Protocol summary

Summary
The goal of this study is comparison of Zataria multiflora vaginal cream effect and metronidazol oral tablet on the results of trichomona vaginalis therapy, bacterial vaginiosis and these two infections are with each other. This study was done on 420 stricken women to bacterial vaginosis, trichomonas vaginalis or both of these infections with each other ,that were accidentally placed in 6 groups of 70.the diagnosis criteria are wet smear and gram stain .In the experiment groups Zataria multiflora vaginal cream and plasbo oral tablet and in control groups metronidozal oral tablet and plasbo vaginal cream were advised for 7 days . The comparison of clinical signs therapy percent in each 3vaginitis groups do not show important statistic difference after using Zataria multiflora vaginal cream and metronidozal oral tablet .but the comparison of wet smear results in trichomona groups and bacterial vaginosis along with trichomona were important in both groups CONCLUSION: Zataria multiflora vaginal cream have affected ,similarly to metronidozal oral tablet ,on the therapy of trichomona clinical signs and bacterial vaginosis and also the therapy of bacterial vaginosis and it could be an proper remedy in treatment of bacterial vaginosis and obviating of trichomona vaginalis clinical signs.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110291548N12
Registration date: 2011-11-21, 1390/08/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-11-21, 1390/08/30
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research of Shiraz University of Medical Sciences - barijessence medical company of kashan
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-08-20, 1390/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Zataria multiflora vaginal cream and Metronidazol oral tablet effect on the therapy results of trichomona vaginalis and bacterial vaginosis in women refered to selection departments of Shiraz medical science university
Public title
The comparison of Zataria multiflora vaginal cream and Metronidazol oral tablet effect on the therapy results of trichomona vaginalis and bacterial vaginosis in reproductive women
Purpose
Treatment
Inclusion/Exclusion criteria
Entering criteria into the study were as fallowing : Tending to cooperate ; Reproductive age women Existing criteria are fallowing entries : Having abnormal uterus bleeding ; Frequently vulvovaginits ; pregnancy ; Mensturation ; Lactating ; Use of vaginal douches frequently, consuming remedy for treatment in 3 recent months ; Consumig alcohol and anti coagulation remedies and recent consuming anti-parasite remedy, anti-biotic, weakening remedy of safety system and vaginalis remedy ;Multi partner ; Stricken to specific diseases like liver diseases ,kidney diseases and central chords system diseases ,blood dyscrasi ,diabetes ,impair of safety system, known sexual transmitted diseases ; President of allergy Labiants in form of larder and locally ; President of allergy in using metronidazol tablet
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 420
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
Ethical committee of Shiraz University of medical sciences
Street address
Namazi squer
City
Shiraz
Postal code
Approval date
2010-12-14, 1389/09/23
Ethics committee reference number
5334-89

Health conditions studied

1

Description of health condition studied
vaginos bactrial and trichomona vaginalis
ICD-10 code
n76.8
ICD-10 code description
n76.8

Primary outcomes

1

Description
gram stian and- wet smear - clinical signs
Timepoint
befor intervention and 2 week after intervention
Method of measurement
question sheet

Secondary outcomes

1

Description
side effects
Timepoint
2 week after intervention
Method of measurement
question sheet

Intervention groups

1

Description
vaginal cream plasbo zataria multiflora vaginal crem zataria multiflora 0.1 % , 50 g , 7 days , 1 applicator 5 g oral tablet plasbo metronidazol
Category
Treatment - Drugs

2

Description
oral tablet metronidazol , 250 mg , 7days q12h two tablet , tehran chemic company
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Zinabeeh Hospital
Full name of responsible person
Dr. Amoee
Street address
Zinabeeh Hospital, Defae moghadas squer, Shiraz, Fars, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Dabaghmanesh
Street address
Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research of Shiraz University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Barijessence Medical Company
Full name of responsible person
Dr Bekhradi
Street address
Barijessence Medical Company
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barijessence Medical Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Abdali
Position
Master of Midwifery, Faculty of the university
Other areas of specialty/work
Street address
College of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 917 717 0129
Fax
Email
abdali-kh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Amoee
Position
Obstetric and Gynecology Physician
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1230 5410
Fax
Email
sedighehamoee@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Univercity of medical sciences
Full name of responsible person
Khadijeh Abdali
Position
Master of midvifery , Faculty of the university
Other areas of specialty/work
Street address
College of nursing and midwifery
City
Shiraz
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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