The effect of vaginal Royal jelly and vaginal premarin on the quality of life of menopause women who referred to gynecology clinic of Hajar Hospital in Shahrekord
This study was aimed to evaluate the effect of vaginal Royal jelly and vaginal premarin on the quality of life of menopause women who referred to gynecology clinic of Hajar Hospital in Shahrekord. This study was a clinical trial, double blind, single center, with random allocation. Physician and the patients were unaware about the medication type. The patients were allocated randomly in the study groups according to encoded sheets. The population of study was the eligible menopause women who referred to gynecology clinic of Hajar Hospital in Shahrekord. Inclusion criteria was diagnosis of menopause. The patients with sensitivity to premarin or honey products were excluded. Ninety menopause women were randomly allocated in premarin, Royal jelly, or lubricant groups (30 in each group). The intervention was conducted for three months. The quality of life and vaginal cytological assay were evaluated at the beginning and end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112220043N1
Registration date:2015-01-03, 1393/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Fatemeh Seiedy
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38133346692
Email address
st_seyedi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord Medical University of Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vaginal Royal jelly and vaginal premarin on the quality of life of menopause women who referred to gynecology clinic of Hajar Hospital in Shahrekord
Public title
The effect of vaginal Royal jelly and vaginal premarin on the quality of life of menopause women who referred to gynecology clinic of Hajar Hospital in Shahrekord
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Menopausal women; aged between 50 to 65 years; married women; diagnosis of vaginal atrophy
Exclusion criteria: Diabetes mellitus; history of endometrial cancer; history of breast cancer; cystocele; hormone therapy; sensitivity to honey products or premarin
Age
From 50 years old to 65 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Postal code
Approval date
2013-08-25, 1392/06/03
Ethics committee reference number
92-3-7
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Quality of life
Timepoint
At the beginning and end of the study
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Vaginal atrophy
Timepoint
At the beginning and end of the study
Method of measurement
Pap-Smear test
Intervention groups
1
Description
Premarin group: The patients in this group were treated with vaginal premarin 0.625% for three months.
Royal Jelly group: The patients in this group were treated with vaginal Royal jelly 15% in lubricant base for three months.
Category
Treatment - Drugs
2
Description
Lubricant group: The patients in this group were treated with vaginal lubricant gel for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinic of Shahrekord Hajar Hospital
Full name of responsible person
Dr Fatemeh Seiedy
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Fatemeh Seiedy
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Department of Obstetric and Gynecology
City
Shahrekord
Postal code
Phone
+98 38333346692
Fax
Email
ahkarbasbafi2014@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Fatemeh Seiedy
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333346692
Fax
Email
ahkarbasbafi2014@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Fatemeh Seiedy
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38333346692
Fax
Email
ahkarbasbafi2014@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)