Evaluation of the effectiveness of Thymol vaginal cream on improving symptoms in patients with bacterial vulvovaginitis; A double-blind randomized clinical trial
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General information
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The ethics code was entered incorrectly, and now the correct code is registered.
The ethics code was entered incorrectly, and now the correct code is registered.
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کد اخلاق اخذ شده اشتباه وارد شده بوده است و اکنون کد صحیح ثبت شد
کد اخلاق اخذ شده اشتباه وارد شده بوده است و اکنون کد صحیح ثبت شد
Evaluating the effectiveness of thymol vaginal cream on improving symptoms in patients with bacterial vulvovaginitis
Design
A clinical trial with a control group, with a parallel group, double-blind, randomized, phase two, on 60 patients. Random using the RND function of Excel software
Settings and conduct
Venue: Yazd Research Institute of Reproductive Sciences
How to conduct: The study will be conducted on 60 patients with bacterial vulvovaginitis (Trichomonas vaginalis) (diagnosis based on clinical examination or testing of vaginal secretions). Patients are randomly divided into intervention (thymol) and control (metronidazole) groups. Medicinal items will be placed in sealed and numbered boxes at the disposal of doctors and patients. Patients will be evaluated on days 1-3-7.
Participants/Inclusion and exclusion criteria
Married women with bacterial vulvovaginitis
Intervention groups
Patients with bacterial vulvovaginitis in one group were treated with topical thymol vaginal cream and in the other group were treated with metronidazole tablets.
Main outcome variables
Clinical complaints (itching, foul-smelling discharge, vaginal irritation and burning, pain during intercourse, and pain in the lower abdomen)
Clinical observations (inflammation of the appearance of the cervix, inflammation of the appearance of the vagina, homogeneity of secretions, abnormality of the amount of secretions, and the color of secretions)
The occurrence of complications
General information
Reason for update
The ethics code was entered incorrectly, and now the correct code is registered.
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N12
Registration date:2022-08-14, 1401/05/23
Registration timing:prospective
Last update:2022-10-08, 1401/07/16
Update count:1
Registration date
2022-08-14, 1401/05/23
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
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
Evaluation of the effectiveness of Thymol vaginal cream on improving symptoms in patients with bacterial vulvovaginitis; A double-blind randomized clinical trial
Public title
Evaluation of the effects of thymol vaginal cream on bacterial vulvovaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female
Married
Patients with bacterial vulvovaginitis based on ASMEL criteria
Willingness to participate in the study and complete the ethical consent form
Exclusion criteria:
Irritation or allergic reaction to the drug
Aggravation of symptoms caused by infection
Not taking medicine for more than one day
Women who are pregnant, breastfeeding, have immune deficiency or malignancy
History of mental disorders and psychosis
Allergic reactions following consumption of thymol or products containing thymol
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization (patients will be selected in blocks of 5)
Randomization Unit: Person
Randomization tool: Sealed envelopes
To concealing random allocation will use Sequentially numbered, sealed, opaque envelopes (SNOSE).
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be done in a double-blind manner.
Patients, clinical caregiver (doctor) and evaluator (doctor) will not know about the intervention.
Worms will be provided to the caregiver and the patient in identical boxes with numbers one and two written on them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Prof. Hessabi Ave.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1401.073
Health conditions studied
1
Description of health condition studied
Bacterial vulvovaginitis (Trichomonas vaginalis)
ICD-10 code
A59.01
ICD-10 code description
Trichomonal vulvovaginitis
Primary outcomes
1
Description
Complaints and clinical observations
Timepoint
Evaluation of complaints and clinical observations on days 1, 3 and 7 days after starting the use of thymol vaginal cream.
Method of measurement
Likert scale
Secondary outcomes
1
Description
Clinical observations and complaints
Timepoint
At the beginning of the study and after days 1, 3 and 7 days after starting to use the vaginal cream
Method of measurement
Likert scale
Intervention groups
1
Description
Intervention group: patients with bacterial vulvovaginitis treated with topical thymol vaginal cream 5 mg, every night for up to one week.
Category
Treatment - Drugs
2
Description
Control group: Patients with bacterial vulvovaginitis treated with metronidazole 500 mg tablets twice a day for up to one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Dr. Leila Zanbag
Street address
Timsar Fallahi Ave.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 7085
Email
yazd-rsi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Prof. Hessabi Ave.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 1171
Email
mzabihi100@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Prof. Hessabi Ave.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 1171
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
891678477
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
There is no further information
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
Mohsen Zabihi
Professor of Pharmacology, Yazd University of Medical Sciences
+98 913 153 6813
mzabihi100@gmail.com
What processes are involved for a request to access data/document