Comparing the therapeutic effect of oral metronidazole alone and oral metronidazole in combination with Prangos ferulacea vaginal cream on bacterial vaginosis cure.
The aim of this study is to compare the effect of Therapeutic Prangos vaginal cream in combination with oral metronidazole and oral metronidazole alone in bacterial vaginosis cure. This study is a double- blind, placebo-controlled randomized clinical trial. Totally, 110 married 15-49 old women; non pregnant; non breast-feeding who complain about gray malodor discharge are treated free of charge in clinics affiliated to Khoramabad University of Medical Sciences. Diagnosis is made by three out of four Amsel criteria and Nugent criteria. Patients are devided randomly in two fifty-five person groups. We put the letter “A” or “B” on that match with the code of each regimen (The researcher know nothing about the contents of these two boxes. Then the patients take a card out of box randomly and will be given medical treatment based on the letters on the cards. Both groups will be put under treatment with oral metronidazole (Two-250 mg tablets two times a day for seven days should be taken). In addition, patients’ in the intervention group are given Prangos vaginal cream and the control group are given placebo vaginal cream for seven nights. Patients who don't use the medicine at least for two days; having intercourse with partner and having no tolerance to any forms of medicine will be excluded of this research. Seven days after completing the treatment, the Amsel and Nugent critetia and side effects of medicine will be recorded. The main outcome measure is bacterial vaginosis infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042327534N1
Registration date:2016-10-29, 1395/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-29, 1395/08/08
Registrant information
Name
Asieh Azadpourmotlagh
Name of organization / entity
(International Branch), Faculty of Nursing & Midwifery, Shahid Beheshti University of Medical Scienc
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 9020
Email address
azadpurmotlagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences.
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic effect of oral metronidazole alone and oral metronidazole in combination with Prangos ferulacea vaginal cream on bacterial vaginosis cure.
Public title
The effect of Prangos ferulacea vaginal cream on the treatment of bacterial vaginosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 15-49 year old married women; non pregnant; Not breast feeding; Non menopaused; Non smoker; Willing to participate in the research; Complaine of malodor gray discharge; Not having vaginal infections; Not having unusual vaginal bleeding during the treatment; Not intercoursing during the treatment; Not using vaginal ointment, suppository or douching from two days before during the treatment; Not having chronic diseases like heart or kidney problemes, diabetes, arthoritis,...; Not having any transplant; Not using broad-spectrum antibiotics, hormones, anticoagulant and immunosuppressive medicine; Not having STD disease and not being allergic to metronidazole or topical medications.
Exclusion criteria: Unwilling to continue participating in the reseach; Not using vaginal ointment for two consecutive days; Being allergic to metronidazole or Prangos ferulacea vaginal cream or intolerance to any forms of medicine; having intercourse during in the treatment; Having vaginal infections (trichomonas and candidiasis with bacterial vaginosis); become pregnant during treatment; incomplete questionnaire.
Age
From 15 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
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 Shahid Beheshti University of Medical Sciences.
Street address
No. 19, next to the Hemat bridge, Shaheed Abbaspour avenue (Tavanir), Vali Asr street.
City
Tehran
Postal code
7413934358
Approval date
2016-01-17, 1394/10/27
Ethics committee reference number
IR.SBMU.IASB.REC
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis infection.
ICD-10 code
N77
ICD-10 code description
Vulvovaginal ulceration and inflammation in diseases classified elsewhere
Primary outcomes
1
Description
Studing the secretion of vaginal regarding to its color, odour and the existence of cluecells with Amsel criteria
Timepoint
Before interference and 7 days after treatment
Method of measurement
Amsel test includes 4 criteria. The existence of at least 3 criteria out of 4 to diagnose bacterial vaginosis is essential. Criteria includes homogen secretion, thin and white looks more like gray, the existence of cluecell in microscope, increasing pH vaginal to more than 4.5 and positive wiff test.
2
Description
Studing vaginal secretion with Nugent scoring.
Timepoint
Before treatment and 7 days after treatment.
Method of measurement
Nugent scoring is used to evaluate colored smear. If in vaginal disgharges, undera microscope(whit magnify 100X) the clue cell, gram negative cocobacili or mobilonococs is observed, bacterial vaginosis is diagnosed(Nugent score is more than 4).
Secondary outcomes
1
Description
Bacterial Vaginosis infection.
Timepoint
Before the intervention, seven days after start treatment.
Method of measurement
Clinical symptoms questionnaire is completed by patients ( Itching, burning, abnormal discharge, malodor discharge).
Intervention groups
1
Description
Intervention group: metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days in combination with Prangos vaginal cream for 7 nights
Category
Treatment - Drugs
2
Description
Control group: metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our plasebo vaginal cream.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers affiliated to Lorestan University of Medical Sciences( Khorramabad city).
Full name of responsible person
Master of Midwifery student, Asieh Azadpourmotlagh
Street address
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences.
Full name of responsible person
Dr. Mahrokh Dolatian.
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, School of Nursing and Midwifery, Shahid Beheshti 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
(International Branch),Shahid Beheshti University of Medical Sciences.
Full name of responsible person
Asieh Azadpourmotlagh
Position
Master of Midwifery student.
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.