This study will be aimed to examine the effect of taking Crocus Sativus capsule in production of happiness and treatment of sextual disorder menopausal 45 to 60 year old women.In this single-blind clinical trial, the method of sampling will be convenience sampling.So that, 40 menopausal qualified women who have blood pressure blew 160/110, don’t take the antidepressant or tranquilizers and don’t have suspicious lump in their breast examination, will be allocated in two groups of receiver of taking Crocus Sativus capsules or placebo.To hide the allocation, these capsules will be placed inside the numbering consecutive sealed opaque envelope by other research partner who is uninvolved in the sampling.Afterwards, women will be randomly divided into two groups and will be given 28 crocus sativus 30 mg capsules or placebo to each of them to take daily. The researcher will be called once a week to women to be sure for regular take of capsules and after 4 weeks, will be called again and happiness and sextual function questionnaire will be re-completed by them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050722099N2
Registration date:2015-09-11, 1394/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-11, 1394/06/20
Registrant information
Name
mahboobeh ghorbani
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3228 9019
Email address
ghorbani.mahboobeh@gmail.com
Recruitment status
Recruitment complete
Funding source
North Khorasan University of Medical Sciences
Expected recruitment start date
2015-08-11, 1394/05/20
Expected recruitment end date
2016-02-09, 1394/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Crocus sativus on happiness and sexual function among menopausal women
Public title
The effect of Crocus Sativus in production of happiness and treatment of sextual disorders among menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian Muslims women;45 to 60 year old women;Fifth grade of Elementray School (in Iran educational sysytem);Married women;Women who passed at least 12 month after the last menstrual period or had more than 40 FSH;Women with natural menopause.
Exclusion criteri:Getting the Estrogen/ Progestin Hormone in the last 3 month;spotting in the last year;Using tobacco products (drugs, cigarette, hookah) or alcohol;using of drug/drugs to decrease menopausal symptoms or tranquilizers, antidepressants and anticoagulants in the past month;Having blood pressure more than 160/110;Having stressful life event in the past 6 month;Detecting of a lump or an abnormality in the breast examination or women with malignancecy.
Age
From 49 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research of North Khorasan University of Medical Sciences
Street address
Vice Chancellor for Research of North Khorasan University of Medical Sciences , Shahid Mofakhar Alley, Kargar Square, Bojnord
City
Bojnord
Postal code
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.nkumf.rec.1394.c
Health conditions studied
1
Description of health condition studied
sexual function
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
2
Description of health condition studied
Happiness
ICD-10 code
F38
ICD-10 code description
Other mood [affective] disorders
Primary outcomes
1
Description
Happiness
Timepoint
Before intervention and 4 weeks after taking the capsules.
Method of measurement
Oxford Happiness Inventory(OHI)
2
Description
Sexual Function
Timepoint
Before intervention and 4 weeks after taking the capsules.
Method of measurement
Female Sexual Function Index(FSFI)
Secondary outcomes
empty
Intervention groups
1
Description
The interventional group: be taken daily 30 mg oral crocus sativus capsules for 28 days.
Category
Treatment - Drugs
2
Description
The control group: be taken daily 30 mg placebo capsules for 28 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Mahboobeh Ghorbani
Street address
Imam Reza Clinic , Khoramshahr Square , Bojnord .
City
Bojnord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of North Khorasan University of Medical Sciences
Full name of responsible person
Dr. Alireza Golshan
Street address
Vice Chancellor for Research of North Khorasan University of Medical Sciences , Shahid Mofakhar Alley, Kargar Square, Bojnord
City
Bojnord
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 of North Khorasan 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
Faculty of Nursing and Midwifery
Full name of responsible person
Mahboobeh Ghorbani
Position
Instructor of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing , Midwifery and Medicine, Alghadir, Shahriar Street, Bojnord.
City
Bojnord
Postal code
Phone
+98 58 3229 7096
Fax
Email
ghorbani.mahboobeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Mahboobeh Ghorbani
Position
Instructor of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing , Midwifery and Medicine, Alghadir, Shahriar Street, Bojnord
City
Bojnord
Postal code
Phone
+98 58 3228 9019
Fax
Email
ghorbani.mahboobeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Mahboobeh Ghorbani
Position
Instructor of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing , Midwifery and Medicine, Alghadir, Shahriar Street, Bojnord
City
Bojnord
Postal code
Phone
+98 58 3228 9019
Fax
Email
ghorbani.mahboobeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)