Background: Vaginitis is the commenest reason for gynecological consultation in women of childbearing age. Due to the side effect of chemical drugs try to find safe drug with more effect is one of the treatment purposes. Honey is a curative element in herbal extracts has various applications which it is anti-fungial property has been proved. This study was carried out to compare to therapeutic effect of honey vaginal jel with clotrimazole vaginal cream for treatment of volvovaginit candidiasis.
Methods:This study was a single-blind randomized clinical trial that conducted on 106 patients at fertility age for three steps. From the viewpoint of clinical complaints and laboratory culture. All the patients were diagnosed to be affected and underwent treatment in two groups of 53 individuals each with clotrimazole and honey randomly. The results were compared after 8 days of therapy and reculturing.a p-value of<0.05 was considered statistically significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604144317N9
Registration date:2016-06-28, 1395/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-28, 1395/04/08
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
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of honey vaginal jel with clotrimazole
vaginal cream for treatment of vol vovaginit candidasis
Public title
Comparison of the therapeutic effect of honey vaginal jel with clotrimazole
vaginal cream for treatment of vol vovaginit candidasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non-pregnant women who had not used immune suppressors, or broad spectrum antibiotics in the last month, and had no history of epilepsy, diabetes, cardiac diseases, hypertension, thyroid diseases, or advanced arthritis.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences-International Branch
Street address
Shahid Beheshti University of Medical Sciences, Beside Hemat Bridge, Shahid Abbaspoor Avenue, Vali Asr Avenue
City
Tehran
Postal code
Approval date
2015-01-05, 1393/10/15
Ethics committee reference number
1000/2577
Health conditions studied
1
Description of health condition studied
Vulvovaginal candidiasis
ICD-10 code
N77.1
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginal discharge
Timepoint
First, 4th and 8th day after treatment
Method of measurement
Self- making questionnaire
Secondary outcomes
1
Description
Vaginal irradiation
Timepoint
First, 4th and 8th day after treatment
Method of measurement
Self- making questionnaire
2
Description
Itching
Timepoint
First, 4th and 8th day after treatment
Method of measurement
Self- making questionnaire
Intervention groups
1
Description
In intervention group Honey vaginal gel for 8 days
Category
Treatment - Drugs
2
Description
Iin control group clotrimazole vaginal cream for 8 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences Shahriyar Health Center
Full name of responsible person
Zahra Seifinadergoli
Street address
Number 36, Saba St., Tohid Avenue, Yaghchian
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, 2nd SBUMS Bldg., Next to Ayatollah Taleghani Hospital, Evin,Tehran, Iran
City
Tehran
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
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
Department of Midwifery and Reproductive Health of Shahid Beheshti University of Medical Sciences, F
Full name of responsible person
Nahid Fatemeh
Position
PhD, Head of Midwifery group
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Faculity of Midwifery & Nursing
City
Tehran
Postal code
Phone
+98 21 2243 9912
Fax
+98 21 2243 9912
Email
nahidifateme@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculity of Midwifery & Nursing
Full name of responsible person
Nahidi Fatemeh
Position
PhD, Head of Midwifery and Reproductive Health
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Faculity of Midwifery & Nursing
City
Tehran
Postal code
Phone
+98 21 2243 9912
Fax
Email
nahidifateme@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculity of Midwifery & Nursing
Full name of responsible person
Nahidi Fatemeh
Position
PhD
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Faculity of Midwifery & Nursing
City
Tehran
Postal code
Phone
+98 21 2243 9912
Fax
Email
nahidifateme@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)