The comparison of the effect of oral Garlic tablets(Garsin); and Fluconazole in the treatment of vaginal candidiasis in women referred to Kuhdasht city health- medical centers in 1390
Vaginitis is the most prevalent gynecological problem for women that look for treatment and is responsible for 10 millions physician visits annually. Use of herbal treatments has been recorded in many of patient groups as well as in general populations to increase health level. The present study has conducted with the purpose of determination and comparison of the effect of oral garlic tablets(garsin) and Fluconazole for the treatment of vaginal candidiasis in reefrred women to Kuhdasht health medical center in 1390.
This clinical trial is a prospective, multivariate, two-stage, two-group study in health medical centers in Kuhdasht in 2011 and it performs among 110 married women 18-44 years with complains of vaginal itching or irritation. Vulvovaginal candidiasis diagnoses through pH value vaginal discharge and direct microscopy examination and culture in agar sabouraud. Patients are divided to two randomized groups (55 members in each group) after exactly diagnose. patients in Garsin group and Fluconazole receive 3 doses 500mg Garsin tablet for 7 days and single dose 150 mg Fluconazole respectively .Then patients were checked 4- 7 days after completion of the treatment period and the side-effects were registered. Data collection was accomplished demographic information questionnaire and clinical performance checklist, and these data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111193226N3
Registration date:2012-07-16, 1391/04/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-16, 1391/04/26
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-02-25, 1390/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of oral Garlic tablets(Garsin); and Fluconazole in the treatment of vaginal candidiasis in women referred to Kuhdasht city health- medical centers in 1390
Public title
The effect of oral Garlic tablets(Garsin); and Fluconazole in the treatment of vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women were 18-44 years old and were married; They had a single sexual partner and they themselves were the only sexual partner of their respective spouse; They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study; They did not suffer from trichomonal vaginitis, bacterial vaginitis, or cervicitis based on direct smear, which was controlled by examining the patient's discharge; They were not at pregnancy or breast-feeding stage; They were not menopause (priority of not being menopause was higher than age criterion, i.e. They must have been non-menopause even if they were younger than 49 years old); They had not previously suffered from known medical diseases such as diabetes, immune system attenuating diseases (such as AIDS) or use of immunosuppressive drugs, auto-immune diseases, coagulation disorders, and epilepsy; They were not menstruated, and had no bleeding or breakthrough bleeding when they visited the clinics; candidiasis culture was in agreement with clinical symptoms and patient's complaints.
Exclusion ceiteria: pregnancy in study time table; emergency use of antibiotic in study time and druges intulerance.
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran highway- Yaman street- next to Taleghani hospital-
City
Tehran
Postal code
1985717443
Approval date
2011-05-01, 1390/02/11
Ethics committee reference number
99
Health conditions studied
1
Description of health condition studied
vaginal candidiasis
ICD-10 code
b37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginitis
Timepoint
Four to 7 days ofter completion of the treatment period
Method of measurement
Accomplished demographic information questionnaire and clinical performance checklist, clinical observation-pH value vaginal discharge and direct microscopy examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention-3 doses 500mg meal Garsin tablet for 7 days
Category
Treatment - Drugs
2
Description
Control- single dose 150 mg Fluconazole meal capsule
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Rasoul Allah (PBUH) Hygienic and Medical Center
Full name of responsible person
Dr. Aminizade Hhasan
Street address
Clinical and treatment net of Kuhdasht- Farmandari square
City
Kuhdasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Massome Simbar
Street address
Shahid Chamran highway- Yaman street- next to Taleghani hospital-Shahid Beheshti University of Medical Sciences
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
Clinical and treatment net
Full name of responsible person
Ebrahimi-Farzaneh
Position
Sc.midwifery
Other areas of specialty/work
Street address
Farmandari squre
City
Kuhdasht
Postal code
Phone
+98 66 3624 0671
Fax
Email
farzanehebrahimy@gmil.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
Dolatian Mahrokh
Position
Msc of Midwifery
Other areas of specialty/work
Street address
Vali asr street- Nyayesh junction- Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
mdolatian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical and Treatment Net
Full name of responsible person
Ebrahimi Farzaneh
Position
Sc of Midwifery
Other areas of specialty/work
Street address
Farmandari Squer
City
Kuhdasht
Postal code
Phone
00
Fax
Email
Farzanehebrahimi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)