The purpose of this randomized double blind study will be to determine the effects of Cinnamon zeylanicum capsules and Clotrimazole vaginal cream on the treatment and relapse of Candida vaginitis in Tehran.
120 patients will be randomly divided into two groups: intervention (capsules Cinnamon and Clotrimazole vaginal cream) and control (placebo and Clotrimazole vaginal cream). The patients use (500 mg capsules of cinnamon three times a day (morning, noon, night) with clotrimazole vaginal cream1 % One applicator of cream will be used at bed time for one week) and the other group ( 400 mg capsules of starch powder three times a day with clotrimazole vaginal cream1%) over one weeks. Patients will be followed 3-4 days after the beginning of the treatment and will be returned in 4-3 days after the end of the treatment for reexamination and evaluation of the clinical signs and sampling and the next 14 days for the recurrence evaluation and sampling
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206104317N7
Registration date:2012-07-26, 1391/05/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-26, 1391/05/05
Registrant information
Name
Fatemeh Nahidi
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 982188202512
Email address
nahidi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Expected recruitment start date
2012-05-11, 1391/02/22
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Cinnamon zeylanicum capsules and Clotrimazole vaginal cream on the treatment and relapse of Candida Vaginitis in Tehran.
Public title
The effects of Cinnamon zeylanicum capsules and Clotrimazole vaginal cream on the treatment and relapse of Candida Vaginitis in Tehran.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being Iranian; Being married ; Age between 15 or 45; Positive wet smear of vaginal discharge; Not being pregnancy, lactation and menopausal period; Not having any vaginal bleeding; Not having chorionic disease (diabetes, HIV,…); Women that hadn’t history of using antibiotic for 2 weeks before; Women that don’t use oral contraceptive pills; Not being overweight (Body Mass Index>29); Not having intercourse and vaginal douching during the last24 hours; Not using any antifungal drugs, for 2 weeks before the study; Not using vaginal cream for last 48 hours before the study; Not having allergy with herbal drugs
Exclusion criteria: Having Trichomoniasis and bacterial vaginosis; Having allergy with herbal drugs; Having gastric ulcer
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti University of Medical Sciences and Health Services
Street address
Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-04-30, 1391/02/11
Ethics committee reference number
777-114-01-1390
Health conditions studied
1
Description of health condition studied
Candida vaginitis
ICD-10 code
N77.1
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
2
Description of health condition studied
Candida vaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Treatment
Timepoint
Before treatment -3-4 days after the beginning of treatment - 14-days aftertreatment
Method of measurement
Information form
2
Description
Recurrence
Timepoint
14 days after treatment and 8 weeks after treatment for the recurrence
Method of measurement
Wet smear and Culture
Secondary outcomes
empty
Intervention groups
1
Description
The patients in intervdntion group use 500 mg capsules of cinnamon three times a day (morning, noon, night) with clotrimazole vaginal cream1 %. One applicator of cream was used at bed time for one week
Category
Treatment - Drugs
2
Description
The patients in placebo group use 400 mg capsules of starch powder three times a day(morning, noon, night) with clotrimazole vaginal cream1%.One applicator of cream use at bed time for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Medical & Educational Center
Full name of responsible person
Fatemeh Nahidi and Roya Najafi
Street address
Madani Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Ira
Full name of responsible person
DR.Seyed Farsad Hosseini Shirazi
Street address
Vali-e-asr Ave., Southwest of Niayesh junction, P.O.Box:14155-3817
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Ira
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
Shahid Beheshtii University of Medical Sciences
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member of Shahid Beheshti University of Medical Sciences , MSc in Midwifery and PhD candidat
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences. Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 2243 9912
Fax
Email
f.nahidi87@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member , MSc in Midwifery and PhD candidate in Health Education and Promotin
Other areas of specialty/work
Street address
Women’s affairs Office, Shahid Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4421 8052
Fax
Email
nahidifateme@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member , MSc in Midwifery and PhD candidate in Health Education and Promotin
Other areas of specialty/work
Street address
Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+212 122439912
Fax
Email
f.nahidi87@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)