Comparison of the therapeutic effect of Honey and Nigella sativa (Dosin) vaginal cream and Clotrimazole vaginal cream in treatment Candida Vulvovaginitis
Evaluation of the therapeutic effect of honey and Nigella Sativa (Dosin) vaginal cream with Clotrimazole vaginal cream in treatment Candida Vulvovaginitis.
Design
The study is conducted as a randomized triple-blind study .The sample size for comparison of two groups determine 84 women are infected with Candidal vulvovaginitis.
Settings and conduct
The study is conducted in Baharloo Hospital in the city of Tehran. Clotrimazole vaginal cream and and honey and Nigella Sativa (Dosin) vaginal cream are packaged similarly, and is marked ‘‘B’’ and ‘‘A’’. Samples, researcher, and statistical analysis are unaware of the content of cream. Therefore, the present study is conducted as a Triple-blind study
Participants/Inclusion and exclusion criteria
Exclusion criteria include :being at age of 18 to 49 years old, Not being pregnancy,Not being lactation, Not Having Allergy to Honey or Nigella Sativa or Clotrimazole,Not being period, Not using vaginal cream and vaginal doush and for last 48 hours before the study, Not using vaginal cream and vaginal doush and for last 48 hours before the study,Not Having recurrent Candida vaginitis (4 or more Candida vaginitis in a year), Not Having of history of curettage, Hysterosalpingography and uterine surgery in the last two weeks, No history of receiving blood or chemotherapy in a recent month,Having of signs and symptoms of Candida vaginitis, positive direct smear and culther of vaginal discharge, Exclusion criteria include:Not Agreeing to Participate in the Study, The use of antibiotics to treat non-vaginitis systemic infections during treatment, Participation at another trial, Pregnancy in the study time table
Intervention groups
One group ( honey and Nigella Sativa (Dosin) vaginal cream ); Another group (Clotrimazole vaginal cream )
Main outcome variables
Outcome of culture of vaginal discharge; fungal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190711044176N1
Registration date:2019-07-26, 1398/05/04
Registration timing:registered_while_recruiting
Last update:2019-07-26, 1398/05/04
Update count:1
Registration date
2019-07-26, 1398/05/04
Registrant information
Name
Seyedeh Tahereh Mirmolaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mirmolaei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of Honey and Nigella sativa (Dosin) vaginal cream and Clotrimazole vaginal cream in treatment Candida Vulvovaginitis
Public title
Therapeutic effects of Dosin (Nigella sativa and Honey) vaginal Cream on Candida Vulvovaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women were married and aged between 18-49 years old
Not being pregnancy
Not being lactation
Not Having Allergy to Honey or Nigella Sativa or Clotrimazole
Not being period
Not using vaginal cream and vaginal doush and for last 48 hours before the study
Not Having of history of diabetes and deficiency of immune system
Not Having recurrent Candida vaginitis (4 or more Candida vaginitis in a year)
Not Having of history of curettage, Hysterosalpingography and uterine surgery in the last two weeks
No history of receiving blood or chemotherapy in a recent month
Having of signs and symptoms of Candida vaginitis, positive direct smear and culther of vaginal discharge
Exclusion criteria:
Not Agreeing to Participate in the Study
The use of antibiotics to treat non-vaginitis systemic infections during treatment
Participation at another trial
Pregnancy in the study time table
Age
From 18 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient is asked to fill out the letter of consent to participate in the study and simple randomly is assigned to two groups, case and control. Clotrimazole Vaginal cream and Honey and Nigella Sativa Vaginal cream are packaged similarly and is marked "A" and "B" by a pharmacist.Creams are applied each night as an applicator (5 g) inside the vagina for 7 nights. Samples, research group, and statistical analysis are unaware of the content of cream. the present study is conducted as a Triple-blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics Commitee of the Faculty of Nursing and Midwifery,Tehran University of Medical Science
Street address
PO Box 6459,Dr Mirkhani St.(Eastern Nusrat),Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-07-09, 1398/04/18
Ethics committee reference number
IR.TUMS.FNM.REC.1398.074
Health conditions studied
1
Description of health condition studied
Candida VulvoVaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina (N77.1*)
Primary outcomes
1
Description
Symptoms and signs of Candida Vulvovaginitis
Timepoint
Before intervention, 6-10 day after treatment
Method of measurement
Questionnaire,Microscopic evaluation,Secretion culture,Measurements Of Ph
Secondary outcomes
1
Description
Improve Of Candida Vulvovaginitis
Timepoint
6-10 Day After Treatment
Method of measurement
Questionnaire, culther
Intervention groups
1
Description
Intervention group: Intervention group: honey and Nigella Sativa"Dosin" vaginal cream each night as an applicator inside the vagina for 7 nights.
Category
Treatment - Drugs
2
Description
Control group: Control group: Clotrimazole vaginal cream each night as an applicator inside the vagina for 7 nights.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo Hospital Gynecology Clinic
Full name of responsible person
Masoumeh Norouzi
Street address
Baharloo Hospital - Behdari.st - Railway.sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4215
Email
Norouzi7378@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
No23, Valiasr Avenue, Dameshgh Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۷۱
Phone
+98 21 8163 3685
Email
norouzi7378@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Norouzi
Position
Master of Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
PO Box 6459,Dr Mirkhani St.(Eastern Nusrat),Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4215
Email
norouzi7378@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyedeh Tahereh Mirmolaei
Position
Phd in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
East Nosrat Avenue, Towhid square, Nursing and Midwifery Faculty, Tehran University Of Medical Science
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4215
Email
mirmolaei@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Norouzi
Position
Student Master Of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Faculty,Tehran University of Medical Sciences,East Nosrat Avenue.Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4215
Email
norouzi7378@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
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