Investigation the effect of the Deo Drug anti fungal pan-gel on the external genital itching and burning following candidias vaginitis comparing to clotrimazole : a randomized contorted trial
The current study is a prospective, randomized, controlled trial performed on women with Candida infection. This study will be conducted at the Ruin Tan Arash Hospital, Tehran, Iran. After written informed consent is obtained, patients will be allocated randomly to vaginal cream1% and Deo drug pan jell or control group using a random number sequence. Randomization will be done by using an online randomization program, with the use of permuted blocks with a random block size of 6 patients per block. Women in the intervention group will be used clotrimazol vaginal cream1% and Deo drug pan jell for external use. Women in the controlled group will be used clotrimazol vaginal cream1% as well as intervention group and for external use, they use clotrimazol topical cream. Duration of intervention in two groups will be 2 weeks. Clinical improvement of symptoms will be recorded in the form of clinical assessments and pelvic exams by gynecologist. As well as patient satisfaction of treatment, Dosage and duration of treatment will be recorded in the pre-designed forms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080829255N1
Registration date:2017-06-24, 1396/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-24, 1396/04/03
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nictin Drug Industry
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of the Deo Drug anti fungal pan-gel on the external genital itching and burning following candidias vaginitis comparing to clotrimazole : a randomized contorted trial
Public title
The effect of Deoderag pan jell on external genital itching and burning in women with Candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria of this study is marital statues, confirmed clinical diagnosis of candida vulvovaginitis, chief compliant of external symptoms and signs of vulvovaginitis, no usage of herbal medicine or any chemical antibiotics especially in the recent two weeks, no history of AUB, no usage of vaginal douching in the past 48 hours.
Exclusion criteria of this study are overt diabet melitus, Immunosuppressive diseases,Vaginal drugs usage (as creams or gels) during the 4 weeks prior to study pregnancy, menopause, cervicitis, positive history of candidiasis more than 3 times per recent year, abnormal pap smear per recent year,having more than one sexual partner, and PID.
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
168
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 the Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St
City
Tehran
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.TUMS.REC.1395.2757
Health conditions studied
1
Description of health condition studied
Candidiasis
ICD-10 code
N77.1*
ICD-10 code description
Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
Primary outcomes
1
Description
Clinical signs of candidia vaginitis
Timepoint
before and afert the intervention
Method of measurement
clinical pelvic exam observationform
2
Description
Clinical symptoms experienced by the patient
Timepoint
from the begining of the intervention untill finished it
Method of measurement
dailty patenit cheklist
Secondary outcomes
1
Description
recurrence of the vaginitis
Timepoint
4 weeks after the treatment
Method of measurement
recurrence evaluation form
2
Description
level of drug use satisfaction
Timepoint
after the intervention
Method of measurement
drug use satisfaction form
Intervention groups
1
Description
Women in the intervention group will be used clotrimazol vaginal cream1% for internal use and Deo drug pan jell for external use. Duration of intervention will be 2 weeks. The clotrimazol vaginal cream1% must be inserted into the vagina using the applicator provided, applied to the inside areas of the vagina. The Deo drug pan jell must be inserted into the vagina using the applicator provided, applied to the outside areas of the vagina. /
Category
Treatment - Drugs
2
Description
Women in the controlled group will be used clotrimazol vaginal cream1% as well as intervention group and for external use, they use clotrimazol topical cream. Duration of intervention will be 2 weeks. The clotrimazol vaginal cream1% must be inserted into the vagina using the applicator provided, applied to the inside areas of the vagina. The clotrimazol topical cream must be inserted into the vagina using the applicator provided, applied to the outside areas of the vagina.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nictin drug industry
Full name of responsible person
Ali Mohammad Eskandari
Street address
Mottahari st, Torkamanestan st, Ahmadyar avenue, P 21
City
Terhran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nictin drug industry
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Raziyeh Maasoumi
Position
Pos.doc of Sexology, PhD of Reproductive Health, Assisstent Professor of Reproductive Health Departm
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tohid sq
City
Tehran
Postal code
Phone
+98 21 6105 4214
Fax
Email
r_masoumi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Raziyeh Maasoumi
Position
Post.doc of Sexology, PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculity of Nursing and Midwifery, Tohid sq
City
Tehran
Postal code
Phone
+98 21 6105 4214
Fax
Email
r_masoumi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Raziyeh masoomi
Position
assistant professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)