A comparative study of vaginal cream Clotrimazol and different dosage of vaginal ointment Myrtus on treatment of Candida Vaginitis in women refer to the Khoramabad Asali Hospital
Objectives: The aim of this study is to compare the efficacy of two drugs, vaginal cream clotrimazol and different dosage of vaginal ointment myrtus (2.5%, 5% and 7%) on treatment of vaginal candidiasis.
Objectives: The aim of this study is to compare the efficacy of two drugs, vaginal cream Clotrimazol and different dosage of vaginal ointment Myrtus (2.5%, 5% and 7%) on treatment of vaginal candidiasis
Design: Prospective cohort study.
Setting and conduct: 240 patients with positive culture of vaginal discharge due to candidiasis enrolled in this study. This study was conducted in Khoramabad Asali Hospital, Iran.
Participants including major eligibility criteria: Inclusion criteria include 18-50 years women with positive culture of vaginal discharge due to candidiasis and exclusion criteria include of patients with Age less than 18 and more than 50 years old; pregnancy; diabetes; corticosteroid therapy and antibiotic therapy in two weeks ago.
Intervention: The patients were randomly divided to four groups. Each group included 60 patients. Group A (received vaginal cream Clotrimazol1%), group B (received vaginal ointment Myrtus 2.5%), group C (received vaginal ointment Myrtus 5%) and group D received vaginal ointment Myrtus 7% for 7 days. Clinical symptoms of patients and microbiological evaluation before and after of treatment were prescribed.
Main outcome measures (variables): The effect of different dosage of vaginal ointment Myrtus (2.5%, 5% and 7%) on treatment of vaginal candidiasis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810111744N4
Registration date:2013-12-07, 1392/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-07, 1392/09/16
Registrant information
Name
Soheila Akbari
Name of organization / entity
Lorestan Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 66 1225 0368
Email address
akbari.s@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan Khorraman Herb Company
Expected recruitment start date
2013-03-05, 1391/12/15
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of vaginal cream Clotrimazol and different dosage of vaginal ointment Myrtus on treatment of Candida Vaginitis in women refer to the Khoramabad Asali Hospital
Public title
The effect of vaginal ointment Myrtus on Candida Vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-50 years women with positive culture of vaginal discharge due to candidiasis
Exclusion Criteria: Age less than 18 and more than 50 years old; pregnancy; diabetes; corticosteroid therapy and antibiotic therapy in two weeks ago.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
------------------
Secondary trial Id
--------------
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Vice chancellor for research, Lorestan University of Medical Sciences, 3rd floor, Pardis(Kamalvand)University complex, 3 km. road Khoramabad Borojerd, Khoramabad
City
Khoramabad
Postal code
381351698
Approval date
2012-12-29, 1391/10/09
Ethics committee reference number
79123/200
Health conditions studied
1
Description of health condition studied
candidiasis vaginitis
ICD-10 code
n76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
The assay of effective dosage of vaginal ointment of Myrtus on treatment of candidiasis vaginitis
Timepoint
Before and a week after of tial
Method of measurement
Questioner, examination and culture of vaginal discharge
Secondary outcomes
1
Description
Failure of treatment
Timepoint
A week after trial
Method of measurement
Questioner, examination and culture of vaginal discharge
Intervention groups
1
Description
The patients with candidiasis vaginitis were treated with vaginal cream Clotrimazol 1% for a week.Improvement of clinical symptoms and microbiological evaluations were carried out.
Category
Treatment - Drugs
2
Description
The patients with candidiasis vaginitis were treated with vaginal ointment Myrtus 2.5% for a week. Improvement of clinical symptoms and microbiological evaluations were carried out.
Category
Treatment - Drugs
3
Description
The patients with candidiasis vaginitis were treated with vaginal ointment Myrtus 5% for a week. Improvement of clinical symptoms and microbiological evaluations were carried out.
Category
Treatment - Drugs
4
Description
The patients with candidiasis vaginitis were treated with vaginal ointment Myrtus 7% for a week. Improvement of clinical symptoms and microbiological evaluations were carried out.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences
Full name of responsible person
Soheila Akbari
Street address
Lorestan University of Medical Sciences, Pardis(Kamalvand) university complex, 3 km. road Khoramabad Borojerd, Khoramabad
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Lorestan University of Medical Sciences
Full name of responsible person
dr Mohammad hasan Kaedi
Street address
Vice chancellor for research, Lorestan University of Medical Sciences, 3rd floor, Pardis(Kamalvand)University complex, 3 km. road Khoramabad Borojerd, Khoramabad
City
Khoramabad
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, Lorestan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
khorraman herbal company
Full name of responsible person
dr. ali saleh
Street address
Industrial Estate No.1, khorramabad
City
khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
khorraman herbal company
Proportion provided by this source
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
Lorestan University of Medical Sciences
Full name of responsible person
Akbari Soheila
Position
Obstetric and Gynecologist
Other areas of specialty/work
Street address
Unit 5, 3rd floor, Yas bldg, Laleh St. Jandarmery Sq. Khoramabad, Iran
City
Khoramabad
Postal code
6815854395
Phone
+98 66 1225 0368
Fax
+98 66 1225 0367
Email
dr_akbari_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Akbari Soheila
Position
Obstetric and Gynecologist
Other areas of specialty/work
Street address
Unit 5, 3rd floor, Yas bldg, Laleh St. Jandarmery Sq. Khoramabad, Iran
City
Khoramabad
Postal code
6815854395
Phone
+98 66 1225 0368
Fax
+98 66 1225 0367
Email
dr_akbari_s@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Akbari Soheila
Position
Obstetric and Gynecologist
Other areas of specialty/work
Street address
Unit 5, 3rd floor, Yas bldg, Laleh St. Jandarmery Sq. Khoramabad, Iran
City
Khoramabad
Postal code
6815854395
Phone
+98 66 1225 0368
Fax
+98 66 1225 0368
Email
dr_akbari_s@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)