Evaluation of gene expression, methylation and secretory level of cytokines and inflammatory chemokines in COPD patients receiving nanocurcumin supplementation compared with patients receiving placebo
Evaluation of gene expression, methylation and secretory level of cytokines and inflammatory chemokines in COPD patients receiving nanocurcumin supplementation compared with patients receiving placebo
Design
30 patients with COPD receiving 80 mg of nanocurcumin daily for 90 days and 30 patients receiving placebo before and after the intervention will receive 10 cc of blood containing anticoagulant to isolate PBMC.
Settings and conduct
This project will be carried out in Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Diagnosed with COPD with stage B, C, or D according to GOLD 2019.
Age between 40-75 years old.
Both genders.
Smoker or less than 6 months of smoking cessation time.
Exclusion Criteria:
Asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer).
Acute and/or active infection.
Cancer.
Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
Liver and kidney failure.
Pregnancy.
Patients with life expectancy less than 6 months due to concomitant illness.
Under immunosuppressive treatment within 8 weeks of the first screening visit.
Intervention groups
30 patients with COPD receiving 80 mg of nanocurcumin daily for 90 days and 30 patients receiving placebo before and after the intervention will receive 10 cc of blood containing anticoagulant to isolate PBMC.
Main outcome variables
gene expression, methylation and secretion levels of cytokines IL-1, IL-6, IL-18, IFN-γ and TNF-α and Chemokines CXCL8 and CCL2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200324046851N2
Registration date:2022-02-22, 1400/12/03
Registration timing:prospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Majid Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
ahmadi.m@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-06-04, 1401/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of gene expression, methylation and secretory level of cytokines and inflammatory chemokines in COPD patients receiving nanocurcumin supplementation compared with patients receiving placebo
Public title
Evaluation of gene expression, methylation and secretory level of cytokines and inflammatory chemokines in COPD patients receiving nanocurcumin supplementation compared with patients receiving placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with COPD with stage B, C, or D according to GOLD 2019..
Age between 40-75 years old.
Both genders.
Smoker or less than 6 months of smoking cessation time
Exclusion criteria:
Asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer).
Acute and/or active infection.
Cancer.
Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
Liver and kidney failure.
Pregnancy.
Patients with life expectancy less than 6 months due to concomitant illness.
Under immunosuppressive treatment within 8 weeks of the first screening visit
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and the lead researcher were unaware of medication or placebo in different patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Academic Committee on Research Ethics (Studies in Human Subjects) tabriz University of Medical Scien
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.TBZMED.REC.1400.767
Health conditions studied
1
Description of health condition studied
Chronic Obstructive Pulmonary Disease (COPD)
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
IL-1
Timepoint
Day 0 and day 90 after receiving the drug
Method of measurement
ELISA and PCR
2
Description
CCL2
Timepoint
Day 0 and day 90 after receiving the drug
Method of measurement
ELISA and PCR
3
Description
CXCL8
Timepoint
Day 0 and day 90 after receiving the drug
Method of measurement
ELISA and PCR
4
Description
IL-6
Timepoint
Day 0 and day 90 after receiving the drug
Method of measurement
ELISA and PCR
5
Description
IL-18
Timepoint
Day 0 and day 90 after receiving the drug
Method of measurement
ELISA and PCR
6
Description
IFN-γ
Timepoint
Day 0 and day 90 after receiving the drug
Method of measurement
ELISA and PCR
7
Description
TNF-α
Timepoint
Day 0 and day 90 after receiving the drug
Method of measurement
ELISA and PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nanocurcumin recipient.From 30 patients with COPD receiving 80 mg of nanocurcumin daily for 90 days before and after the intervention, 10 cc of blood containing anticoagulant will be taken to isolate PBMC
Category
Treatment - Drugs
2
Description
Control group: Placebo receiving group. From 30 patients with COPD receiving pelacebo daily for 90 days before and after the intervention, 10 cc of blood containing anticoagulant will be taken to isolate PBMC
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Ali Hazrati
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ziba Mujtahid
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 5921
Email
hrmnet@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Hazrati
Position
Student
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Marzdaran
City
Tabriz
Province
East Azarbaijan
Postal code
5158963161
Phone
+98 41 3638 7391
Email
alihazrati833@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Hazrati
Position
Student
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5158963161
Phone
+98 41 3638 7391
Email
alihazrati833@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Hazrati
Position
Student
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5158963161
Phone
+98 41 3638 7391
Email
alihazrati833@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