Determine the Clinical Effects of Chlorhexidine Vaginal Gel in the Treatment of Vaginal Infections,This Study is Double-Blind Clinical Trial That Randomly Drug is Delivered to Patients.The First Step is aking the formulation. The new Drug formulation, Chlorhexidine Vaginal Gel in Pharmaceutics Laboratory in Aseptic Conditions and Then Packaging and labeling is taken. Second the Step the Patients will Examine then are Placed in three Groups: Vaginal Candidiasis, Bacterial Vaginosis, Unspecific Vaginitis.In the first Group with Vaginal Clotrimazole (1a) or a Vaginal Gel Chlorhexidine (1 b),
The second Group of Metronidazole Vaginal Cream (2 a) or Chlorhexidine Vaginal Gel (2 b),
Third Group clotrimazole Vaginal with Metronidazole (3a) or Chlorhexidine Vaginal Gel (3 b) prescribed.Vaginal Ointment at Bedtime an Applicator to five Days and Metronidazole 500 mg every 12 hours to five days.
To better Evaluate the Therapeutic effects and Potential Drug side effects in addition to the completion of Drug use (after five days), two and three weeks after Treatment to Evaluate the visit.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016070428780N1
Registration date:2017-02-08, 1395/11/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-08, 1395/11/20
Registrant information
Name
Maryam Zangene
Name of organization / entity
Kermanshah University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 832 3419
Email address
ma_zangeneh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-06-25, 1395/04/05
Expected recruitment end date
2017-03-25, 1396/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Effects of Chlorhexidine Vaginal Gel in the Treatment of Vaginal Infections
Public title
Treatment of Vaginal Infections
Purpose
Treatment
Inclusion/Exclusion criteria
List Inclusion and Exclusion criteria separately(Inclusion Criteria: Women Before the age of Menopause and Non-pregnant; with Abnormal Vaginal Discharge; Without Underlying Disease Such as Diabetes; Immunosuppressive Drugs; Cervicitis and Excluded criteria: There are no Specific Criteria)
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah, Ave shahid beheshti. Building No. 2
City
Kermanshah
Postal code
-
Approval date
2016-06-25, 1395/04/05
Ethics committee reference number
Kums.rct.1395.218
Health conditions studied
1
Description of health condition studied
Vaginal Infection
ICD-10 code
N74*
ICD-10 code description
Female pelvic inflammatory disorders in diseases classified elsewhere
Primary outcomes
1
Description
Vaginitis
Timepoint
A week after Intervention
Method of measurement
Physical Examination and the Patient's Scoring
Secondary outcomes
1
Description
Vaginal Irritation
Timepoint
Within a Week
Method of measurement
Question
2
Description
Nausa
Timepoint
Within a Week
Method of measurement
Question
3
Description
Vomiting
Timepoint
Within a Week
Method of measurement
Question
Intervention groups
1
Description
The Third Group Included Patients with Concurrency both Vaginitis. For 5 days, one day in between , Clotrimazole Vaginal with Metronidazole or Chlorhexidine Vaginal Gel is Prescribed. In order to better Evaluate the Therapeutic Effects and Potential Drug side Effects, two and three weeks after Treatment, one day Patients refer to Hospital for Visited again.
Category
Treatment - Drugs
2
Description
The Second Group Included Patients are Bacterial Vaginosis. For 5 days, one day in Between , Metronidazole Vaginal Cream or Chlorhexidine Vaginal Gel is Prescribed. In order to better evaluate the therapeutic effects and Potential Drug side Effects, two and three weeks after Treatment, one day Patients refer to Hospital for Visited again.
Category
Treatment - Drugs
3
Description
The First Group Included Patients with Vaginal Candidiasis. For 5 days, one day in between , Clotrimazole Vaginal Cream or Vaginal Gel Chlorhexidine is prescribed. In order to better evaluate the Therapeutic effects and Potential drug side Effects, two and three weeks after Treatment, one day patients refer to Hospital for Visited again.