Comparison of the effectiveness of traditional medicine product and metronidazole vaginal gel in the treatment and prevention of recurrence in patients with bacterial vaginosis
Comparison of the effectiveness of traditional medicine product and metronidazole vaginal gel in the treatment and prevention of recurrence in patients with bacterial vaginosis
Design
The two-group clinical trial, with a control group, with parallel groups, triple blind, randomized, phase 2 with 60 patients. Randomization.com is used for randomization.
Settings and conduct
In this study, 60 women aged 18-50 years referred to gynecological clinics affiliated to Mashhad University of Medical Sciences, which were approved according to the criteria of bacterial vaginosis
The study is three-blind. Capsules and tubes of the same shape are placed in the same number in similarly numbered envelopes and therefore participants, researchers, data analysts are unaware of the intervention and control groups. Only the sample allocator to the groups is aware of the control and intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married non-pregnant and non-lactating women; 15 -44 Years old; Positive at least 3 out of 4 Amsel criteria.
Non-inclusion criteria: Use of antibiotics in the last 4 weeks; Known chronic diseases; Taking coumarin anticoagulants; Diarrhea
Intervention groups
Intervention group:10% rhubarb Vaginal Gel and Oral Capsule containing 200 mg of rhubarb Extract for a week.
Control group: Metronidazole 0.75 mg Vaginal gel and placebo capsule for a week
Comparison of the effectiveness of traditional medicine product and metronidazole vaginal gel in the treatment and prevention of recurrence in patients with bacterial vaginosis
Public title
Effect of Persian medicine product on the recovery and relapse of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women
18 -50 years old
Positive at least 3 out of 4 Amsel criteria
Exclusion criteria:
Pregnancy
Lactation
Menopause
Vaginal bleeding
Use of antibiotics in the last 4 weeks
Known chronic diseases
Using oral contraceptives to prevent pregnancy
Smoking and Consuming alcohol
Using Coumarin anticoagulants
Multiple sexual partners
Diarrhea
Age
From 18 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We prepare 60 envelopes and numbers from one to 60. We prepare and print random numbers with the help of the Randomaize.com site and put them inside the envelopes. Capsules and tubes with the same shape and same number are put in the same envelopes based on a random allocation list by a person outside the research project. We ask patients to choose an envelope containing a number and to receive the relevant medicine envelope according to the number
Blinding (investigator's opinion)
Triple blinded
Blinding description
The capsules and tubes in the same shape and number are placed in numbered envelopes and therefore participants, researchers and data analysts are unaware of the intervention and control groups. Only the sample allocator to the groups is aware of the control and intervention group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University Of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.MUMS.REC.1399.429
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
Acute vagi
ICD-10 code description
N76.0
Primary outcomes
1
Description
Cure (Elimination of all Amsel criteria or remaining only one criterion and according to the agent scoring system, a score of 1 to 3 or 4 to 6 without key cells)
Timepoint
10 days after the start of treatment and 30 days after the end of treatment
Method of measurement
Amsel and Najnat criteria
Secondary outcomes
1
Description
Vaginal discharge
Timepoint
10 days after the start of treatment and 30 days after the end of treatment
Method of measurement
observation
2
Description
Vaginal acidity
Timepoint
10 days after the start of treatment and 30 days after the end of treatment
Method of measurement
Ph strip
3
Description
Whiff test
Timepoint
10 days after the start of treatment and 30 days after the end of treatment
Method of measurement
Koh 10% solution
4
Description
Clue cells
Timepoint
10 days after the start of treatment and 30 days after the end of treatment
Method of measurement
Evaluation of clue cells in the wet lam
5
Description
Nagnet score
Timepoint
10 days after the start of treatment and 30 days after the end of treatment
Method of measurement
Evaluation of stained slide
Intervention groups
1
Description
Intervention group: 10% vaginal gel prepared from aqueous extract of rhubarb root and oral capsule containing 200 mg of aqueous extract of rhubarb root will be used for a week to treat bacterial vaginosis.
Category
Treatment - Drugs
2
Description
Control group: Vaginal gel 0.75% metronidazole and placebo capsules will be used by the samples for a week to treat bacterial vaginosis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Malihe Afiat
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2609
Email
afiatm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences, Qureshi Building, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Moosaei
Position
PhD candidate in Iranian Traditional and Complementary Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
Mousaeis941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Motavasselian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, East Door, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Email
MotavasselianM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedighe Mousaei
Position
Persian Traditional Medicine Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, East Door, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Fax
Email
mousaeis941@mums.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