A vaginal dosage form preparation of Gall and Myrtle and study of theirs effects in bacterial vaginitis via double blind randomized clinical trial with placebo control
In this investigation, the effects of a vaginal dosage form prepared from Gall and Myrtle in compression with placebo on bacterial vaginitis will be evaluated in a parallel study via double blind (patients and researchers) randomized clinical trial.
Main inclusion criteria are patients between 18 and 55 years with symptoms of BV on clinical examination and tests and main exclusion criteria are positive clinical diagnosis but negative tests; pregnancy and breast feeding.
Population study is patients coming to Motahari Polyclinic and request voluntary to include to the study. The number of subjects is 100 that we will include them randomly in to two groups with 50 persons. In one group, after take oral course of metronidazole and ensure the BV cure, subjects use vaginal dosage form. They use this drug sixteen nights.
On the other hand, in the next group, patients use placebo with the same method.
Then clinical examinations and tests will be repeated after 16 and 45 days.
After applying drugs and gathering data, they will be analyzed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030526917N1
Registration date:2016-05-16, 1395/02/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-16, 1395/02/27
Registrant information
Name
Sayyedeh Fatemeh Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1919
Email address
stud0653219921@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2016-09-19, 1395/06/29
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A vaginal dosage form preparation of Gall and Myrtle and study of theirs effects in bacterial vaginitis via double blind randomized clinical trial with placebo control
Public title
effect of Quercus brantii and Myrtus communis suppository on women infection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-55 years, with signs on physical examination and tests,
The lack of recent use of antiparasitic drugs, antibiotics,immunosuppressive drugs and drugs during the past two weeks vaginal, No intercourse and no use of douching in last 48 hours, Lack of abnormal uterine bleeding, Non-pregnant and non-lactating, Not using douches repeatedly, No smoking or alcohol consumption and coumarin anticoagulants, Lack of sensitivity to drug components
exclusion criteria:
Taking any medication affecting drugs, Taking any drug effect on symptoms and treatment of vaginitis, Drug allergy, People who are considered patient based on the clinical diagnosis but based on test results are negative
Age
From 77 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SUMS.REC.1394.219
Health conditions studied
1
Description of health condition studied
Bactrial Vaginitis
ICD-10 code
N76.8
ICD-10 code description
Other specified inflammation of vagina and vulva
Primary outcomes
1
Description
Check cluecells
Timepoint
0, 16th, 45th after intervention
Method of measurement
counting by microscope
2
Description
determination the PpH of vagina
Timepoint
0, 16th, 45th after intervention
Method of measurement
by litmus paper with high precision
3
Description
Whiff test
Timepoint
0, 16th, 45th after intervention
Method of measurement
The smell of ammonia or fish from the discharge after the addition of KOH 10%