Protocol summary

Study aim
Evaluation of the therapeutic effect of mixture of honey and cinnamon vaginal cream with Clotrimazole vaginal cream for refine of sign and symptom in women with vaginal candidiasis
Design
The study is conducted as a randomized triple-blind study with Computer software.The sample size for comparison of two groups determine 100 women are infected with Candidal vulvovaginitis
Settings and conduct
The study is conducted in one of health centers in the city of Hamedan, Hamedan University of Medical Sciences. Clotrimazole vaginal cream and mixture of cinnamon and honey 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 15 to 45 years old, Signs and symptoms of vaginal candidiasis in interviews, observation and being confirmed by laboratory studies, not being pregnant, no previous use of antifungal drugs, lack of use of broad-spectrum antibiotics during the last two weeks, the lack of allergy to honey and cinnamon being non- diabetic, Exclusion criteria include: pregnancy, lactation, menstruation and abnormal uterine bleeding during treatment.
Intervention groups
In this randomized, triple blind clinical trial of 100 women infected with Candidal vulvovaginitis is placed in two groups of Vaginal cream mixed of cinnamon and honey (N =50) and clotrimazole vaginal cream (N = 50). Both groups is treated for 7 days. At the beginning of study, Clinical and laboratory signs and symptoms are registered 4 and 8 days after treatment by questionnaire, observation secretions medium culture results.
Main outcome variables
Refine of sign and symptom vaginal candidiasis : Itching, Irritation, Dysuria, Dyspareunia, Discharge

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180528039889N1
Registration date: 2018-06-18, 1397/03/28
Registration timing: prospective

Last update: 2018-06-18, 1397/03/28
Update count: 0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Tayebeh Rasooli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 6270
Email address
rasooli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Therapeutic Effect of Mixture Honey and Cinnamon Vaginal Cream with Clotrimazole Vaginal Cream for Refine of Sign and Symptom of Vaginal Candidiasis in Women.
Public title
Study of the Effect of Mixture Honey and Cinnamon Vaginal Cream in the treatment of Vaginal Candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15 _45 years Married Not Being Pregnant Not Having Lactation Not Taking Antibiotic Drugs During the 2 Last Weaks Not Taking vaginal Cream During 2 Last Weaks Not Having Medical Disease Not Having Allergy to Honey or Cinnomon Not Taking Oral Contraceptive Confirming Candida Infection Not Having Recurrent Candida Infection
Exclusion criteria:
To Have Tricomona or Gardenella Vaginitis Not Agreeing to Participate in the Study Not Using Drug Having Vaginal Bleeding
Age
From 15 years old to 45 years old
Gender
Female
Phase
0
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with Computer software
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 randomly is assigned to two groups, case and control. Clotrimazole Vaginal cream and Honey and cinnamon 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. Therefore, 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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti Univercity of Medical Science
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.SBMU.PHNM.1396.850

Health conditions studied

1

Description of health condition studied
Candidal Vaginitis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere

Primary outcomes

1

Description
Itching
Timepoint
Before treatment, 4 and 8 day after treatment
Method of measurement
check list

2

Description
Irritation
Timepoint
Before treatment, 4 and 8 day after treatment
Method of measurement
check list

3

Description
Dyspareunia
Timepoint
Before treatment, 4 and 8 day after treatment
Method of measurement
check list

4

Description
Dysuria
Timepoint
Before treatment, 4 and 8 day after treatment
Method of measurement
check list

5

Description
Discharge
Timepoint
Before treatment, 4 and 8 day after treatment
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: mixture honey and cinnamon vaginal cream each night as an applicator (5 gram) inside the vagina for 7 nights including honey 30% and cinnamon 2%.
Category
Treatment - Drugs

2

Description
Control group: Clotrimazole vaginal cream each night as an applicator (5 gram) inside the vagina for 7 nights.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center
Full name of responsible person
Tayebeh Rasooli
Street address
Buali street
City
Hamedan
Province
Hamadan
Postal code
6516683845
Phone
+98 81 3252 6270
Email
rasooli@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti university of medical science, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tayebeh Rasooli
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
DEPARTMENT OF MIDWIFERY, SCHOOL OF NURSING AND MIDWIFERY, SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCE, VALI ASR ST.,NIAYESH HIGH WAY CROSS SECTION,TEHRAN,TEHRAN PROVINCE,IRAN
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+90 813 252 6270
Email
rasooli@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Nahidi
Position
Supervisor of midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
DEPARTMENT OF MIDWIFERY SCHOOL OF NURSING AND MIDWIFERY/ SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCE/ VALI ASR ST./NIAYESH HIGH WAY CROSS SECTION/TEHRAN/TEHRAN PROVINCE/ IRAN
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
nahidi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tayebeh Rasooli
Position
Postgraduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Second floor, Ebnsina Apartment, Mirfendereski Ally, Buali Street
City
Hamedan
Province
Hamadan
Postal code
6516683845
Phone
+98 81 3252 6270
Fax
Email
rasooli@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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