Compare the effect of Havachobe herbal root (Arnebia euchroma) with colotrimazole 1% vaginal on improving Volvo vaginal candidia
Design
Clinical trial with community-based and pragmatic control group, with parallel, double-blind, randomized
Settings and conduct
Researchers will be diagnosed into two intervention and control groups after diagnosis of candidal vaginitis by physician and specialized gynecologic clinic in simple random and double blind (researchers and subjects) will be divided into intervention and control groups.peapole who are being subjected to intervention from a violet drug and control subjects will use a standard colotrimazol drug of 1%.
Participants/Inclusion and exclusion criteria
Conditions for admission: Presence of vaginitis / non-admission: presence of other vaginitis, history of chronic illness and antibiotic use
Intervention groups
People who have candidate vaginitis after clinical and laboratory examinations will be considered as a group.
married
Presence of candida vaginit infection in interview and confirmation with laboratory study
Exclusion criteria:
The presence of vaginal Simultaneous
Sensitivity to colotrimazole cream
Abnormal vaginal bleeding
Pregnancy
Use of immunsuppressive drugs and antibiotics, corticosteroid and birth control pills
Cure chronic diseases such as diabetes, heart disease, and high blood pressure. thyroid disorder and Epilepsy
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Random randomization based on simulated random codes
Blinding (investigator's opinion)
Double blinded
Blinding description
Two blinds Blinding will be done in the researcher and the research unit
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shushtar faculty of medical sciences
Street address
faculty of medical sciences shushtar. Alhade hospital. Rajae BLV. Shushtar
City
shushtar
Province
Khouzestan
Postal code
6461899968
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.SHOUSHTAR.REC.96.01
Health conditions studied
1
Description of health condition studied
volvovaginitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improve symptoms and severity
Timepoint
Before the start of the study, 7 and 30 days after the start of treatment with aphrodisiac (Abuhlsa) and coltrimazole 1%
Method of measurement
Clinical symptoms, Pap smear and culture of vaginal discharge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
women clinic Emam Khomaini
Full name of responsible person
Zahra Sadat Pazhohideh
Street address
Between BLV Salehi and 24 metre street
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3222 2922
Email
pajohidehz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Sadat Pazhohideh
Street address
faculty medical of sciences shoushtar. Alhadi Hospital. Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3622 8926
Email
pajohidehz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Sadat Pazhohideh
Position
master of sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty medical of sciences shoushtar. Alhadi Hospital. Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3622 8926
Email
pajohidehz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Sadat Pazhohideh
Position
master of sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty medical of sciences shoushtar. Alhadi Hospital. Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3622 8926
Email
pajohidehz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Sadat Pazhohideh
Position
master of sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
faculty medical of sciences shoushtar. Alhadi Hospital. Rajaie BLV
City
Shoushtar
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3622 8926
Email
pajohidehz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The part of the data includes information about the main consequences or the like it is possible to share
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions will be available
Under which criteria data/document could be used
از این داده ها جهت بررسی عفونت قارچی در سایر قسمت های بدن از جمله پوست و مو استفاده کرد
87/5000
The data was used to check fungal infections in other parts of the body, including skin and hair
From where data/document is obtainable
By receiving the email of the responsible author at pajohidehz@gmail.com
What processes are involved for a request to access data/document
After requesting data by email, the data will be sent within 1-2 weeks