Study of the effect of combination therapy of Clotrimazole and Marshmallow in comparison with Clotrimazole alone on women with Candidial Vulvovaginitis
Study of Antifungal effect and reduction of fungal symptoms of combination of Clotrimazole and marshmallow cream on women with Candidial Vulvovaginitis in patient referring to AJUMS clinics
Design
In this study 100 Candidial Vulvovaginitis patients who are eligible for inclusion and exclution criteria in the study will be selected
Settings and conduct
convenience sampling will be done from all patients with Candidial Vulvovaginitis who referred to medical university gynecology clinics. These patients will be conscious about the study with provided necessary explanation. The study will be double blind and executor of plan and participants will be blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Having Candidial Vulvovaginitis that approved with positive culture
Age between 18_60 year old
Exclusion criteria:
Pregnancy
Diseases affect on this disease and its treatment, such as diabetes, AIDS and STD
Taking Antifungal drugs and drugs who affected on symptoms such as antihistamines and Corticosteroid
Use of vaginal washing solution
Intervention groups
There are 2 groups: intervention and control, intervention group will received combination of clotrimazole 1% and marshmallow 4% vaginal cream and control group will received clotrimazole 1% vaginal cream
Main outcome variables
outcome of culture of vaginal discharge; fungal symptoms; relapse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171128037650N1
Registration date:2018-01-22, 1396/11/02
Registration timing:registered_while_recruiting
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Fatemeh Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 5145
Email address
f_amini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of combination therapy of Clotrimazole and Marshmallow in comparison with Clotrimazole alone on women with Candidial Vulvovaginitis
Public title
The effect of Clotrimazole and marshmallow cream on Candidial Vulvovaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Concious consent to participate in the study
Candidial Vulvovaginitis according to positive culture result
Age between 18_60
Exclusion criteria:
pregnancy
Catching diseases affect on Candidial Vulvovaginitis such as diabetes, aids and sexually transmitted disease (STD)
Taking of Antifungal drugs and other drugs affect on disease symptoms such as Antihistamines
Use of vaginal washing solutions
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done with permuted block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind study: plan executor, reseacher, health care personnal and participants are unaware of the drug in the two groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of medical science
Street address
Central office of Shiraz university of medical science, Zand Ave, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1978_71345
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.SUMS.MED.REC.139691
Health conditions studied
1
Description of health condition studied
Candidal vulvovaginitis
ICD-10 code
N77.1
ICD-10 code description
Candidal vulvovaginitis
Primary outcomes
1
Description
fungal infection symptoms
Timepoint
before the study, In the 7th day after start of the study,In the 30th day
Method of measurement
Questionnaire planned for candidal vaginitis
Secondary outcomes
1
Description
Vaginal discharge culture
Timepoint
before treatment, 7th day, 30th day after treatment
Method of measurement
culture
Intervention groups
1
Description
Intervention group: There is two groups of patients, intervention and control. intervention group will received combination of Clotrimazole 1% and marshmallow 4% vaginal cream, with applicator from first day of treatment until 7th day, at a specified time each night at bed time.
Category
Treatment - Drugs
2
Description
Control group: control group will received Clotrimazole 1% vaginal cream with applicator from first day of treatment until 7 day, at a specified time each night at bed time
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz jundishapur university of medical science clinics
Full name of responsible person
Fatemeh Amini
Street address
َAhvaz jundishapur university of medical science. Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 0074
Email
Amini.bahar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr seyyed basir hashemi
Street address
Central office,Shiraz university of medical science, Zand Ave, Shiraz Sity
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3234 5145
Email
drjaladat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Amini
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz university of medical science, Zand Ave.
City
Shiraz
Province
Fars
Postal code
1978-71345
Phone
+98 71 3234 5144
Email
amini.bahar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Amini
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz university of medical science, Zand Ave.
City
Shiraz
Province
Fars
Postal code
1978-71345
Phone
+98 71 3234 5145
Email
amini.bahar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Amini
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz university of medical science, Zand ave.
City
Shiraz
Province
Fars
Postal code
197871345
Phone
+98 71 3234 5145
Email
amini.bahar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Nothing
When the data will become available and for how long
Nothing
To whom data/document is available
Nothing
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Nothing
What processes are involved for a request to access data/document