The aim of the present clinical trial study is comparison effect of Curcumin (The active ingredient of Turmeric) and Clotrimazole vaginal cream in treatment vulvovaginal candidiasis . This study will be done as a single blind randomized controlled clinical trial among 94 married women 18-45 years old. Blinding for patients will be carried out. Inclution criteria : presence of the signs and symptoms of vulvovaginal candidiasis in medical history and positive laboratory tests (smear and culture from vaginal discharge); only sexual partner; Not being pregnancy or lactation; Women that don’t use oral contraceptive pills; Not having chronic disease (diabetes, deficiency of immune system, recurrence of vulvovaginal candidiasis ,..); Not having any vaginal bleeding؛ not having Trichomoniasis and bacterial vaginosis. 94 married women eligible for the study of vaginal discharge, itching, and burning, Complain and positive fungal culture, by random sampling method will be divided into 2 groups: 1) curcumin vaginal cream 10% , 2) clotrimazole vaginal cream 1% . The patients will use the drugs for 7 nights in one applicator (5 gram). The patient will back in 4-7 days after treatment for reexamination and evaluation of the clinical signs and symptoms and sampling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111330874N1
Registration date:2016-12-27, 1395/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Nilufar Abuali
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3424 3273
Email address
abuali.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of Curcumin (The active ingredient of Turmeric) and Clotrimazole vaginal cream in treatment vulvovaginal candidiasis.
Public title
The effect of Curcumin vaginal cream in treatment vulvovaginal candidiasis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being married؛ only sexual partner؛ Age between 18 -45؛ Body Mass Index< 30؛ signs and symptoms of vulvovaginal candidiasis, positive Gram staining smear and culture from vaginal discharge.
Exclusion criteria: being pregnancy, lactation and menopausal period; having any vaginal bleeding; recurrent vulvovaginal candidiasis (4 or more vulvovaginal candidiasis in a year); consumption of immunosuppressive drug; women who had used antibiotic for 2 weeks before the study; history of epilepsy, diabetes, heart disease, high blood pressure, thyroid diseases؛ women who had used other vaginal creams or suppositories for 1 week before the study; women who had used systemic antifungal drugs for 4 weeks before the study; existence of other vaginal infections; consumption of oral contraceptive.
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:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Sciences.
Street address
Ground Floor, Department of Research and Information Technology Jundishapur University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
AJUMS.REC.1395.511
Health conditions studied
1
Description of health condition studied
vulvovaginal candidiasis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
vaginal discharge
Timepoint
Baseline, 4-7 days after treatment
Method of measurement
Clinical Examination, observation, and medical history
2
Description
itching
Timepoint
Baseline, 4-7 days after treatment
Method of measurement
history
3
Description
vulva and vaginal Erythma
Timepoint
Baseline, 4-7 days after treatment
Method of measurement
Clinical Examination
4
Description
vulva and vaginal burning
Timepoint
Baseline, 4-7 days after treatment
Method of measurement
history
5
Description
vaginal discharge culture results
Timepoint
Baseline, 4-7 days after treatment
Method of measurement
vaginal discharge culture
6
Description
Compelet remission
Timepoint
4-7 days after treatment
Method of measurement
Evauation of clinical symptom's remission and negetive result of vaginal discharge culture
Secondary outcomes
1
Description
side effects
Timepoint
4-7 days after treatment
Method of measurement
question of patient
Intervention groups
1
Description
curcumin vaginal cream10% , one applicator per day for 1 week.
Category
Treatment - Drugs
2
Description
Clotrimazole vaginal cream1%, one applicator per 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
Nilufar Abouali
Street address
7 tir park opposite, Ayatollah Behbahani superhighway
City
Ahvaz
2
Recruitment center
Name of recruitment center
Gynecology clinic of Imam Khomeyni Hospital
Full name of responsible person
Nilufar Abouali
Street address
Imam Khomeyni Hospital,Azadegan Sq., Ahvaz.
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. Behzad Sharif Makhmal Zadeh
Street address
Vice chancellor for research, Opposite the central building, 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
Jondishapour University of Medical Sciences
Full name of responsible person
Dr.Zahra Abbaspoor
Position
Ph.D in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
1579461357
Phone
+98 61 3373 8331
Fax
Email
www.Abbaspoor-z762@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jondishapour University of Medical Sciences
Full name of responsible person
De.Zahra Abbaspoor
Position
Ph.D in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
6135715749
Phone
+98 61 3373 8331
Fax
Email
www.Abbaspoor-z762@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jondishapour University of Medical Sciences
Full name of responsible person
Dr.Zahra Abbaspoor
Position
Ph.D in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
6135715749
Phone
+98 61 3336 7543
Fax
Email
www.Abbaspoor-z762@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)