The effect of vaginal consumption of vitamin C supplementation on the improvement of the role of metronidazole in the treatment of patients with bacterial vaginitis
Improving the treatment of bacterial vaginitis using Vitamin C
Design
Clinical trail have two parallel double-blind randomized group
Settings and conduct
This study will be make in Imam Reza Clinic of Kashan University of Medical Sciences in order to evaluate the vitamin c in improvement of bacterial vaginitis that paints randomized two group of vitamin c and placebo and will be evaluated for clinical and laboratory symptoms before and after treatment.
Participants/Inclusion and exclusion criteria
Include:women with bacterial vaginitis base on clinical symptoms and laboratory findings
Exclude:
Patients with immunodeficiency or HIV positive women with genital and urinary tract infections.
Menstruation at the time of attendance.
Pregnancy.
Vitamin C sensitivity
Women who do not allow pelvic examination.
Taking any vaginal drugs, antibiotics, and immune-suppressing drugs and exogenous hormones, including oral contraceptives, during the 2 weeks prior to the study.
Having intercourse or using vaginal douche within the last 24 hours
Intervention groups
Intervention group treated with metronidazole orally twice daily (morning and night) for 7 days with vaginal suppository containing 250 mg vitamin C for 7 days.
Control group treated with metronidazole orally twice daily (morning and night) for 7 days with placebo suppository for 7 days.
Main outcome variables
Changes in the clinical symptoms and direct smear of the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160905029710N2
Registration date:2020-01-29, 1398/11/09
Registration timing:registered_while_recruiting
Last update:2020-01-29, 1398/11/09
Update count:0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Mehdi Nazeri
Name of organization / entity
Department of Medical Parasitology and Mycology, Medical faculty, kashan university of medical scien
Country
Iran (Islamic Republic of)
Phone
+98 31 5555 1112
Email address
nazeri_me@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-18, 1398/10/28
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vaginal consumption of vitamin C supplementation on the improvement of the role of metronidazole in the treatment of patients with bacterial vaginitis
Public title
Effect of vaginal consumption of vitamin C supplementation in the treatment bacterial vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with bacterial vaginitis base on clinical symptoms and laboratory findings
Exclusion criteria:
Patients with immunodeficiency or HIV positive
Women with genital and urinary tract infections
Menstruation at the time of attendance
Pregnant
Vitamin C sesitivity
Women who do not allow pelvic examination
Taking any vaginal drugs, antibiotics, and immune-suppressing drugs and exogenous hormones, including oral contraceptives, during the 2 weeks prior to the study.
Having intercourse or using vaginal douche within the last 24 hours
Age
From 18 years old to 50 years old
Gender
Female
Phase
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 will be done by simple method and using random numbers generated by computer software (Stat Trek software). In this method the computer selects random numbers. with consideration of numbers, the two groups are randomized.Patients are divided into two groups of 30 intervention and 30 control groups and both groups are blinded to complementary therapy.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo will be used to achieve participants,Care provider and investigators will be masking. The researchers and patients will be concealed until the final analyses by a trained staff
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2019-12-02, 1398/09/11
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.101
Health conditions studied
1
Description of health condition studied
Bacterial Vaginitis
ICD-10 code
B96
ICD-10 code description
Other bacterial agents as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Bacterial Vaginitis
Timepoint
Clinical signs and bacterial composition of direct smear will be assessed at baseline (before intervention) and 7 days after administration of Vitamin C.
Method of measurement
Questionnaire containing demographic information and clinical symptoms
2
Description
Improve vaginal bacterial composition
Timepoint
Bacterial composition of direct smear at baseline (before intervention) and 7 days after intervention.
Method of measurement
Direct smear assessment before treatment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with bacterial vaginitis treated with vaginal vitamin C 250 mg daily for seven days and clinical and laboratory symptoms will be assessed before and after treatment.
Category
Treatment - Drugs
2
Description
Control group: Patients with bacterial vaginitis treated with placebo daily for seven days and clinical and laboratory symptoms will be assessed before and after treatment.seven days and evaluation of clinical and laboratory symptoms after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic, Beheshti Ave, Kashan
Full name of responsible person
Dr. Zahra Vahedipoor
Street address
Imam Reza Clinic, Beheshti Ave, Kashan
City
Kashan
Province
Isfehan
Postal code
1134845764
Phone
+98 31 5546 6301
Email
zahravahedpoor@g.commail
Web page address
http://kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafshe
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5557 8011
Email
banafshe57@hotmail.com
Web page address
http://kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zahra Vahedipoor
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics and Gynecology, Kashan University of Medical Sciences, Kashan, Iran