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Comparison of the effect of Violet plant vaginal gel and metronidazole vaginal gel in treatment of bacterial vaginosis in women of reproductive age

Protocol summary

Study aim
Comparison of the effect of Violet plant vaginl gel and metronidazole vaginal gel in treatment of bacterial vaginosis in women of reproductive age
Design
Randomized control clinical Trial
Settings and conduct
The Formulation of the vaginal Viola gel prepared in Ahvaz Jundishapur laboratory of Pharmacy School. The metronidazole vaginal gel produced by Behvazan Pharmaceutical Company, Iran. It re-filled in tubes that were similar to vaginal Viola gel tubes. The participants will randomly allocated into two groups using permuted block method with block sizes of 4 and allocation ration of 1:1 after obtaining an informed written consent. Allocation sequence will identified using computerized random numbers by a person will not involve in recruitment, data collection and analysis. All participants got two 50-gram tubes of vaginal gels to use for 7 day. The primary outcomes will be success rate on Day 7 to 10 (the positive of one or none of Amsel’s criteria) and the recurrence rate (positive of at least two out of four Amsel criteria) on days 28 to 30 after starting treatment.
Participants/Inclusion and exclusion criteria
The inclusion criteria: Married non-pregnant and non-lactating women 15 -44 Years old, diagnosis of bacterial vaginosis based on at least 3 out of 4 Amsel criteria and gain score 4 to 6 with clue cells or score of 7 to 10 without the presence of clue cells from the Nugent scoring system and have willing to participate to study.
Intervention groups
the group receiving the violet plant vaginal gel
Main outcome variables
Vaginal discharge, Vaginal acidity, Whiff test, Clue cells

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200129046301N1
Registration date: 2020-09-14, 1399/06/24
Registration timing: registered_while_recruiting

Last update: 2020-09-14, 1399/06/24
Update count: 0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
Parisa Afsharniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8837 8893
Email address
afsharnia.p@ajums .ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-17, 1399/01/29
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Violet plant vaginal gel and metronidazole vaginal gel in treatment of bacterial vaginosis in women of reproductive age
Public title
Comparison of the Violet plant vaginal gel and metronidazole vaginal gel in treatment of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for entering the study: Married non-pregnant and non-lactating women 15 -44 Years old, diagnosis of bacterial vaginosis based on at least 3 out of 4 Amsel criteria and score 4 to 6 with clue cells or a score of 7 to 10 without the presence of clue cells frome the Nugent scoring system, willingness to participate to study, possibility to attending center in schedule time for post treatment follow up, Filling the Informed Consent Form.
Exclusion criteria:
Exclusion criteria: Vaginal bleeding, Frequently vulvovaginits, Candidiasis, Trichomonas vaginalis, Pregnancy, Mensturation, Breastfeeding, Frequent Use of vaginal douches, Consuming alcohol and coumarin anticoagulants and recent use of anti-parasit drugs, Anti-biotic drugs, Immunosuppressive drugs, Multiple sexual partner, Specific diseases such as liver, kidney diseases and central nervous system diseases, Blood dyscrasis, Diabetes, Weakening of the immune system, Sexually transmitted diseases, History of sensitive to the forme of temperament Rocky and topical, History sensitive to metronidazol tablet.
Age
From 15 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 88 women with BV will be randomly assigned to the Violet and metronidazole groups. Randomization with random quadruple blocks, block size 4, will be done using computer software. Metronidazole and Violet labels will be encrypted as A or B by someone unaware of the purpose of the study. The formulations of Violet and metronidazole will be similar in appearance and consistency. The person who will distributed among the subjects will not be aware of the purpose of study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, is blinding allocation in such a way that the drugs will be coded by the pharmacist ( A, B) and the pharmacist will need 50gr of each type of metronidazole gel 0.75% and 50gr violet gel 5%, will be poured separately into tube of one color and shape and the taboos will be coded at the pharmacists discretion, so that only the pharmacist knows which drug A belongs to and the code B belongs to which is the drug. The research units and researcher will not have any information about the nature of the drugs untile the end of the research and after analyzing the data.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Ahvaz jundishapour university of medical science
Street address
No. 234, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2020-01-17, 1398/10/27
Ethics committee reference number
IR.AJUMS.REC.1398.768

Health conditions studied

1

Description of health condition studied
Bacterial vaginosis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis

Primary outcomes

1

Description
Treatment of bacterial vaginosis
Timepoint
1 and 4 weeks after the intervention
Method of measurement
According to Amsel criteria: Examination of (vaginal discharge, color, acidity, presence of clue cells, Whiff test )

2

Description
Empty
Timepoint
Empty
Method of measurement
Empty

Secondary outcomes

1

Description
Vaginal discharge
Timepoint
Before starting the intervention, 1 and 4 weeks after the intervention
Method of measurement
Observation

2

Description
Vaginal acidity
Timepoint
Before starting the intervention, 1 and 4 weeks after the intervention
Method of measurement
Ph strip

3

Description
Whiff test
Timepoint
Before starting the intervention, 1 and 4 weeks after the intervention
Method of measurement
Koh 10%

4

Description
Clue cells
Timepoint
Before starting the intervention, 1 and 4 weeks after the intervention
Method of measurement
Evaluation of clue cells in the wet lam

Intervention groups

1

Description
Intervention group: Vaginal gel of violet plant oil 5%, 50 mgr, made by Ahwaz School of Pharmacy 5 mg every night applicator vaginally for 7 nights.
Category
Treatment - Drugs

2

Description
Control group: Metronidazole vaginal gel 0.75%, 50 mg, made by Behvazan Pharmaceutical Company 5 mg every night with applicator vaginally for 7 nights.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Parisa Afsharnia
Street address
Imam Khomeini Hospital, Azadegan Street, Ahvaz
City
Ahavaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
info@ajums.ac.ir
Web page address
https://himam.ajums.ac.ir/fa-IR/himam.ajums.ac/12815/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C-

2

Recruitment center
Name of recruitment center
Health and Medical center No. 10
Full name of responsible person
Parisa Afsharnia
Street address
Main Street 3, Phase 3, Mellat Ave, East of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6164873731
Phone
+98 61 3446 6438
Email
info@ajums.ac.ir

3

Recruitment center
Name of recruitment center
Sheiban Health and Medical center
Full name of responsible person
Parisa Afsharnia
Street address
Between 1st and 2nd streets, main boulevard, Sheiban
City
Ahvaz
Province
Khouzestan
Postal code
6164873731
Phone
+98 61 2327 3613
Email
info@ajums.ac.ir

4

Recruitment center
Name of recruitment center
Health and Medical center No. 3
Full name of responsible person
Parisa Afsharnia
Street address
Corner of Farahani, The first of Alavi alley, End of Kian, West of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6178663141
Phone
+98 61 3339 2293
Email
info@ajums.ac.ir

5

Recruitment center
Name of recruitment center
Health and Medical Center No. 4
Full name of responsible person
Parisa Afsharnia
Street address
Bazaarcheh street, Saadi alley, West of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6194893635
Phone
+98 61 3334 1021
Email
info@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Badvi
Street address
Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz
City
Ahavaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2114
Email
info@ajums.ac.ir
Web page address
https://ajums.ac.ir/fa-IR/portal/1/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C#
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parisa Afsharnia
Position
Student (MSs)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2114
Email
afsharnia.p @ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Ph.D of Reproductive Health (Midwifery)
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2114
Email
minairavani2004@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parisa Afsharnia
Position
Student (MSs)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2114
Email
afsharnia.p @ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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