Function Index questionnaire
Secondary outcomes
1
Description
The effect of Nigella Sativa on vasomotor disorders in menopausal women
Timepoint
After 3 months
Method of measurement
Menopause rating scale questionnaire
Intervention groups
1
Description
Intervention group: received 300mg sativa nigella oil once a day for three months
Category
Treatment - Drugs
2
Description
Control: received placebo orally once a day for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Women General Hospital(menopause clinic)
Full name of responsible person
Farnaz Nayebzadeh
Street address
Women's General Hospital- North Nejatollahi ave- Poule Karim Khan Zand
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology & Metabolism Research Institute
Full name of responsible person
Neda Mehrdad
Street address
Endocrinology & Metabolism Research Institute,5th floor,Shariati Hospital, North Karegar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology & Metabolism Research Institute
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
Women's general hospital, TUMS
Full name of responsible person
Farnaz Nayebzadeh
Position
General physician
Other areas of specialty/work
Street address
Women's general Hospital- North Nejatollahi ave- Poule Karim Khan zand
City
tehran
Postal code
Phone
+98 21 8889 7764
Fax
Email
f_nayebzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology & Metabolism Research Institute Tehran University of Medical Sciences
Full name of responsible person
Mojgan Asadi
Position
Assisstant professor
Other areas of specialty/work
Street address
Endocrinology & Metabolism Research Institute
City
Tehran
Postal code
Phone
+98 21 8822 0037
Fax
Email
asadim@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Endocrinology & Metabolism Research Institute Tehran University of Medical Sciences
Full name of responsible person
Mojgan Asadi
Position
Assisstant professor
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)