Comparison of the effectiveness of salvia officianalis plant, clotrimazole alone and in combination on the improvement and recurrence of candida vaginitis
Aims: the effectiveness of salvia officianalis plant, clotrimazole alone and in combination on the improvement and recurrence of candida vaginitis. Study design: a triple blind randomized controlled trial (the assessor, participants, and data analyzer will be unaware of the type of intervention given to every participant). Study population: women with symptoms of candida vaginalis who will refer to health center of Tabriz University of medical sciences in year 2017. Inclusion criteria: clinical signs of candidal vaginitis; Positive tests for direct observation; Positive discharge cultures, married women. Exclusion criteria: pregnant and lactating and Menopause women; use of vaginal medication in the last two weeks; suffering from autoimmune diseases; Having menstrual bleeding or bleeding between two monthly cycles during a visit; trichomoniasis and Gardnerella positive; occurrence of symptoms of drug allergy. Sample size and studied intervention: 111 persons, three groups of 37 people included: recipient of 400 mg vaginal Salvia officinalis tablet and clotrimazol placebo, recipient of 400 mg vaginal Salvia officinalis tablet and 100 mg vaginal Clotrimazole tablet, recipient of 100 mg vaginal clotrimazol tablet and Salvia officinalis placebo. The intervention time: one week.Study outcome: negative clinical and laboratory findings and clinical complaints one week and 12 week after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020227311N4
Registration date:2017-07-23, 1396/05/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Behnaz Sadeghzadeh Oskouei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 0364
Email address
sadeghzadehb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education, Tabriz University of Medical Sciences
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of salvia officianalis plant, clotrimazole alone and in combination on the improvement and recurrence of candida vaginitis
Public title
Comparison of the effectiveness of salvia officianalis plant, clotrimazole alone and in combination on the improvement and recurrence of candida vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical signs of candidal vaginitis; Positive tests for direct observation; Positive discharge cultures; married; 15-49 years old; Reading and writing literacy herself or a family member; Willingness to participate in the study and Possibility to visit the clinic at the requested time; Having a phone call. Exclusion criteria: pregnant and lactating and Menopause women; use of antibiotics and medications that suppress the immune system (corticosteroids) and the use of vaginal medication in the last two weeks; suffering from autoimmune diseases; chronic disease and hypothyroidism...; Having menstrual bleeding or bleeding between two monthly cycles during a visit; trichomoniasis and Gardnerella positive; use of contraceptive pills and high carbohydrate intake; occurrence of symptoms of drug allergy.
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:
111
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is a triple blind randomized controlled trial using 3 and 6 blocks of 1: 1: 1 ratio in three groups with 37 members.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Postal code
Approval date
2017-06-28, 1396/04/07
Ethics committee reference number
IR.TBZMED.REC.1396.251
Health conditions studied
1
Description of health condition studied
Candidiasis of vulva and vagina
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
Primary outcomes
1
Description
Determine clinical and laboratory results
Timepoint
one and 12 week after treatment
Method of measurement
By signs checklist,wet test,Gram colorin and culture
Secondary outcomes
1
Description
Clinical complaints of patients
Timepoint
One and 12 weeks after starting treatment
Method of measurement
Clinical symptom checklist
Intervention groups
1
Description
The women in intervention group will recipient of 400 mg vaginal Salvia officinalis tablet and clotrimazol placebo once a day for seven day
Category
Treatment - Drugs
2
Description
The women in intervention group will recipient of 400 mg vaginal Salvia officinalis tablet and 100 mg vaginal Clotrimazole tablet once a day for seven day
Category
Treatment - Drugs
3
Description
women in control group wiil recipient of 100 mg tablet vaginal clotrimazol and clotrimazol placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AlzahraTherapeutic Educational Center
Full name of responsible person
Fatemeh Ahangari, MSc Student of Midwifery
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Taleghani Therapeutic Educational Center
Full name of responsible person
Fatemeh Ahangari, MSc Student of Midwifery
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
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, Tabriz 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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
fatemeh ahangari
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati street