Evaluation of the Arnebia Euchroma effectiveness on Candida Vulvovaginitis
Design
This is a clinical trial with 60 patients sample size. Eligible patients will be enrolled after obtaining consent form, randomly assigned, into two groups. Sama Vaginal Cream is manufactured by Mashhad School of Pharmacy Lab. In this study the Patient, the Mycologist and the Analyzer will not know the type of drug that used. For this purpose, two type of drug are placed in similar tubes.
Settings and conduct
Eligible patient will be enrolled into two groups after obtaining consent form. At the beginning and at the end of treatment, vaginal discharge specimens are taken from the patient in the central laboratory of Mashhad Imam Reza Hospital to investigate the presence of a candida in direct slide and culture. The second visit is made two days after the start of treatment to evaluate the side effects of the medication. If cases has complication with herbal medicine, the treatment will switch to standard treatment. On the seventh day after treatment, patients will be examined and a sample of discharge will be taken for laboratory examination. The result is based on clinical observation and laboratory specimen. In this stage, if no response to treatment in intervention group, standard treatment will be considered.
Participants/Inclusion and exclusion criteria
All patients with Candida Vulvovaginitis who are not pregnant, comorbidity such as Diabetes , Hypertention and etc. or medications are included in the study.
Intervention groups
group 1: Prescribing Sama Vaginal Cream one applicator each night for seven days
group 2: Prescribing Clotrimazole Vaginal Cream one applicator each night for seven days
Main outcome variables
Age; Presence of infection; Hypersensitivity; Abdominal cramp; Dyspareunia; Dysuria; frequency ; Study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190303042889N2
Registration date:2021-04-04, 1400/01/15
Registration timing:retrospective
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Zahra Habibian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3221 4363
Email address
habibiannezhadz971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2019-10-22, 1398/07/30
Trial completion date
2019-10-30, 1398/08/08
Scientific title
A comparetive study of Arnebia Euchroma Vaginal Cream and Clotrimazole Vaginal Cream’s effectiveness on Candida Vulvovaginitis
Public title
A comparetive study of Arnebia Euchroma Vaginal Cream and Clotrimazole Vaginal Cream’s effectiveness on Candida Vulvovaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candida Vulvovaginitis
Exclusion criteria:
Pregnancy
Comorbidity
Medication
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Cases, Mycologist and Analyzer won't know about type of drugs; Therefore two types of drug have been placed in the same tubes. After completing the research, based on the color of the substance in the tube, the researcher will identify the type of drug in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical,Daneshgah Ave.,Mahhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
IR.MUMS.REC.1392.127
Health conditions studied
1
Description of health condition studied
Candidiasis Vulvuvaginitis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Candidiasis Vulvuvaginitis in direct smear of vaginal discharge
Timepoint
Baseline and the end of the treatment
Method of measurement
Presence of Candida in direct smear of vaginal discharge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of vaginal ointment 1% aqueous extract of Onosma dichroanthum Boissmade in Mashhad School of Pharmacy, one applicator a day for 7 days
Category
Treatment - Drugs
2
Description
Intervention group: Use clotrimazole vaginal ointment 1% once a day for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Health Center No. 2
Full name of responsible person
Seyedeh Zahra Habibiannezhad
Street address
Mashhad Health Center No. 2, Vahdat Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9153913153
Phone
+98 51 3365 3000
Email
Ch-mashhad2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Mashhad University of Medical Sciences, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
4900
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zhahra HabibianNejad
Position
Phamily Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No 11, Etemad Ave, Khosravi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9136964795
Phone
+98 51 3221 4363
Email
Habibiannezhadz971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zhahra HabibianNejad
Position
Family Medicine Student
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No 11, Etemad Ave, Khosravi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9136964795
Phone
+98 51 3221 4363
Email
Habibiannezhadz971@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyede Zhahra HabibianNejad
Position
Family Medicine Student
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No 11, Etemad Ave, Khosravi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9136964795
Phone
+98 51 3221 4363
Email
Habibiannezhadz971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Variables related to cases such as age can be shared
When the data will become available and for how long
12 months after the article was published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It can be accessed when needed for project design
From where data/document is obtainable
By sending a request to the researcher's email
What processes are involved for a request to access data/document
After emailing the request, the information will be emailed after maximum two weeks