Evaluation of the effect of oral phytosome prepared from wild Pistacia atlantica oleoresin on symptomatic and spirometric improvement of patients with moderate to severe asthma compared with standard treatment: a randomized clinical trial
Evaluation of the effect of oral phytosome prepared from wild Pistacia atlantica oleoresin on symptomatic and spirometric improvement of patients with moderate to severe asthma compared with standard treatment
Design
A randomized clinical trial, triple blind, 104 patients enrolled and followed for four weeks
Settings and conduct
Patients diagnosed with moderate or severe asthm are randomly divided into groups receiving three doses of tablets (or oral capsules) and a placebo group.The patients are evaluated for 4 weeks and spirometry is recorded at the end of 4 weeks. The patients will be evaluated at asthma and allergy specialist office.
Participants/Inclusion and exclusion criteria
Inclusion: Patients aged 15 years and older who referred to the asthma and allergy specialist's office with a diagnosis of moderate or severe allergic asthma. Exclusion: Having other respiratory diseases except asthma; Pregnant and lactating women; People with a history of drug allergy;Taking anti-leukotriene drugs; People who use supplements or other inhalation and non-inhalation drugs; Having special diseases
Intervention groups
1: Receiving placebo in addition to common treatment; 2: receiving the first dose of phytosome formulation containing wild pistachio oleoresin in addition to common treatment; 3: receiving the second dose of phytosome formulation containing wild pistachio oleoresin in addition to the common treatment; 4: receiving the third dose of phytosome formulation containing wild pistachio oleoresin in addition to common treatment
Main outcome variables
Times of waking up with an asthma attack during the past week; Severity of symptoms during the past week;The amount of restrictions in daily activities during the past week;The severity of breath during the past week; wheezing during the past week;The average number of daily puffs of short-acting inhaled bronchodilators used during the past week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100420003760N5
Registration date:2022-11-08, 1401/08/17
Registration timing:registered_while_recruiting
Last update:2022-11-08, 1401/08/17
Update count:0
Registration date
2022-11-08, 1401/08/17
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
2022-10-30, 1401/08/08
Expected recruitment end date
2023-10-30, 1402/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral phytosome prepared from wild Pistacia atlantica oleoresin on symptomatic and spirometric improvement of patients with moderate to severe asthma compared with standard treatment: a randomized clinical trial
Public title
Phytosome prepared from wild Pistacia Atlantica oleoresin on symptomatic and spirometric improvement of patients with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 15 years and older referring to the asthma and allergy specialist's office with a diagnosis of moderate or severe allergic asthma
Exclusion criteria:
Having other respiratory diseases except asthma
Pregnant and lactating women or with a desire to become pregnant
People with a history of drug allergy
Taking anti-leukotriene drugs
People who use supplements or other inhalation and non-inhalation drugs beyond what is allowed in this study.
Having other special diseases such as kidney disease, tumor, etc.
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
104
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 40 years and older or equal to 40 years), gender (male and female) and severity (moderate or severe). Within each class, random permutation blocks (8 blocks) are used to assign samples to the required groups. To create random sequences, letters A, B or C (corresponding to the experimental group) will be used as follows.
A B C: 0-16
ACB : 17-32
B A C: 33-48
B C A: 49-64
C A B: 65-80
C B A: 81-96
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is triple-blinded, the therapist (recorder of spirometry parameters and questioner of the clinical evaluation form), the patient and the data analyst are uninformed and the decoder is not a member of the research team.
Placebo
Used
Assignment
Other
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
2021-05-18, 1400/02/28
Ethics committee reference number
IR.LUMS.REC.1400.050
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
The times of waking up with an asthma attack during the past week (zero to six according to the questionnaire); The severity of symptoms during the past week (zero to six according to the questionnaire); The amount of restriction in daily activities during the past week (zero to six according to the questionnaire); the severity of breath during the past week (zero to six according to the questionnaire); wheezing during the past week (zero to six according to the questionnaire).The daily puffs of short-acting inhaled bronchodilators used during the past week (zero to six according to the questionnaire)
Timepoint
Before, and after intervention. Spirometry time 0 and 30
Method of measurement
Through Asthma Control Questionnaire and spirometry.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive the first dose(50) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment
Category
Treatment - Drugs
2
Description
Intervention group: receive the second dose(100) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment
Category
Treatment - Drugs
3
Description
Intervention group: receive the third dose(200) of phytosome formulation containing wild pistachio oleoresin in addition to conventional treatment
Category
Treatment - Drugs
4
Description
Control group: receive placebo in addition to conventional treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asthma and allergy specialist 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
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 0173
Email
m_rashidi80@yahoo.com
Web page address
http://research.lums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Environmental toxicology; Herbal medicine
Street address
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
City
khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3320 4005
Email
m_rashidi80@yahoo.com
Web page address
http://lums.ac.ir/
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
Environmental toxicology; Herbal medicine
Street address
No. 140, Razi Ave. Pajohandeh Blvd, Herbal Research Center
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 916 667 4776
Fax
+98 66 1331 4005
Email
m.rashidipour@lums.ac.ir
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
Environmental toxicology; Herbal medicine
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 0173
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