Protocol summary

Summary
The aim of this study was comparison of the effect of vaginal pomade of honey and clotrimazol on treatment of vaginal candidiasis in women referred to Shahrekord Hajar hospital gynecologic clinic. Study population was the women with clinical symptoms of vaginal candidiasis referred to Hajar hospital gynecologic clinic. This was a double blind quasi-experimental study that 80 patients were randomized into two honey and clotrimazol groups. Inclusion criteria were presence of clinical symptoms of candidiasis, get married, and tendency to participate in the study. Exclusion criteria were diabetes mellitus, immune deficiency, pregnancy, and consumption of immunosuppressive drugs. Patients, in clotrimazol group used one applicator of 2% clotrimazol pomad every night and in honey group, one applicator of 70% honey pomad every night for one week. At the first, three and seven days after beginning of treatment, severity of itching was assessed using Visual analogue Scale (VAS) in both groups. In addition, the severity of vaginal discharge and inflammation in patients were assessed using self- making questionnaire at the same times.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071013933N1
Registration date: 2013-07-14, 1392/04/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Shayeste Banaeian
Name of organization / entity
Shahrekord Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
shbanaeian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, shahrekord university of Medical sciences
Expected recruitment start date
2011-04-05, 1390/01/16
Expected recruitment end date
2013-07-06, 1392/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the effect of vaginal pomad of honey and clotrimazol on treatment of vaginal candidiasis in women referred to Hajar hospital gynecologic clinic in Shahrekord
Public title
Comparision the effect of vaginal pomad of honey and clotrimazol on treatment of vaginal candidiasis in women referred to Hajar hospital gynecologic clinic in Shahrekord
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of clinical symptoms of candidiasis; get married; tendency to participate in the study. Exclusion criteria:diabetes mellitus; immune deficiency; pregnancy; consumption of immunosuppressive drugs.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethics committee of Shahrekord University of Medical Sciences
Street address
Rahmatiee, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2010-12-12, 1389/09/21
Ethics committee reference number
89-9-3

Health conditions studied

1

Description of health condition studied
Candidal vaginitis
ICD-10 code
B37.3+
ICD-10 code description
Candidiasis of vulva and vagina (N77.1*)

Primary outcomes

1

Description
Vaginal discharge
Timepoint
At the first, three and seven days after beginning of treatment
Method of measurement
Self- making questionnaire

2

Description
Vaginal inflamation
Timepoint
At the first, three and seven days after beginning of treatment
Method of measurement
Self- making questionnaire

3

Description
Itching
Timepoint
At the first, three and seven days after beginning of treatment
Method of measurement
Visual Analoque Scale

Secondary outcomes

empty

Intervention groups

1

Description
Clotrimazol group: Patients in clotrimazol group used one applicator of 2% clotrimazol pomad every night for one week.
Category
Treatment - Drugs

2

Description
Honey group: Patients in honey group used one applicator of 70% honey pomad every night for one week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital gynecologic clinic
Full name of responsible person
Shayeste Banaeian
Street address
Hajar hospital gynecologic clinic, Parastar Street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research and technology, Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Aytollah 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
Vice chancellor for research and technology, 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
Shayeste Banaeian
Position
lecturer
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
shbanaeian@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
Shayeste Banaeian
Position
Lecturer
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
shbanaeian@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
Shayeste Banaeian
Position
Lecturer
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
shbanaeian@yahoo.com
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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