Protocol summary
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Study aim
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Evaluating the effectiveness of thymol vaginal cream on improving symptoms in patients with bacterial vulvovaginitis
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Married women with bacterial vulvovaginitis
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Intervention groups
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Patients with bacterial vulvovaginitis in one group were treated with topical thymol vaginal cream and in the other group were treated with metronidazole tablets.
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Main outcome variables
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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
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Reason for update
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The ethics code was entered incorrectly, and now the correct code is registered.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-08-14, 1401/05/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-23, 1401/06/01
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Expected recruitment end date
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2022-11-22, 1401/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluation of the effects of thymol vaginal cream on bacterial vulvovaginitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-10, 1398/12/20
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Ethics committee reference number
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IR.SSU.MEDICINE.REC.1401.073
Health conditions studied
1
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Description of health condition studied
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Bacterial vulvovaginitis (Trichomonas vaginalis)
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ICD-10 code
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A59.01
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ICD-10 code description
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Trichomonal vulvovaginitis
Primary outcomes
1
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Description
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Complaints and clinical observations
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Timepoint
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Evaluation of complaints and clinical observations on days 1, 3 and 7 days after starting the use of thymol vaginal cream.
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Method of measurement
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Likert scale
Secondary outcomes
1
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Description
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Clinical observations and complaints
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Timepoint
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At the beginning of the study and after days 1, 3 and 7 days after starting to use the vaginal cream
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Method of measurement
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Likert scale
Intervention groups
1
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Description
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Intervention group: patients with bacterial vulvovaginitis treated with topical thymol vaginal cream 5 mg, every night for up to one week.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients with bacterial vulvovaginitis treated with metronidazole 500 mg tablets twice a day for up to one week
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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There is no further information
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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There is no further information
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From where data/document is obtainable
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Mohsen Zabihi
Professor of Pharmacology, Yazd University of Medical Sciences
+98 913 153 6813
mzabihi100@gmail.com
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What processes are involved for a request to access data/document
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Comments
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