Comparison of the effect of oral tablet of Metronidazole with vaginal cream of Jaft concurrent with oral tablet of Metronidazole on results of Bacterial Vaginosis (BV) management in childbearing age women
Objectives: In this study, the effect of oral tablet of Metronidazole with vaginal cream of Jaft concurrent with oral tablet of Metronidazole on results of Bacterial Vaginosis (BV) management in childbearing age women will be compared; Design: In this Double-blinded (patients and researcher) study, from all the patients referred to the clinic, complaining BV, approximately 950 people will be screened, out of which 168 women with eligible criteria will be randomized into two groups of control and intervention; Setting and Conduct: First, Personal information form and inclusion criteria for the study will be completed, Then the tests for diagnosing BV will be done. Treatment for both groups of control and intervention will be done for 7-10 days and finally the tests will be repeated for comparing the symptoms and outcome; Inclusion criteria: Women in the childbearing age whom has the Bacterial Vaginosis symptoms and has other inclusion criteria which is emphasized in the study; Interventions: Oral Metronidazole tablet 250mg, 2 tablets every 12 hours in both intervention and control groups will be administered. In the intervention group, vaginal cream of Jaft (one Applicator every night) is given. In the control group one Applicator of placebo cream every night is given. This study is a double-blinded placebo controlled clinical trial. The Vaginal creams (Jaft or Placebo), produced by school of pharmacy, are coded in A and B and researcher and the patients are both unaware about which cream ( placebo or Jaft) they are using; Main outcome: BV symptoms clinical and in the tests
General information
Acronym
BV Bacterial Vaginosis
IRCT registration information
IRCT registration number:IRCT2016071428929N1
Registration date:2016-09-07, 1395/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-07, 1395/06/17
Registrant information
Name
Atefeh Zare
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 901 535 4510
Email address
atp1990_zare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science budget
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral tablet of Metronidazole with vaginal cream of Jaft concurrent with oral tablet of Metronidazole on results of Bacterial Vaginosis (BV) management in childbearing age women
Public title
Comparison of the effect of oral tablet of Metronidazole with vaginal cream of Jaft concurrent with oral tablet of Metronidazole on results of Bacterial Vaginosis (BV) management in childbearing age women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to cooperate in the study; Married women of reproductive age (18 - 45); Symptoms of BV on clinical examination and confirmed by Amsel criteria (having three of four criteria) and confirmation by Gram stain and Nugent score should be 7-10; Lack of recent use of oral and topical medications such as Alkaloids, Anti-parasitic, Immunosuppressive drugs and other drugs during the past two weeks, according the patient report; No sexual intercourse during the past 24 hours; Lack of abnormal uterine bleeding (AUB); Lack of frequent bacterial infections which are resistant to treatment; Not to be pregnant and lactation; Lack of vaginal douche in the past 48 hours; Lack of specific diseases such as Liver disease, diseases of the Central Nervous System, Diabetes, Immune deficiency, according to patient report; Non-use of broad-spectrum Antibiotics, Anti-prostaglandins, Hormone therapy and Immunosuppressive, Anticoagulant and drug abuse in recent months; No history of hypersensitivity to Metronidazole; The patient should have only BV not other types of Vaginitis. Exclusion Criteria: Possible sensitivity to the drug (vaginal cream of Jaft), which is not seen so far; Lack of application of vaginal cream (Jaft or Placebo) and oral Metronidazole or discontinuing treatment; Taking any medication affecting the vaginal cream including Alkaloid drugs; Taking any medication affecting the symptoms of BV including broad-spectrum Antibiotic to treat other infections in the patient; Unwillingness of patients to continue or to cooperate; People who are considered sick on the patient's clinical symptoms but their test results does not endorse BV.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
168
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Street, Shiraz University of Medical Sciences Central building, Shiraz
City
Shiraz
Postal code
Approval date
2016-06-06, 1395/03/17
Ethics committee reference number
IR.SUMS.REC.1395.50
Health conditions studied
1
Description of health condition studied
Bacterial Vaginosis
ICD-10 code
N-99
ICD-10 code description
Diseases of the Genitourinary system
Primary outcomes
1
Description
Vaginal Discharge
Timepoint
Before and after the treatment of a week
Method of measurement
Through Smears of Vaginal discharges and Gram stained smears
Secondary outcomes
1
Description
To reduce infectious factors such as bacteria and clinical symptoms
Timepoint
After a week of treatment
Method of measurement
Through the smears of vaginal discharges and gram stained slides
Intervention groups
1
Description
The first intervention group, Oral tablet of Metronidazole 250 mg; 2 tablet; every 12 h, is given for 7 days.
Category
Treatment - Drugs
2
Description
The second intervention group vaginal cream of Jaft (one Applicator every night) is given coccurent with oral tablet of Metronidazole 250mg, 2 tablets every 12 h.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
GYN Clinic of Shahid Faghihi Hospital
Full name of responsible person
Bahieh Namavar Jahromi
Street address
First floor of Shahid Fghihi Hospital, Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Masum Masumpur
Street address
7th floor, Central building of Shiraz University of Medical Science , Next to the Red Crescen , Zand Street , Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
School of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Moshfeghy
Position
Masters of Midwifery
Other areas of specialty/work
Street address
Namazi squar, Shiraz
City
Shiraz
Postal code
Phone
+98 917 313 7561
Fax
Email
zmoshfeghy1385@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Zeinab Moshfeghi
Position
Masters of Midwifery
Other areas of specialty/work
Street address
Namazi Squar, Shiraz
City
Shiraz
Postal code
Phone
+98 917 313 7561
Fax
Email
zmoshfeghy1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Atefeh Zare
Position
Masters Student of Midwifery
Other areas of specialty/work
Street address
Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
atp1990_zare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)