The aim of this study was to comparing the effect of Lawsonia inermis (henna) vaginal cream with clotrimazole vaginal cream on treatment and relapse of candida vaginitis This randomized, double-blind study is carried out at East Ahvaz number one health center. Inclusion criteria: sign and symptoms of vulvovaginal candidiasis, married women between 18-45 years old, patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse. Exclusion criteria: women who had used antibiotics, immunosuppressive drugs, or any vaginal drugs 14 days before the study; pregnancy; breast feeding; diabetes and immunodeficiency side effects of the drug. 75 married women eligible for the study of vaginal discharge, itching, and burning. . . complain and positive fungal culture, by random sampling method divided into 2 groups: 1) Lawsonia inermis (henna) vaginal cream and 2) clotrimazole vaginal cream. Physical examination, vaginal pH and vaginal smear measured before and after interventions will be compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022119743N4
Registration date:2016-03-06, 1394/12/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-06, 1394/12/16
Registrant information
Name
Masumeh Yaralizadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
yaralizadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-12-31, 1395/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Lawsonia inermis (henna) vaginal cream with clotrimazole vaginal cream on treatment and relapse of candida vaginitis
Public title
The effect of Lawsonia inermis (henna) vaginal cream on treatment of candida vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sign and symptoms of vulvovaginal candidiasis; married women between 18-45 years old; patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse. Exclusion criteria: women who had used antibiotics, immunosuppressive drugs, or any vaginal drugs 14 days before the study; pregnancy; breast feeding; diabetes and immunodeficiency side effects of the drug.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Ahvaz Jundishapur University of Medical Science
Street address
Ground Floor, Department of Research and Information Technology University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
AJUMS.REC.1394.616
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
Compelet remission
Timepoint
Seven and 14 days after treatment
Method of measurement
Evauation of clinical symptom's remission with questionnaire
Secondary outcomes
1
Description
Vaginal pH
Timepoint
Before intervention and 7 days after intervention
Method of measurement
By pH meter strips
2
Description
Vaginal culture results
Timepoint
Before intervention and 7 days after intervention
Method of measurement
Vaginal smear
Intervention groups
1
Description
Clotrimazole vaginal cream once applicator a day for 1 week
Category
Treatment - Drugs
2
Description
Lawsonia inermis (henna) vaginal cream once applicator a day for 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
East's number one health center in Ahvaz
Full name of responsible person
Masumeh Yaralizadeh
Street address
7 tir park opposite, Ayatollah Behbahani superhighway
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Opposite the central building, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz JundiShapur 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
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Salimeh Nezamivand Chegini
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
yaralizadeh.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masumeh Yaralizadeh
Position
Master of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
Yaralizadeh.m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Yaralizadeh Masumeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
00986133367543
Phone
+98 61 3336 7543
Fax
Email
Yaralizadeh.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)