Evaluation of “Zofa” herbal syrup in hospitalized patients with post infection cough
Design
A Double Blind Randomized Clinical Trial with 100 patients
Settings and conduct
Hospitalized patients who meet criteria will be chosen. All demographic data will be collected. patients will be in two different group randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hospitalized patient with consent form/ age 18 to 75 year/ cough after infection diagnosed by physician. Exclusion criteria: participating in another study/ pulmonary disease/ hemoptysis/ rhinitis and allergy/ DM 1&2/ seizure/ receiving venlafaxin,phenytoin, phenobarbital, gentamicin/ GERD/ smoking/ hypersensitivity to herbal medicine/ pregnancy and lactation/ use of ACEI which may cause cough
Intervention groups
Intervention group: receiving 10cc Zofa syrup TDS for 1 week
Control group: receiving 10cc placebo syrup TDS for 1 week
Main outcome variables
relieving cough
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210508051215N1
Registration date:2021-05-18, 1400/02/28
Registration timing:registered_while_recruiting
Last update:2021-05-18, 1400/02/28
Update count:0
Registration date
2021-05-18, 1400/02/28
Registrant information
Name
Marziyeh Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2321
Email address
heydarimarziyeh89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-02, 1400/02/12
Expected recruitment end date
2021-07-03, 1400/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of “Zofa” herbal syrup in hospitalized patients with post infection cough: A Double Blind Randomized Clinical Trial
Public title
Evaluation of "Zofa" herbal syrup in cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All hospitalized patient with post-infection cough
Exclusion criteria:
Participating in another study
Known case of DM 1 & 2, seizure, pulmonary disease like asthma and COPD
Drug history of phenytoin, phenobarbital, gentamicin and venlafaxin
Symptoms like hemoptysis which may have special diagnosis
Pregnancy and lactation
Drug which may cause cough like ACEI
History of Rhinitis and allergy, GERD, smoking
Hypersensitivity to any ingredient of herbal syrup
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be in two group which include 50 person by use of randomized list provided by randomization scheme of permuted blocks way.
Blinding (investigator's opinion)
Double blinded
Blinding description
All syrups are coded. All participants, nurses, physician, investigator, analyzor are blinded and did not know which one is drug or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Qods St
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.TUMS.TIPS.REC.1400.026
Health conditions studied
1
Description of health condition studied
post infection cough
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
cough score in visual analogue scale
Timepoint
Day 1,2,7,14
Method of measurement
visual analogue scale
2
Description
cough score in simplified cough score
Timepoint
Day 1,2,7,14
Method of measurement
Simplified cough score
3
Description
Score in cough symptom score
Timepoint
Day 1,2,7,14
Method of measurement
Cough symptom score
Secondary outcomes
1
Description
Data laboratory changes
Timepoint
Daily
Method of measurement
Data laboratory from blood sample
Intervention groups
1
Description
Intervention group: the coded syrup will be administrated each 8h 10 cc for 1 week
Category
Treatment - Drugs
2
Description
Control group: the coded syrup will be administrated each 8h 10 cc for 1 week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeinin hospital
Full name of responsible person
Marziyeh Heydari
Street address
Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
14197 33141
Phone
+98 21 6119 0000
Email
heydarimarziyeh89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojgan Karbakhsh Davari
Street address
Qods St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8889 6696
Email
mkarbakhsh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Marziyeh Heydari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 218, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417763388
Phone
+98 21 6119 2321
Fax
Email
heydarimarziyeh89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marziyeh Heydari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 218, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417763388
Phone
+98 21 6119 2321
Fax
Email
heydarimarziyeh89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marziyeh Heydari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 218, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417763388
Phone
+98 21 6119 2321
Email
heydarimarziyeh89@gmail.com
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