The purpose of this randomized controlled trial is to compare the effect of vaginal garlic, thyme and Metronidazole creams in fungal treatment. The study will be performed on all women with vaginosis bacterial symptoms who refer to a clinic associated with Shiraz University of Medical Sciences.
The researcher will first ask the patient to fill a consent form and then complete the initial questionnaire that contains questions about demographic and fertility. Also, the check list of vaginosis bacterial detection will filled by examination and interview. Vaginal discharge Amesel test will be sent to medicine laboratory for review.
Finally, 120 women with positive Amsel test and positive secretion culture for vaginal bacterial and negative secretion culture for Candidiasis and Trichomonasis will be chosen. Then, using a table of random numbers computed by randomized block permutation, they will be divided into two groups, A and B. Women in group A, will take medicine A and women in group B will take medicine B. A week after the treatment, all the patient will be interviewed and samples will be taken and the vaginal samples will be analyzed using Amsel subculture method to assess clinical improvement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062718187N2
Registration date:2014-07-22, 1393/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-22, 1393/04/31
Registrant information
Name
Sedighe Forouhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 987136474257
Email address
foruharis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Shiraz University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparision of the effects of Micosin vaginal cream and Metronidazole vaginal gel on treatment of bacterial vaginosis
Public title
Effects of vaginal cream, Garlic, Thyme and Metronidazole in Bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Those who are willing to cooperate; Married women of reproductive age (18 to 44 years old); Positive, Gram staining of bacterial vaginosis; Bacterial vaginosis symptoms on clinical examination; Non-current use of anti-parasitic drugs, antibiotics, immunosuppressive drugs and vaginal medications during the past two weeks; Lack of abnormal uterine bleeding; Not having recurrent vaginitis (4 or more than 4 times a year) ;No pregnancy; No breastfeeding; No use douching frequently; No alcohol and anticoagulant coumarin; No cases of multiple sex partners; No getting certain diseases, such as liver disease, diseases of the central nervous system, blood Dyscrasia, diabetes, immune deficiency; No history of allergy to mint category and garlic taken orally or topically.
Exclusion criteria: Sensitivity to the drug and non-drug use; taking any prescribed medications with conflicting effect with medicines in this study; taking any drug that affect vaginosis symptoms and treatment; lack of patients interest
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Shiraz University of Medical Sciences
Street address
Research Deputy, Shiraz University of Medical Science
City
Shiraz
Postal code
1978-71345
Approval date
2014-03-19, 1392/12/28
Ethics committee reference number
CT-92-6941
Health conditions studied
1
Description of health condition studied
Vginosis Bacterial
ICD-10 code
N76.8
ICD-10 code description
Other specified inflammation of vagina and vulva
Primary outcomes
1
Description
Treatment of bacterial vaginosis in the two groups (vaginal cream, garlic and thyme Vmtrvnydazvll)
Timepoint
One week after the end of treatment
Method of measurement
Czech List, examination, testing Amsel
Secondary outcomes
empty
Intervention groups
1
Description
A 50-gram tube of vaginal cream, garlic and thyme in a week by the samples will be used for the treatment of bacterial vaginosis.
Category
Treatment - Drugs
2
Description
0.75 mg vaginal gel metronidazol a week by the sample will be used for the treatment of bacterial vaginosis.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic in Shiraz
Full name of responsible person
Maryam Asadi, Student of Msc in Midwifery
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed basir hashemi
Street address
Technology and Research Office, Research Deputy , Shiraz University of Medical Science, Zand Street, Shiraz
City
shize
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Sedighe Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
shiraz
Postal code
71345-1978
Phone
+98 71 1647 4257
Fax
+98 64 74252
Email
forouharism@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
Sedighe Foruhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4257
Fax
+98 64 74252
Email
forouharism@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Foruhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4257
Fax
+98 64 74252
Email
forouharism@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)