Protocol summary

Summary
The purpose of this clinical trial study was to compare the effects of Micosin vaginal cream with Miconazole vaginal cream for the treatment of mycotic vaginitis. This clinical trial was conducted on 120 women in their reproductive age who were diagnosed with candida vaginitis through clinical examinations and laboratory tests. Using randomized allocation method, the subjects were divided into two groups of 60 people. The participants in the first group were treated by Miconazole, while subjects in the second group were prescribed Micosin. Patients in both groups were asked to apply the drug once a day for seven consecutive days. After seven days of therapy, patients were re-examined through clinical and laboratory tests to compare the results. Inclusion criteria: women with Symptoms of Candida vaginitis infection in reproductive age. Exclusion criteria: any history of taking antibiotics or immunosuppressive drugs or vaginal medications during the four weeks prior to the start of the study; diagnosis with cervicitis; suffering from candida vaginitis for more than 3 times a year; pelvic inflammatory disease; pregnancy or menopause; patients with high risk conditions (such as diabetes, anemia, obesity, overt autoimmune disease, coagulation disorders); history of allergic reaction to garlic or cream of vaginal azole class; improper application of the medication; refusal to pay follow-up visits; personal decision by patients not to participate in the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013120715697N1
Registration date: 2014-03-02, 1392/12/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-02, 1392/12/11
Registrant information
Name
Shiva Alizadeh
Name of organization / entity
Islamic Azad university of rasht
Country
Iran (Islamic Republic of)
Phone
+98 13 1422 2154
Email address
gelayolalizadeh@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Islamic Azad University of Rasht
Expected recruitment start date
2013-05-07, 1392/02/17
Expected recruitment end date
2013-09-12, 1392/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Micosin vaginal cream compared to Miconazole vaginal cream for the treatment of mycotic vaginitis
Public title
Effect of Micosin vaginal cream compared to Miconazole vaginal cream for the treatment of mycotic vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with Symptoms of Candida vaginitis infection in reproductive age. Exclusion criteria: any history of taking antibiotics or immunosuppressive drugs or vaginal medications during the four weeks prior to the start of the study; diagnosis with cervicitis; suffering from candida vaginitis for more than 3 times a year; pelvic inflammatory disease; pregnancy or menopause; patients with high risk conditions (such as diabetes, anemia, obesity, overt autoimmune disease, coagulation disorders); history of allergic reaction to garlic or cream of vaginal azole class; improper application of the medication; refusal to pay follow-up visits; personal decision by patients not to participate in the study.
Age
From 16 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Islamic Azad University of Rasht
Street address
Department of Midwifery; Islamic Azad University of Rasht; Pole Taleshan; Rasht; Guilan; Iran
City
Rasht
Postal code
413353516
Approval date
2013-02-26, 1391/12/08
Ethics committee reference number
17-16-5-741

Health conditions studied

1

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

Primary outcomes

1

Description
Improvement of candidiasis vaginitis signs
Timepoint
One week after treatment
Method of measurement
cheak list; examination; wet mount; fungial culture.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Using one applicator of Micosin vaginal cream every night for 7 nights.
Category
Treatment - Drugs

2

Description
Intervention group 2: Using one applicator of Miconazole vaginal cream every night for 7 nights.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasole Akram Hospital
Full name of responsible person
Shiva Alizadeh
Street address
Department of Midwifery; Islamic Azad University of Rasht; Pole Taleshan; Rasht; Guilan; Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research; Islamic Azad University of Rasht
Full name of responsible person
Dr.Ali Mohamadi Torkashvand
Street address
Research Deputy of Islamic Azad University of Rasht; Islamic Azad University of Rasht; Pole Taleshan; Rasht; Guilan; Iran
City
Rasht
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; Islamic Azad University of Rasht
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
Islamic Azad University of Rasht
Full name of responsible person
shiva Alizadeh
Position
MSc in Midwifery / Lecturer; Department of Midwifery
Other areas of specialty/work
Street address
Department of Midwifery; Islamic Azad University of Rasht; Pole Taleshan; Rasht; Guilan; Iran
City
Rasht
Postal code
413353516
Phone
+98 13 1666 9930
Fax
Email
gelayolalizadeh@iaurasht.ac.ir; gelayolalizadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Rasht
Full name of responsible person
shiva Alizadeh
Position
MSc in Midwifery/ Lecturer; Department of Midwifery
Other areas of specialty/work
Street address
Department of Midwifery; Islamic Azad University of Rasht; Pole Taleshan; Rasht; Guilan; Iran
City
Rasht
Postal code
413353516
Phone
+98 13 1666 9930
Fax
Email
gelayolalizadeh@iaurasht.ac.ir; gelayolalizadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Rasht
Full name of responsible person
Shiva Alizadeh
Position
MSc in Midwifery/ Lecturer; Department of Midwifery
Other areas of specialty/work
Street address
Department of Midwifery; Islamic Azad University of Rasht; Pole Taleshan; Rasht; Guilan; Iran
City
Rasht
Postal code
413353516
Phone
+98 13 1666 9930
Fax
Email
gelayolalizadeh@iaurasht.ac.ir; gelayolalizadeh@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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