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Assessment effect of suppository of a drug based on Percian medicine on bacterial vaginosis

Protocol summary

Summary
This study is a randomized double-blind clinical trial. The goal of this study is a comparison of vaginal suppositories a drug based on Persian medicine (from Myrtus commuis, Foeniculum vulgare, Tamarindus indica & Tribulus terrestris) with Metronidazole vaginal suppository for treatment of bacterial vaginosis. In this study, 120 women 18-50 years refer to the Women's Hospital in Tehran (Moheb yas Hospital) with symptom of infection in genital tract that Amsel criteria for bacterial vaginosis are positive in them; after Consent, Medical history and Notification will be completed. These persons will be evaluated from uterine discharge medicine, the itching, color and odor of discharge, dilution and concentration Discharge, dyspareunia, dysuria will be checked by the PhD student. If a person suffers from other diseases, she will be excluded. Then, All patients were randomly divided into two groups, one group of people will be received based pharmaceutical products of traditional medicine and other group will be received metronidazole vaginal suppository For 7 days. It should be noted that the physician and the patient does not notice any information on the content of drugs. Two groups randomly receive coded medical kits (without drug name tag) in the form of suppositories . The next visit, a few days after the check out medication; again, tests will be done and a specialist physician will visit patients. Finally, with the help of statistical analysis evaluated the effectiveness of products compared with metronidazole vaginal Suppository.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062528613N1
Registration date: 2016-10-22, 1395/08/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-22, 1395/08/01
Registrant information
Name
Nasrin Baery
Name of organization / entity
School of traditional medicine Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
baeerin891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences, Iranian Traditional Medicine college, Numbering Plan 25511-86-03-93
Expected recruitment start date
2016-06-07, 1395/03/18
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment effect of suppository of a drug based on Percian medicine on bacterial vaginosis
Public title
Assessment effect of suppository of a drug based on Percian medicine on bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Outpatient women aged 18- 50 years with symptoms such as burning and itching refer and amsel criteria for bacterial vaginosis is positive for them; that Both treatments (chemical or herbal) do not use;They do not suffer from organic diseases such as cancer or other malignancies of the uterus or ovaries or Patients with chronic diseases. Exclusion criteria: Patients who use other antibiotics during the study; Patients who are experiencing possible side effect; Patients who have other medical interventions needed;This group of patients who have a severe form of the disease and other therapies and may require hospitalization have been included; Patients who request personal decision to withdraw from the study; Patients with immunosuppressive disorders; people with HIV; Patients with other infections such as genital herpes or trichomoniasis or fungal or gonorrhea at the same time with bacterial vaginosis; People who take other medication Such as the use of immunosuppressive drug or consumers of anti-inflammatory;consumers of showers vaginal and vaginal acidifying agents
Age
From 15 years old to 50 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 120
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
The ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Qods St, Keshavarz Blvd Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Approval date
2016-06-07, 1395/03/18
Ethics committee reference number
IR.TUMS.REC.1395.2662

Health conditions studied

1

Description of health condition studied
bacterial vaginosis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitisinitis

Primary outcomes

1

Description
Amsel criteria
Timepoint
Before the intervention,10-14 days after begining of treatment
Method of measurement
Amsel have 4 criteria: key cells in the wet mount vaginal sample Vaginal dyscharge thin and white uniform - gray, white or yellowish, Vaginal pH equal to or greater than 4/5, positive whiff test. If at least 3 of the 4 cases mentioned above is positive, bacterial vaginosis is brought on .

2

Description
Clinical signs for example Malodorous discharge, Itching, dyspareunia, having bad smell during sexual intercourse
Timepoint
Before the intervention, 10-14 day after intervention
Method of measurement
Measured by asking from patient

Secondary outcomes

1

Description
Side effects
Timepoint
Within 10 to 14 days of intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Consumption of vaginal Suppository from medicinal products of iranian traditional medicine based on Tribulus terrestris
Category
Treatment - Drugs

2

Description
Vaginal metronidazole suppository 500 mg for 7 nights
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Moheb Yas Hospital
Full name of responsible person
Nasrin Baery
Street address
Vali Asr Square, on the corner of Sarv & North Nejatolahi Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Gholamreza Amin
Street address
School of Pharmacy Tehran University of Medical Science
City
Tehran
Grant name
طرح شماره 25511-86-03-93
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
Faculty of Traditional Medicine
Full name of responsible person
Nasrin Baery
Position
Physician, PHD student
Other areas of specialty/work
Street address
Bahar St. Jahad St. front of Mehran stadium
City
Mashhad
Postal code
Phone
+98 51 3855 2189
Fax
+98 51 3853 5980
Email
n.baery76@yahoo.com baeerin891@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Pharmacy Tehran University of Medical Science
Full name of responsible person
Dr Gholamreza Amin
Position
Pharmacognosy
Other areas of specialty/work
Street address
School of Pharmacy Tehran University of Medical Science
City
Tehran
Postal code
Phone
+98 21 6412 2311
Fax
Email
gh_amin@yahoo.com, amin@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Traditional Medicine
Full name of responsible person
Nasrin Baery
Position
PhD student of Traditional Medicin
Other areas of specialty/work
Street address
Bahar St. Jahad St. front of Mehran stadium
City
Mashhad
Postal code
Phone
+98 51 1855 2189
Fax
Email
n.baery76@yahoo.com baeerin891@mums.ac.ir
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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