Among the patients who have the inclusion criteria and accepted being in this study we will select two groups. Group 1: oral lactobacillus acidophilus plus topical &vaginal clotrimazole.Group2: oral placebo plus topical & vaginal clotrimazole. Seven days and 30 days after treatment we will evaluate therapeutic response considering clinical signs and symptoms
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901303756N1
Registration date:2011-07-24, 1390/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Tarlan Hamidehkhoo
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 2114
Email address
drnajafian.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Science
Expected recruitment start date
2011-03-03, 1389/12/12
Expected recruitment end date
2011-07-21, 1390/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the clinical efficacy of the vaginal-topical clotrimazole and oral lactobacillus in treatment of vulvovaginal candidiasis
Public title
Evaluation of the effectiveness of oral lactobacillus acidophillus on treatment of women's yeast infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
married ladies with sign and symptoms of vulvovaginal candidiasis
Exclusion criteria:
pregnancy; breast feeding; side effects of the drug and lack of patient's cooperation in the study
Age
From 15 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
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
Vice-Chancellor For Research, Ahvaz University of Medical Scienses
Street address
Golestan blvd, Daneshgah squar
City
Ahvaz
Postal code
Approval date
2011-02-26, 1389/12/07
Ethics committee reference number
ETH101
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
7days and 30 days after treatment
Method of measurement
Evauation of clinical symptom's remission with questionnaire
2
Description
Relapse of the symptoms
Timepoint
30 days after treatment
Method of measurement
Evaluation of relapsing symptoms after primary remission with questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The patients in intervension group will receive oral probiotic twice daily for 1 month, added to conventional treatment :vaginal-topical clotrimazole for 1 or 2weeks in acute or chronic types respectively .
Category
Treatment - Drugs
2
Description
The patients in control group will recieve vaginal-topical clotrimazole for 1week or 2weeks in acute or chronic types respectively + placebo capsules twice daily for 1month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital of the Ahvaz
Full name of responsible person
Tarlan hamidehkhoo, Resident of Obstetrics & Gyenecology