Comparison of vaginal Bon Sorkh with clotrimazole on treatment of vulvovaginal candidiasis.
Design
Sham controlled clinical trial with a parallel group design, Randomised
Settings and conduct
All married women at reproductive age referring to women's clinics of Ahvaz Razi Hospital who complained for vaginal infections were considered as the population under study.
The sample size in this study was determined 50 people in each group.
The first group which included 50 patients nightly used 1% clotrimazole vaginal cream (Raha Pharmaceutical Co.) with an applicator for 7 days.
The second group which included 50 patients nightly applied - 3% Bon sorkh vaginal cream with an applicator for 7 days.
Participants/Inclusion and exclusion criteria
They were not at pregnancy or breast-feeding stage and did not consume alcohol.
They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study.
They had not previously suffered from known medical diseases such as diabetes, immune system attenuating diseases (such as AIDS) or auto-immune diseases, coagulation disorders, and epilepsy.
Intervention groups
The first group which included 50 patients nightly used 1% clotrimazole vaginal cream (Raha Pharmaceutical Co.) with an applicator for 7 days.
The second group which included 50 patients nightly applied - 3% Bon sorkh vaginal cream with an applicator for 7 days.
Main outcome variables
Vaginal discharge, Pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161031030595N2
Registration date:2018-03-17, 1396/12/26
Registration timing:prospective
Last update:2018-03-17, 1396/12/26
Update count:0
Registration date
2018-03-17, 1396/12/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 300 1511
Email address
shirani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-14, 1397/01/25
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Bon Sorkh vaginal gel with vaginal cream of clotrimazole on treatment of vulvovaginal candidiasis
Public title
Comparison of vaginal Bon Sorkh with clotrimazole on treatment of vulvovaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They were not at pregnancy.
They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study
Exclusion criteria:
They had not previously suffered from known medical diseases such as diabetes, immune system attenuating diseases (such as AIDS) or auto-immune diseases, coagulation disorders, and epilepsy.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
5794-61357
Approval date
2016-09-27, 1395/07/06
Ethics committee reference number
IR.AJUMS.REC.1395.374
Health conditions studied
1
Description of health condition studied
Vulvovaginal Candidiasis
ICD-10 code
N77.1
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginal discharge
Timepoint
Initially, four and eight days after treatment
Method of measurement
Self-administered questionnaire
Secondary outcomes
1
Description
Pruritus
Timepoint
Initially, four and eight days after treatment
Method of measurement
Self-administered questionnaire
Intervention groups
1
Description
In the control group, clotrimazole vaginal cream
Category
Treatment - Drugs
2
Description
In the intervention group, vaginal gel bonsorkh
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Razi Hospital
Full name of responsible person
Heibatullah Kalantari
Street address
Amanieh St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5925
Email
mshirani86@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Badavi Mohhamad
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
mshirani86@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Heibatullah kalantari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 986133738378
Fax
Email
kalantari-h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Heibatullah Kalantari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+61 33738380
Fax
Email
kalantari-h@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shirani Maryam
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Fax
Email
mshirami86@yagoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available