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The comparative of Vagiheal Barij® vaginal gel with estromarin cream in vaginal atrophy

Protocol summary

Study aim
Comparison of the effect of Vagiheal Barij® vaginal gel with estromarin cream in vaginal atrophy
Design
Randomised, , parallel group trial with blinded outcome assessment in patology . Randomisation was computerised with concealed randomisation sequence carried out at health centers
Settings and conduct
This study was conducted 70 menopause women who suffered from dyspareunia at health centers Arak university of medical sciences.Blindness and randomization will be done by numbered closed envelopes and block randomisation. VAS was used to record severity of dyspareunia, burning, itching dryness and cellular maturation index of vegina before and after intervention. The first Estromarin cream group received 2.5 gr cream to 3 weeks. After that counties it for 3 weeks after one-week rest. While the other group will give 2.5 gr to 7 nights then counties two times in weeks for two months. symptoms and signs of atrophic vaginit will evaluate during 3 weeks, one month and two month after intervention by VAS (0-10). Finally, cellular maturation index of vegina will be assessed two months after intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:Having vagenit atrophic, at least 2 years passing to menopause Exclusion criteria: The women who are contraindicated with estrogen therapy such as Hypertension drugs, diabetes, history of thrombo phlebitis or embolism, antiepileptic drugs, breast cancer, ovaries .. heart disease, abnormal bleeding, severe headaches
Intervention groups
Intervention group 1 is patients with atrophic vaginitis who using Vagiheal Barij gel Intervention group 2 is patients with atrophic vaginitis who using Estromarin cream
Main outcome variables
Itching, burning, dysparonia, itching, vaginal cell maturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190910044736N1
Registration date: 2019-12-04, 1398/09/13
Registration timing: prospective

Last update: 2019-12-04, 1398/09/13
Update count: 0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Katayon Vakilian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
dr.kvakilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2020-09-22, 1399/07/01
Trial completion date
2021-03-21, 1400/01/01
Scientific title
The comparative of Vagiheal Barij® vaginal gel with estromarin cream in vaginal atrophy
Public title
The comparative of Vagiheal Barij® vaginal gel with estromarin cream in vaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women with dysparonia itching and pain during intercourse dryness in vagina No abnormal uterus bleeding No diabetes No hypertension No heart diseases No thyroid disease At least two years pasted of menopause
Exclusion criteria:
Do not obey protocol treatment
Age
From 15 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 300
Actual sample size reached: 140
Randomization (investigator's opinion)
Randomized
Randomization description
They were randomly divided into two groups of intervention 1 and 2 by a randomized block allocation method (quadruple AA, BB).The blocks will be provided by Excel software with Rand's formula and the four blocks will be placed in closed envelopes respectively prepared by EXCEL , and the patients will be placed in one of the blocks by opening it.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Basij square,Peyambare Azam campus,Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-08-24, 1398/06/02
Ethics committee reference number
IR.ARAKMU.REC.1398.156

Health conditions studied

1

Description of health condition studied
Post menopausal Vaginitis atrophic
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis

Primary outcomes

1

Description
The mean of itching , burning ,disparonia and vaginal cell maturation base on Visual Analog Scale 0-10
Timepoint
Three weeks ,one and 2 months after treatment
Method of measurement
Visual Analog Scale 0-10

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Vagiheal gel Barij (Barij essence company), using an applicator (2.5 gram in 7 night)as a first treatment then 2 times in weeks. until 2 months.There is at least 5 micrograms of 8-perinyl narangine and at least 1.2 micrograms of xanthemol per vaginal gel vaginal gel
Category
Treatment - Drugs

2

Description
Intervention group2 : Estromarin cream group(Aboureihan company), using an applicator 2.5 gram in 21 days,then one week rest and continue for 21 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Arak
Full name of responsible person
Katayon Vakilian
Street address
Basij square, Peyambare Azam campus-Ark University of Medical Sciences,Arak,Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
cattyv2002@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij square, Peyambare Azam campus-Ark University of Medical Sciences,Arak,Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
cattyv2002@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Barij Essence
Full name of responsible person
Reza Bekhradi
Street address
NO78,Marzdaran street
City
Tehran
Province
Tehran
Postal code
3848176941
Phone
+98 21 4426 7992
Email
drbekhradi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakilian
Position
Associayed professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Basij square, Peyambare Azam campus-Ark University of Medical Sciences,Arak,Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
cattyv2002@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakilian
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Basij square, Peyambare Azam campus-Ark University of Medical Sciences,Arak,Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3507
Email
cattyv2002@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakilian
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Basij square, Peyambare Azam campus-Ark University of Medical Sciences,Arak,Iran
City
Arak
Province
Markazi
Postal code
3848146941
Phone
+98 86 3417 3507
Email
cattyv2002@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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