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Comparison of the effect of Clotrimazol vaginal cream and coconut oil vaginal cream in women with vaginal candidiasis

Protocol summary

Summary
This study is interventional and experimental clinical trial study was done to compare the effect of coconut oil vaginal cream with clotrimazol vaginal cream in the treatment of women with vaginal candida infection. Inclusion criteria: signs and symptoms of Candida vaginitis, positive direct smear of vaginal discharge Exclusion criteria: pregnant women, low compliance, recurrent Candida vaginitis (4 or more Candida vaginitis in a year), consumption of immunosuppressive drug or widespread antibiotics, history of diabetes, heart disease, using other vaginal creams or suppositories during the study period, consumption of systemic antifungal drugs during 2 weeks prior to the study, presence of non-candidal vaginitis, consumption of oral contraceptives. The study was triple blind (A blind clinical trial for the investigator, statistics analyst, and patients) and was conducted the method table of random numbers on 60 married women aged 45-15 years with clinical signs of the disease and laboratory confirmation. The participants were randomly divided to two treatment groups (coconut oil or clotrimazol). One applicator of the creams was applied nightly for a week and 2-7 days after completion of treatment, examinations and tests were performed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042521934N1
Registration date: 2016-08-24, 1395/06/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-24, 1395/06/03
Registrant information
Name
Sedigheh Sheidaei
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3774 7244
Email address
sheidaeis931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University Of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Clotrimazol vaginal cream and coconut oil vaginal cream in women with vaginal candidiasis
Public title
Comparison of the effect of Clotrimazol vaginal cream and coconut oil vaginal cream in women with vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signs and symptoms of Candida vaginitis, positive direct smear of vaginal discharge Exclusion criteria: pregnant women, low compliance, recurrent Candida vaginitis (4 or more Candida vaginitis in a year), consumption of immunosuppressive drug or widespread antibiotics, history of diabetes, heart disease, using other vaginal creams or suppositories during the study period, consumption of systemic antifungal drugs during 2 weeks prior to the study, presence of non-candidal vaginitis, consumption of oral contraceptives.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University Of Medical Sciences
Street address
Mashhad, Deputy of Research and Technology, After Hoveyze Cinema, Daneshgah street, Mashhad University of Medical Science.
City
Mashhad
Postal code
00989138813944
Approval date
2016-06-15, 1395/03/26
Ethics committee reference number
IR.MUMS.REC.1395.157

Health conditions studied

1

Description of health condition studied
Candidiasis of vulva and vagina
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina

Primary outcomes

1

Description
Compelet remission
Timepoint
2 to 7 days after treatment
Method of measurement
Evauation of clinical symptom's remission with questionnaire

Secondary outcomes

1

Description
Vaginal culture results
Timepoint
Before intervention and 2 to 7 days after intervention
Method of measurement
Vaginal smear

Intervention groups

1

Description
Intervention group Coconut oil, vaginal Cream, one applicator every night, for one Week.
Category
Treatment - Drugs

2

Description
Control group Clotrimazol, vaginal Cream, one applicator every night, for one week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem (AJ) Hospital
Full name of responsible person
Sedigheh Sheidaei
Street address
Mashhad, Shariati Square (Taghi Abad), Ahmad Abad Street, Ghaeem Educational, Research and Medical center
City
Mashhad

2

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Sedigheh Sheidaei
Street address
Mashhad, Ebne Sina Street, Emam Reza Square
City
Mashhad

3

Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Sedigheh Sheidaei
Street address
Mashhad, Behjat street, at the corner of Behjat 16
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Science
Full name of responsible person
Dr Saieed Eslami
Street address
Mashhad, Deputy of Research and Technology, After Hoveyze Cinema, Daneshgah street, Mashhad University of Medical Science
City
Mashhad
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, Mashhad University of Medical Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Farzane Jafar Nejad
Position
Master of Midwifery
Other areas of specialty/work
Street address
Doctoora intersection, Ibn Sina Street
City
Mashhad
Postal code
00980681697301
Phone
+98 51 3859 1511
Fax
Email
JaafarnejadF@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzane Jafar Nejad
Position
Master of Midwifery
Other areas of specialty/work
Street address
Doctoora intersection, Ibn Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
JaafarnejadF@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Sheidaei
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Ibn Sina Street, Doctora intersection
City
Mashhad
Postal code
00989137913199
Phone
Fax
Email
sheidaeis931@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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