The aim of the present clinical trial study is comparison effect of Satureja hortensis L and Clotrimazole vaginal cream in treatment vulvovaginal candidiasis.
Design
In this study 84 Candidial Vulvovaginitis patients who are eligible for inclusion and exclution criteria in the study will be selected.
Settings and conduct
This randomized, double-blind study is carried out at East Ahvaz number one health center.Samples include married women aged 18 to 45 with vulvovaginal candidiasis. The sample size is 84 and the duration of the intervention is 1 weeks. Researcher and volunteer Participation in this study is completely unaware from vaginal medications , and medications tubes fill with pharmacist.Vaginal medications are all in the same package and are coded by the pharmacist. Patients eligible for the study of vaginal discharge, itching, and burning, Complain and positive fungal culture, by random sampling method will be divided into 2 groups: 1) Satureja hortensis L vaginal cream 1% , 2) clotrimazole vaginal cream 1% . The patients will use the drugs for 7 nights in one applicator (5 gram). Physical examination, Vaginal pH and vaginal smear measured before and after interventions and compared in both the group.
Participants/Inclusion and exclusion criteria
Presence of the signs and symptoms of vulvovaginal candidiasis in medical history and positive laboratory tests (smear and culture from vaginal discharge); only sexual partner; Not being pregnancy or lactation; Women that don’t use oral contraceptive pills; Not having chronic disease (diabetes, deficiency of immune system, recurrence of vulvovaginal candidiasis ,..); Not having Trichomoniasis.
Intervention groups
One group (vaginal cream Satureja hortensis L ); Another group((vaginal cream Clotrimazole )
Main outcome variables
Outcome of culture of vaginal discharge; fungal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180202038591N1
Registration date:2018-02-15, 1396/11/26
Registration timing:prospective
Last update:2018-02-15, 1396/11/26
Update count:0
Registration date
2018-02-15, 1396/11/26
Registrant information
Name
shirin jaldani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3447 0943
Email address
shirin.jaldani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-05, 1396/12/14
Expected recruitment end date
2018-09-05, 1397/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Satureja hortensis L. and clotrimazole vaginal cream in treatment of Candida vulvovaginitis
Public title
The effect of Satureja hortensis L. cream in treatment vulvovaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signs and symptoms of vulvovaginal candidiasis
Positive Gram staining smear
Culture from vaginal discharge
Exclusion criteria:
Age between 18 -45
Being married
Only sexual partner
Signs and symptoms of vulvovaginal candidiasis
Positive Gram staining smear
Culture from vaginal discharge
The absence of any known medical condition
Lack of any allergy to coltriamzol cream and Satureja hortensis L
Completion of written consent form for examination and sampling
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The specimens are randomly divided into blocks of block 4 by permutation blocks. The drugs used in this study are randomly assigned by a person outside the study according to the corresponding codes in sealed envelopes, and then assigned to any disease that is included in the study. The drugs are identical in terms of appearance, such as packaging, color. In this way, the researcher and the patient are unaware of the type of drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind study: Researcher and volunteer Participation in this study is completely unaware from vaginal medications , and medications tubes fill with pharmacist.Vaginal medications are all in the same package and are coded by the pharmacist.
Placebo
Not 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
Associate Professor of Research and Information Technology, Ahvaz Jundishapur University of Medical Sciences, Academic town, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.AJUMS.REC.1396.878
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
Vaginal Discharge
Timepoint
Before intervention, 7 days after treatment
Method of measurement
Clinical Examination, Observation and Medical history
2
Description
Itching
Timepoint
Before intervention, 7 days after treatment
Method of measurement
History
3
Description
Vulva and Vaginal Burning
Timepoint
Before intervention, 7 days after treatment
Method of measurement
History
4
Description
Vaginal discharge culture results
Timepoint
Before intervention, 7 days after treatment
Method of measurement
Vaginal discharge culture
5
Description
Compelet remission
Timepoint
Before intervention, 7 days after treatment
Method of measurement
Evauation of clinical symptom's remission and negetive result of vaginal discharge culture
Secondary outcomes
1
Description
Dyspareunia
Timepoint
Before intervention, 7 days after treatment
Method of measurement
History
2
Description
Side Effects
Timepoint
Before intervention, 7 days after treatment
Method of measurement
Question of patient
Intervention groups
1
Description
Intervention group: Satureja hortensis L vaginal cream 1%, one applicator per day for 1 week
Category
Treatment - Drugs
2
Description
Control group: Clotrimazole vaginal cream1%, one applicator per day for 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
East's number one health center in Ahwaz
Full name of responsible person
Shirin Jaldani
Street address
7 Tir park opposite, Ayatollah Behbahani superhighway
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 5633
Email
Shirin.jaldani@gmail.com
2
Recruitment center
Name of recruitment center
Gynecology clinic of Imam Khomeyni Hospital
Full name of responsible person
Shirin Jaldani
Street address
Imam Khomeyni Hospital,Azadegan Sq., Ahwaz.
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
Shirin.jaldani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Vice chancellor for research, Opposite the central building, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 1984
Email
itc@ajums.ac.ir
Web page address
http://behsan.ajums.ac.ir
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
Ahvaz University of Medical Sciences
Full name of responsible person
Shirin Jaldani
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3336 1984
Email
Shirin.jaldani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8396
Email
Javadnoori-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shirin Jaldani
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3636 3453
Email
Shirin.jaldani@gmail.com
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
No - There is not 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