The purpose of this study is to determine the comparison of vaginal cream Artemisia with Clotrimazole in the treatment of vaginal candidiasis. It is a random triple-blind study, which will be undertaken on 60 patients, complaining of symptoms of vulvovaginal candidiasis, after confirmation of the disease by wet smear and culture, patients will be divided into two treatment groups and will be treated with Artemisia vaginal cream (30 individuals) and Clotrimazole (30 individuals) for seven days. Patients will be examined one week ± 24 hours after the treatment through discharge culture and wet smear. In this study, recovery means the reduction of clinical signs of the disease and the negative tests of discharge culture and wet smear.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121831454N1
Registration date:2017-06-07, 1396/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Ala Sabermohammad
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 918 750 3539
Email address
saberma921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two vaginal cream Artemisia kulbadica and clotrimazole in treatment of vaginal candidiasis
Public title
Comparison of two vaginal cream Artemisia and clotrimazole in treatment of vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signs and symptoms of Candida vaginitis؛ positive culture and wet smear of vaginal discharge. Exclusion criteria: pregnancy؛ hypersensitivity to clotrimasol or artemisia؛ recurrent Candida vaginitis (4 or more Candida vaginitis in a year)؛ consumption of immunosuppressive drugs or systemic antibiotics؛ history of diabetes؛ using vaginal creams 2 weeks prior to the study؛ consumption of systemic anti-fungal drugs during 2 weeks prior to the study؛ presence of non-candidia vaginitis؛ consumption of oral contraceptives.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
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
Table of random numbers
Secondary Ids
1
Registry name
In yet another center
Secondary trial Id
In yet another center
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
DoktoVice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Next to the Hoveyzeh cinema, Mashhad ra Intersection, Mashhad
City
Mashhad
Postal code
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
IR.MUMS.REC.1395.385
Health conditions studied
1
Description of health condition studied
vulvovaginit candidiasis
ICD-10 code
n77.1*
ICD-10 code description
Vulvovaginal ulceration and inflammation in diseases classified elsewhere
Primary outcomes
1
Description
Discharge
Timepoint
Baseline, 1 week+_24 hours after treatment
Method of measurement
Clinical Examination, observation, and medical history
Secondary outcomes
1
Description
Pruritus
Timepoint
Baseline, 1 week+_24hours after treatment
Method of measurement
History
2
Description
Erythema symptoma
Timepoint
Baseline, 1 week _+24 hours after treatment
Method of measurement
Observation, and History
3
Description
Dysuria
Timepoint
Baseline, 1 week+_24 hours after treatment
Method of measurement
History
4
Description
Dysparonia Symptom
Timepoint
Baseline, 1 week+_ 24hours after treatment
Method of measurement
History
5
Description
Vaginal Culture
Timepoint
Baseline, 1 week+_24 hours after treatment
Method of measurement
Vaginal Culture
Intervention groups
1
Description
Intervention group: treatment with vaginal cream 0/1% Artemisia- Built in the Pharmacy School of Mashhad University of Medical Sciences-one applicator every night for a week-Intervention group
Category
Treatment - Drugs
2
Description
Control group: Treatment with vaginal cream Clotrimazole 1%- production of Aboreahan company-an applicator every night for a week-control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baze Sheakh, health Cente
Full name of responsible person
Ala sabermohammad
Street address
Street Poursina 32, Street Baze Sheakh,Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Tager Abad, health center
Full name of responsible person
Ala sabermohammad
Street address
Tajer Abad health center, Street Tajer Abad, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences - Deputy of Research and Technology
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
ViceVice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Next to the Hoveyzeh cinema, MashhadIran Chancellor for Research and Technology University of Mashhad, Mashhad University of Medical Sciences, vice-chancellor for Research and Technology.
City
Mashhad
Grant name
......
Grant code / Reference number
......
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences - Deputy of Research and Technology
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
School of Nursing and Midwifery
Full name of responsible person
Ala sabermahammad
Position
MSc student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina st., Doctora cross way, Daneshgah Avenue, Mashhad Mashhad
City
Mashhad
Postal code
Phone
+98 51 3750 3539
Fax
+98 51 3589 1511
Email
saberma921@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
Samira Ebrahimzadeh Zagamy
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Street. Ibn Sina,Crossroads doktora,University Avenue.mashhad.
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
+98 51 3859 1511
Email
saberma921@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
omid kiani
Position
Student of Biostatistics
Other areas of specialty/work
Street address
School of Public Health, University 18,University Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3851 5116
Fax
+98 51 3851 5116
Email
kianibo911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)