Studying the effect of anti lophomonas parasite treatment on patients chronic cough well-being
Design
It is a Randomized, singles center, controlled clinical trial with a parallel group design and double blinded outcomes assessment. Randomization was done by Randomizer website ( www.randomizer.org).
Settings and conduct
This study will be done in asthma specialist clinic. After explaining the study for the patients, informed consent will be signed by them if they accept to enter the study.cough and its grading ,sputum and its color , dyspnea and its grading ,body temperature ,post nasal drip(PND),Lophomonas being and grading of inflammatory cell in sputum Smear and bronchoalveolarlavage(BAL) will be done and recorded before and after the treatment.these smears that will be colored by trichrome stain and will be studied by optical microscope.
Participants/Inclusion and exclusion criteria
patients suffering from more than one months cough who could not be controlled by past medical treatment,patients with normal physical examination , patients with normal chest x ray
Intervention groups
This study consists of Two groups of 30 patients. Patients in the first group takes Tinidazole 500 mg, and the second group take Placebo each 12 hours. Patients in each group will take the drugs for 2 weeks.
Main outcome variables
Tinidazole treatment
cough grading
sputum
color of sputum
Airway hyperresponsiveness (AHR)
Dyspnea
dyspnea grading
body temperature
post nasal drip (PND)
Lophomonas in sputum smear or Bronchoalveolar lavage (BAL)
Grading of Inflammatory cells in sputum smear or Bronchoalveolar lavage (BAL)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091111002695N10
Registration date:2020-12-07, 1399/09/17
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Majid Mirsadraee
Name of organization / entity
Islamic Azad University- Mashhad branch
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 6694
Email address
majidmirsadraee@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of anti lophomonas parasite treatment on patients chronic cough well-being
Public title
Effect of anti lophomonas parasite treatment on patients chronic cough well-being
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients suffering from more than one months cough who could not be controlled by past medical treatments
patients with normal physical examination
patients with normal chest-x-ray
Randomization was done by Randomizer website ( www.randomizer.org).
Blinding (investigator's opinion)
Double blinded
Blinding description
All the drugs will be prepared with united shape, color and packages. the only difference is the code on the package. The drugs will be given to our colleague who is present in the clinic everyday and is blinded to the types of the drugs and groups of treatment. Each time the patients refer to our clinic they will receive the same drug based on their randomized code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University- Mashhad branch
Street address
Shahin Far Building, sarab alley, Azadi street
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.IAU.MSHD.REC.1398.049
Health conditions studied
1
Description of health condition studied
chronic cough
ICD-10 code
R05
ICD-10 code description
Cough
2
Description of health condition studied
Lophomonas Blattarum
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lophomonas Blattarum being in smear or Bronchoalveolarlavage
Timepoint
Before intervention and 14 days after intervention
Method of measurement
Trichrome staining
2
Description
Chronic cough grading
Timepoint
Before intervention and 14 days after intervention
Method of measurement
Global Initiative for Asthma (GINA) guideline
Secondary outcomes
1
Description
dyspnea
Timepoint
Before intervention and 14days after intervention
Method of measurement
physical examination
2
Description
sputum inflammatory cells
Timepoint
Before intervention and 14days after intervention
Method of measurement
sputum cytology
3
Description
dyspnea garding
Timepoint
Before intervention and 14 days after intervention
Method of measurement
GINA(global strategy for asthma)
4
Description
Body temperature
Timepoint
Before intervention and 14days after intervention
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group:Tinidazole 500mg in form of tablet, one each 12 hours, for14 days. The Active Pharmaceutical Ingredient is provided by Pars daru Pharmaceutical company
Category
Treatment - Drugs
2
Description
Control group: Placebo in form of tablet B1 300 mg from Jalinus Pharmaceutical company ,one each 12 hours, for 14 days .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asthma specialist clinic
Full name of responsible person
Majid Mirsadraee
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esmail kheirkhah
Street address
Islamic Azad University of Mashhad, Ostad yousefi St., Emamiyeh Blv, Ghasemabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3663 7842
Email
research@mshdiau.ac.ir
Web page address
http://vcr.mshdiau.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Majid Mirsadraee
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Mirsadraee
Position
Full professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Mirsadraeeازا
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 80, 15th Kosar, Kosar Ave., Vakilabad Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3870 4347
Email
majidmirsadraee@mshdiau.ac.ir
Web page address
http://drmirsadraee.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
treat with Tinidazole( before and after treatment), cough garding( before and after treatment),sputum and its color ( before and after treatment), dyspnea and its grading( before and after treatment), temperature ( before and after treatment), Lophomonas existing in smear or BAL( before and after treatment), Inf cells grading in sputum and BAL( before and after treatment), Sex and age
When the data will become available and for how long
One Month after publishing the results.
To whom data/document is available
There will be no limitation for accessing the data.
Under which criteria data/document could be used
There will be no limitation for accessing the data. If someone need to use the data, he/she might ask the corresponding author for permission.
From where data/document is obtainable
Contact the corresponding author.
What processes are involved for a request to access data/document
After contacting the corresponding author via phone or Email, the data will be provided.