Protocol summary

Study aim
Determining the effect of oral syrup containing Pistacia atlantica oleoresin in improving subacute and chronic cough symptoms
Design
The study is conducted as a randomized clinical trial with a control group, with two parallel groups and in a three-way blind (patient, doctor, data analyst) and patients are randomly divided into groups. Twenty-four non-smoking outpatients with chronic cough (duration of cough between 8 and 100 months) of any origin referred to Shahid Rahimi Hospital clinic from the beginning of 2014 to 2014.
Settings and conduct
Permuted block randomization so that first all 4 blocks containing two codes A and B are prepared (6 blocks) then random blocks are selected by placement using a table of random numbers. These blocks form a sample-sized sequence of A and B codes, each of which is randomly assigned to one of the groups. The list of relevant codes will remain confidential until the end of the project. The place of study is the doctor's office in Khorramabad.
Participants/Inclusion and exclusion criteria
Entry criteria: subacute (3 to 8 weeks) and chronic (more than 8 weeks) cough, age over 18 years Exclusion criteria: use of other antitussive drugs, opioids, sedatives, antihistamines, antibiotics, bronchodilators, history of asthma, history of chronic bronchitis, pneumonia, lung abscess or pulmonary tuberculosis, smokers.
Intervention groups
Groups receiving three doses of syrup containing Pistacia atlantica oleoresin
Main outcome variables
The number of cough attacks per day and the number of coughs per attack Checking the quality of cough. In each examination, the level of recovery is evaluated as complete recovery (complete cessation of cough), partial recovery (the patient expresses satisfaction with the reduction of cough or the duration of cough is halved), no recovery (the medicine does not cause any change in the severity of cough).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100420003760N9
Registration date: 2024-11-02, 1403/08/12
Registration timing: retrospective

Last update: 2024-11-02, 1403/08/12
Update count: 0
Registration date
2024-11-02, 1403/08/12
Registrant information
Name
Marzieh Rashidipour
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 667 4776
Email address
m.rashidipour@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and evaluation of oral Syrup containing aqueous extract of Rosa canina L fruit and oleoresin essential oil of Pistacia Atlantica in improving the cough due to acute bronchitis
Public title
Cough syrup
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from subacute (3 to 8 weeks) cough Suffering from chronic (more than 8 weeks) cough
Exclusion criteria:
Taking other antitussive drugs Use of opioids Taking sedatives Taking antihistamines Taking antibiotic drugs Use of bronchodilators History of asthma History of chronic bronchitis Getting pneumonia Pulmonary abscess or pulmonary tuberculosis smokers
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients into four groups and also using stratified random allocation. In this way, classes are made based on age group (below 30 years and greater than or equal to 30 years), cough severity (chronic cough, sub acute), body mass index status (less than 25 and greater than or equal to 25) are constructed (12 classes in total).. Within each class, random permutation blocks are used to assign samples to the required groups. To create random sequences, letters A, B , C or D(corresponding to the experimental group) will be used as follows. ABCD: 0-3 ABDC: 4-7 ACBD: 8-11 ACDB:12-15 . . DABC DBAC DCAB DCBA: 92-95 Then a corner of the table of random numbers is selected and two-digit numbers are read from top to bottom, and finally, according to the read number, a random sequence of letters A to D is registered in the desired floor. Finally, a random sequence of letters A to D (corresponding to the 4 experimental groups) will be created in each class of all existing classes, and the samples will be assigned to 4 groups based on this random sequence.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be triple blind, which means that the pain intensity assessor, the patient and the data analyst are not aware of the type of treatment assigned to the patient. In addition, the decipherer is not a member of the research team and the edible syrups in all groups are completely identical in appearance. Data registration in the statistical software and data analysis is done by the statistical consultant without mentioning the names of the groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Lorestan University of Medical Sciences
Street address
No 20, Anooshirvan Rezaei Square, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6816889468
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.LUMS.REC.1402.197

Health conditions studied

1

Description of health condition studied
cough
ICD-10 code
R05
ICD-10 code description
Cough

Primary outcomes

1

Description
Number of coughing attacks per day
Timepoint
Fourth and seventh day
Method of measurement
Interview/questionnaire

2

Description
Number of coughs per attack
Timepoint
Fourth and seventh day
Method of measurement
Number of coughs per attack

3

Description
Checking the quality of cough. In each examination, the level of recovery is complete recovery (complete cessation of cough), partial recovery (the patient expresses satisfaction with the reduction of cough or the duration of cough is halved), no recovery (the medicine does not cause any change in the severity of cough).
Timepoint
Fourth and seventh day
Method of measurement
Number of coughs per attack

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: group receiving a low dose of syrup containing Pistacia atlantica oleoresin
Category
Treatment - Drugs

2

Description
Intervention group 2: the group receiving a medium dose of syrup containing Pistacia atlantica oleoresin
Category
Treatment - Drugs

3

Description
Intervention group 3: the group receiving a high dose of syrup containing Pistacia atlantica oleoresin
Category
Treatment - Drugs

4

Description
Control group: group receiving syrup made without Pistacia atlantica oleoresin
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Lung specialist doctor's office
Full name of responsible person
Marzieh Rashidipour
Street address
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3312 0172
Fax
+98 66 3312 0172
Email
m_rashidi80@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
ِDr.Bahram Rasoulian
Street address
No. 20, Anooshirvan Rezaei Square, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0172
Fax
+98 66 3312 0172
Email
bahramrasoulian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Marzieh Rashidipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3312 0172
Email
m_rashidi80@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Marzieh Rashidipour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3312 0172
Email
m_rashidi80@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Marzieh Rashidipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golshan 2 Ave. Enghelab Blvd.
City
Khorramabad
Province
Lorestan
Postal code
6816889468
Phone
+98 66 3312 0172
Email
m_rashidi80@yahoo.com

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
Only part of the data, such as information about the main consequence or similar, can be shared
When the data will become available and for how long
Start the access period 18 months after printing the results.
To whom data/document is available
Data will only be available to researchers working at academic and scientific institutions
Under which criteria data/document could be used
The data will only be used to inform the results of the study
From where data/document is obtainable
Lorestan University of Medical Sciences
What processes are involved for a request to access data/document
Refer to Lorestan University of Medical Sciences, Vice Chancellor of Research and Technology, Research Projects Department, Management of Research Projects Department, 066333120175, Mrs. Sajedi , fax:066333120173 call mrs. zarei 0989167083314
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