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Comparing the effect of Walnut Green Husk Vaginal Cream with Fluconazole for treatment and relapse of Candida Vaginitis

Protocol summary

Summary
The aim of this study was to comparing the effect of walnut green husk vaginal cream with Fluconazole for treatment and relapse of candida vaginitis. This randomized, double-blind study is carried out at East Ahvaz number one health center. Inclusion criteria: sign and symptoms of vulvovaginal candidiasis, married women between 18-45 years old, Patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse. Exclusion criteria: Women who had used antibiotics, immunosuppressive drugs, or any vaginal drugs 14 days before the study, pregnancy, breast feeding, diabetes and immunodeficiency side effects of the drug, 75 married women eligible for the study of vaginal discharge, itching, and burning. . . Complain and positive fungal culture, random sampling method and divided into 3 groups: 1) walnut green husk vaginal cream + Cap Placebo Fluconazole .2) Cap Fluconazole 100 mg + Placebo vaginal cream. 3) walnut green husk vaginal cream + Cap Fluconazole 100 mg, and will be examined. Physical examination, Vaginal pH and vaginal smear measured before and after interventions and compared in both the group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112819743N3
Registration date: 2015-12-04, 1394/09/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-12-04, 1394/09/13
Registrant information
Name
Masumeh Yaralizadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
yaralizadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Walnut Green Husk Vaginal Cream with Fluconazole for treatment and relapse of Candida Vaginitis
Public title
the effect of Walnut Green Husk Vaginal Cream for treatment Candida Vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sign and symptoms of vulvovaginal candidiasis, married women between 18-45 years old, Patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse. Exclusion criteria: Women who had used antibiotics, immunosuppressive drugs, or any vaginal drugs 14 days before the study, pregnancy, breast feeding, diabetes and immunodeficiency side effects of the drug.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Ahvaz Jundishapur University of Medical Science
Street address
Ground Floor, Department of Research and Information Technology, Ahvaz Jundishapur University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Postal code
Approval date
2015-11-28, 1394/09/07
Ethics committee reference number
AJUMS.REC.1394.466

Health conditions studied

1

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

Primary outcomes

1

Description
Compelet remission
Timepoint
7days and 14 days after treatment
Method of measurement
Evauation of clinical symptom's remission with questionnaire

2

Description
Vaginal Culture Results
Timepoint
Before and 7 Day Aftar intervention
Method of measurement
Esmear Vaginal

3

Description
Vaginal pH
Timepoint
Before and 7 day After intervention
Method of measurement
By pH meter strips

Secondary outcomes

empty

Intervention groups

1

Description
walnut green husk vaginal cream once applicator a day for 1 week + Cap Fluconazole 100 mg Once a days for 7 day
Category
Treatment - Drugs

2

Description
walnut green husk vaginal cream once applicator a day for 1 week + placebo Cap Once a days for 7 day
Category
Treatment - Drugs

3

Description
cap Fluconazole 100 mg Once a days for 7 day + placebo,vaginal cream,once applicator a day for 1 week.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
East's number one health center in Ahvaz
Full name of responsible person
Masumeh Yaralizadeh
Street address
7 tir park opposite, Ayatollah Behbahani superhighway
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr.Seyed Ahmad Hosseini
Street address
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, opposite the central building, Golestan Blvd.
City
Ahvaz
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, Ahvaz JundiShapur 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
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Salimeh Nezamivand Chegini
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
nezamivndsalime@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masumeh Yaralizadeh
Position
Master of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
Yaralizadeh.m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Yaralizadeh Masumeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences,Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
Web page address
Yaralizadeh.m@ajums.ac.ir

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
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