Investigating the effect of herbal vaginal pills based on pomegranate peel on treatment of bacterial vaginosis referred to bessat clinic compaird to metronidazole , a double blind clinical trial
Evaluation the effectiveness of herbal vaginal product based on pomegranate peel on the treatment of bacterial vaginosis in women referring to clinics in Kerman.
Design
This study is a double-blind randomized clinical trial, and patients are assigned to two groups using the permutation random block method in blocks of 4.
Settings and conduct
The study is conducted on married women suffering from bacterial vaginosis who refer to the clinics of Kerman city. that a group of herbal medicine and a group of metronidazole take, and for the purpose of blinding, the drugs are prepared in the same form and packaging.
Participants/Inclusion and exclusion criteria
inclusion Criteria:
1. Married women aged 18 to 50
2. Declaration of readiness to refer for necessary examinations and treatment measures
3. Signs and symptoms of bacterial vaginosis
4. Declaring consent to participate in the research and signing the informed consent form
Exclusion criteria:
1. Withdrawal from participating in the research
2. Drug sensitivity
3. The development of any complications during treatment
4. Presence of pregnancy
5. Complicated and recurrent bacterial vaginosis infection diagnosed by a gynecologist
6. The presence of underlying diseases (diabetes, kidney, heart, liver, etc.)
7. Use of immunosuppressants or the presence of immunodeficiency disease
8. Use of hormonal contraceptive methods
9. Taking antibiotics two weeks before sampling and at the same time as taking medicine
10. Simultaneous use of other vaginal creams or suppositories
Intervention groups
Herbal vaginal product based on pomegranate peel
Main outcome variables
Outcome measures were burning, itching, malodor, abnormal vaginal discharge, pH, clue cell and Positive whiff test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240511061746N1
Registration date:2024-06-20, 1403/03/31
Registration timing:prospective
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
zarrin sarhady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3133 6163
Email address
z.sarhady@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of herbal vaginal pills based on pomegranate peel on treatment of bacterial vaginosis referred to bessat clinic compaird to metronidazole , a double blind clinical trial
Public title
Evaluation the effect of herbal vaginal pills based on pomegranate peel on treatment of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bacterial vaginosis symptoms
Exclusion criteria:
pregnancy
Patients with chronic diseases
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
permutation randomized block and in blocks of 4, permutation random block table for two groups based on which patients are assigned to two groups using software
R software has been prepared (A is the control group and B is the intervention group)
B A
A A
A B
A A
B B
A A
B B
B B
B A
A B
B A
A A
B B
B A
B B
A A
B B
A B
A B
A A
B A
A B
B A
A A
B B
B B
A B
A A
A B
Blinding (investigator's opinion)
Double blinded
Blinding description
First, the drugs of the two intervention and control groups are packaged by the pharmacist in dark-colored cans of the same shape and coded after labeling. Then the drug packages are given to the researcher in such a way that neither the patient nor the researcher He does not know the contents inside the package.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of afzalipour hospital- kerman university of medical science
Street address
Emam Khomeini highway, afzalipour hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2024-01-27, 1402/11/07
Ethics committee reference number
ir.kmu.ah.rec.1402.180
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
Acute vagi
ICD-10 code description
N76.0
Primary outcomes
1
Description
, pH, clue cell and Positive whiff test.
Timepoint
Before treatment and one week after treatment
Method of measurement
1) paper ph meter 2) whiff test using 10% KOH solution
Secondary outcomes
1
Description
سوزش، خارش، بوی بد، ترشحات غیر طبیعی واژن
Timepoint
Before treatment and one week after treatment
Method of measurement
Vaginal examination and patient's statements during history taking
Intervention groups
1
Description
Intervention group: Herbal vaginal product based on pomegranate peel
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besaat clinic
Full name of responsible person
Sareh sadat ebrahimi
Street address
Ebn sina
City
Kerman
Province
Kerman
Postal code
1677
Phone
+98 34 3132 5700
Email
Besaat@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin iranpour
Street address
Ibn sina, kerman university of medical sciences
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
Vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zarrin Sarhadynejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Haft baghe_alvi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 6163
Email
zsarhady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zarrin Sarhadynejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Haft baghe alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 6163
Email
zsarhady@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zarrin Sarhadynejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Haft baghe alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 6163
Email
zsarhady@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the information at this time
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Through the email of the person responsible for the general or scientific response of the study
When the data will become available and for how long
After printing and publishing the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
On the condition of maintainig trust and citation
From where data/document is obtainable
Correspond with the email of who responsible for the public or scientific response of this study
What processes are involved for a request to access data/document
Correspond with the email of the person responsible for the general or scientific response of the study