The aim of the study is to determine the effect of safron 30 mg/day on menopause women with moderate to severe hot flushing . Fifty women( 45 to 65 years old) with moderate to severe post menopausal hot flushing will be recruited if meet the eligibility criteria. The patients will be randomly assigned into one of the following groups to receive safron 30 mg/day or placebo, for 6 weeks. The severity of symptoms,will be measured by Hot flash Related Daily Interference and Hamilton Rating Scale For Depression at the baseline and second, 4th and 6th week after the intervention. Symptoms will also be registered daily. The follow-up period will be 6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602031556N85
Registration date:2016-02-04, 1394/11/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-04, 1394/11/15
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Saffron in the treatment of postmenopausal hot flash : a double-blind,randomised and placebo-controlled trial
Public title
Saffron in the treatment of postmenopausal hot flash
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged between 45-65 years old; menopause.
Exclusion criteria: moderate to severe post-menopausal hot flushing-five episodes per day from 2 months ago; sopping of the mens from 12 month ago; receiving estrogen or progesterone during the last two months; receiving antidepressants during the last month; receving Selective Estrogen Receptor Modulators including raloxifen and tamoxifen during the last month; receiving aromatase inhibitors such as Anastrozole, Letrozole, Exemestane during the last month;receving Leuprolide acetate during the last month; receiving clonidine during the last month; receving gabapentine and pregabalin during the last month; receiving hot flushing reducing medications during the last month; receiving amino acid supplements during the last month.
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshvarz Blvd.
City
Tehran
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.TUMS.REC.1394.1666
Health conditions studied
1
Description of health condition studied
Hot flashing
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Severity of hot flashing
Timepoint
Baseline and 2, 4, 6 weeks after beginnig of treatment
Method of measurement
By Hot flash Related Daily Interference
Secondary outcomes
1
Description
Severity of depression
Timepoint
Baseline and 2, 4, 6 weeks after beginnig of treatment
Method of measurement
By Hamilton Depression Rating scale
Intervention groups
1
Description
Capsule Saffron 30mg/day as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Capsule placebo as intervention group for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Sreeet
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Tehran University of Medical Sciences, Ghod St., Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Karegar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)