- Determination and comparison of the frequency of positive Amsel criteria (KOH test, PH test, presence of clinical symptoms, smear test) before and after treatment in two groups
- Comparison of frequency of complications and complaints (inflammatory and allergic reactions, dryness, itching) of patients after treatment and comparison of two groups
Design
This study is the third phase of a triple-blind randomized clinical trial that will be conducted on 106 female patients with bacterial vaginosis. The selection of samples from medical centers and obstetrics and gynecology clinics will be convenience, and the allocation of patients to treatment groups will be done by permuted block randomization that used as DOE option in MINITAB software version 15. The treatment period will be 10 days and one pill every day.
Settings and conduct
The study will be conducted on a female patient suffering from bacterial vaginosis, referring to medical centers and specialized gynecology and obstetrics clinics.
Participants/Inclusion and exclusion criteria
• Women aged 18 to 49 who are sexually active
• Bacterial vaginitis has been diagnosed in them.
Proof of bacterial vaginosis in the studied units will be based on Amsel criteria, which has at least 3 of the following 4 cases:
1. Uniform white-yellowish-gray vaginal discharge
2. Vaginal pH greater than 4.5
3. Wif positive test
4. The presence of key cells in the wet smear sample
Intervention groups
The intervention group consisted of recipients of vagiclean vaginal tablets
The control group included the recipients of metronidazole vaginal tablets
Main outcome variables
The result of the wet mount test
KOH test result
Amsel criteria
The symptoms of the disease include vaginal discharge, foul-smelling discharge, itching, pain during intercourse, burning, urinary burning and Lower abdominal pain
General information
Reason for update
Acronym
Vagiclean
IRCT registration information
IRCT registration number:IRCT20220512054829N1
Registration date:2022-09-19, 1401/06/28
Registration timing:registered_while_recruiting
Last update:2022-09-19, 1401/06/28
Update count:0
Registration date
2022-09-19, 1401/06/28
Registrant information
Name
Hossein Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0111
Email address
akbari1350_h@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the vaginal tablet of vagiclean and metronidazole on Bacterial vaginosis
Public title
Comparison of the vaginal tablet of vagiclean and metronidazole on Bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Women in the age range of 18 to 49 years•
Women who are sexually active•
Bacterial vaginitis has been diagnosed in them.
Exclusion criteria:
• Pregnancy and lactation
• The presence of an intrauterine device ,
Use of specific medications such as immunosuppressive drugs and broad-spectrum antibiotics
• Having certain diseases such as liver, nerve, heart, kidney and blood dyscrasias and diabetes
Use of antiprostaglandins
• Complications from drug use or drug allergies
• Vaginal candidiasis and Trichomonas vaginalis
Age
From 18 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by permuted block method so that first all 4 blocks which include two codes A and B (6 blocks) are prepared and numbers from one to 6 are assigned to each. Then, using the table of random numbers of each number 1 to 6 that is selected, the corresponding block of each code will be written (30 blocks). Based on this, a sequence of codes A and B with 80 codes (proportional to the number of samples) is prepared. Then, each of the letters A and B is randomly assigned to one of the drug and placebo groups. The same code is recorded on each drug and will remain with the formulation department until the end of the study. At the end of the study, the drug code in the form of A and B will be provided to the statistical analyst. In this way, both randomization of the study and three-way blinding will be performed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drugs in both groups are in the form of vaginal tablets and are packaged in one-size-fits-all vials in the formulation section of Barij Essential Oil Pharmaceutical Company, then coded based on codes previously prepared using a random number table.
Placebo
Not used
Assignment
Parallel
Other design features
Considering that the treatment period of metronidazole for the treatment of bacterial vaginosis is 5 days and the treatment period of Vagiclean is 10 days. Patients of the first group who will be treated with vagiclean vaginal tablets. These tablets are in two packages of five vials, which are placed on one of the vials marked 'for use for the first five days' and on the other vial marked 'for use on the second five days'. In this way, the patients of the case group receive medicine for ten days. But in metronidazole group, patients receive placebo for 5 days. The purpose of this work was to perform complete blinding.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Kashan University of Medical Sciences
Street address
Ghotb ravandi BLVD, pezeshk street
City
Kashan
Province
Isfehan
Postal code
8715985131
Approval date
2022-05-14, 1401/02/24
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.211
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N70-N77
ICD-10 code description
Inflammatory diseases of female pelvic organs
Primary outcomes
1
Description
bacterial vaginitis
Timepoint
Before intervention, 5th days of intervention, 10th days of intervention
Before intervention, 5th day of intervention, 10th day of intervention
Method of measurement
Observation of symptoms
Intervention groups
1
Description
Intervention group: Vagiclean vaginal tablets
Category
Treatment - Drugs
2
Description
Control group: Metronidazole vaginal tablets
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital of kashan
Full name of responsible person
Hossein Akbari
Street address
Ghotb-e ravandi BLVD, pezeshk street
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5554 0111
Fax
+98 31 5554 0111
Email
akbai1350_h@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
حمید رضا بنفشه
Street address
Ghotb ravandi BLVD, pezeshk street
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5554 0029
Fax
+98 31 5554 0029
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Barij essnce pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hossein Akbari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Ghotb-e ravandi BLVD, pezeshk street
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5558 9057
Fax
+98 31 5554 0111
Email
akbari1350_h@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hossein Akbari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Ghotb ravandi BLVD
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5558 6057
Fax
+98 31 5554 0111
Email
akbari1350_h@yahoo.cim
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hossein Akbari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Ghotb ravandi BLVD
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5554 0111
Fax
+98 31 5554 0111
Email
akbari1350_h@yahoo.cim
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
It is possible to share some of the data
When the data will become available and for how long
The access period begins one year after the publication of the article
To whom data/document is available
All faculty members of medical universities
Under which criteria data/document could be used
If they want to do more accurate statistical analysis on the data
or use newer diagnostic methods to measure the outcome of the intervention
From where data/document is obtainable
Call phon and email
What processes are involved for a request to access data/document
By making a phone call or e-mail to the responsible person and concluding a memorandum of cooperation about the service that is to be provided and the benefit that will reach the parties