Comparison of Salvia Officinalis vaginal cream and clotrimazole in the treatment of vaginal candidiasis in Diabetic women
Design
Clinical trial with a control group, parallel group, non-randomized, and accessible method
Settings and conduct
Emam Reza, Ommolbanin hospital /After confirmation of the laboratory, two groups consume vaginal cream
Participants/Inclusion and exclusion criteria
Diabetic women with candidate vaginitis, having a score of at least 3 of the total score of symptoms of vaginal candida infection in examination and observation / acute stress
Intervention groups
Diabetic women with candida vaginitis include two groups: Salvia Officinalis vaginal cream and clotrimazole who consume one night for 7 nights.
Main outcome variables
Improve vaginal candidiasis symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190221042787N1
Registration date:2019-05-12, 1398/02/22
Registration timing:registered_while_recruiting
Last update:2019-05-12, 1398/02/22
Update count:0
Registration date
2019-05-12, 1398/02/22
Registrant information
Name
Raha Pirouzmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
pirouzmandr961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Salvia Officinalis vaginal cream and clotrimazole in the treatment of vaginal candidiasis in Diabetes women
Public title
The effect of salvia officinalis vaginal cream on vaginitis in diabetic women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent for participation in the study
Have at least reading and writing skills
Resident of Mashhad city
Married and having more than 15 years of ages
Prove diabetes by examining a patient's case
No history of clotrimazole susceptibility
No history of allergy to the lamina family
No pregnancy
Non-Lactation
Lack of menopause
No IUD and Not using hormonal contraceptive methods
Non-use of special medication within the last two weeks
Failure to catch vaginal candida infection more than 4 times a year
Lack of a menstrual period or any vaginal bleeding
Having a score of at least 3 of the total score of symptoms and symptoms of vaginal candida infection during examination and observation
In the examination of the absence of genital tract infections
Positive vaginal discharge culture of a candidate
Not having a medical condition other than diabetes
Lack of acute and new stress in the last 8 weeks
No addiction or hookah smoking
Having a single partner
Failure to perform curettage,Histro Salpango Graphy، surgery in the last two weeks
Not getting blood and Chemotherapy in the last 4 weeks
No use of antifungals to treat Vaginal infection in the last two weeks
Not having sexually transmitted infections in the last month
Exclusion criteria:
Refusal to participate in research by research unit
Having sensitivity to the medicine given
Having acute and severe stress during treatment
Use of certain medication during treatment
The use of an anti fungal drug with a given drug
period monthly or abnormal bleeding during the study
Lack of vaginal cream over one night
Antibiotic therapy during treatment
Use of aromatic and sanitary materials for washing the vagina
Use of herbal remedy or other anti fungal medication (topical or oral) with the medicine given
Age
From 15 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue,Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.089
Health conditions studied
1
Description of health condition studied
vaginal candidiasis Diabetes women
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginal Candidiasis in Diabetes Women
Timepoint
A week± 24 hours
Method of measurement
Culture Discharg In laboratory
Secondary outcomes
1
Description
Itching
Timepoint
Before treatment, a week ± 24 hours after treatment
Method of measurement
Patient's biography
2
Description
Erythema
Timepoint
Before treatment, a week ± 24 hours after treatment
Method of measurement
Clinical examination, observation and patient history
3
Description
Irritation
Timepoint
Before treatment, a week ± 24 hours after treatment
Method of measurement
patient history
4
Description
Painful intercourse
Timepoint
Before treatment, a week ± 24 hours after treatment
Method of measurement
patient history
5
Description
The result of vaginal discharge culture
Timepoint
Before treatment, a week ± 24 hours after treatment
Method of measurement
vaginal discharge culture
Intervention groups
1
Description
Intervention group: Salvia Officinalis Vaginal Cream 2% ,an applicator every night for 7 nights
Category
Treatment - Drugs
2
Description
Control group: clotrimazole vaginal cream1% ,an applicator every night for 7 nights