Improving of asthma symptoms by using curcumin along with standard asthma medications
Design
A total of 60 patients with bronchial asthma, referred to the Pulmonary Disease Research Center, were enrolled on the Inclusion and exclusion criteria , and then the patients were randomly assigned to two groups according to a random number table using the envelope.
At first, a checklist for demographic information, history of asthma, full history of the drug, and ... are completed for patients.
Settings and conduct
At first, a checklist for demographic information, a history of asthma, a full history of the drug, and ... for patients is completed. The ACT, AQLQ questionnaire is then used to control of asthma.
Spirometry is first performed. Then, 5 cc of brachial venous blood is taken in fasting state and the sample is sent to the liver count, liver, kidney tests.
The drug and placebo groups were randomly assigned and the first group received the standard treatment of asthma + curcumin 40 mg three times a day and the second group received standard asthma + placebo treatment three times a day.
The study was performed in a double blind clinical trial
Participants/Inclusion and exclusion criteria
Non-atopic asthmatic patients over 18 years of age without chronic underlying disease
Intervention groups
The first group received the standard treatment of asthma + curcumin 40 mg three times /day and the second group received standard asthma + placebo treatment three times / day.
Main outcome variables
FEV1,ACT,AQLQ
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161226031584N2
Registration date:2019-06-17, 1398/03/27
Registration timing:retrospective
Last update:2019-06-17, 1398/03/27
Update count:0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
Shahrzad Mohammadzadeh Lari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2742
Email address
larish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
2019-04-21, 1398/02/01
Scientific title
Investigation of effect of oral nanomicell curcumin on Improving of FEV1 and Quality of Life in Patients with Non-atopic Bronchial Asthma
Public title
Investigation of effect of Oral Nanomicelle Curcumin in Patients with Non-atopic Bronchial Asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
non atoic asthma
informed consent
Exclusion criteria:
smoker
COPD
pregnancy/lactation
heart ,liver,kidney disorder and gallbladder disease
acute exacerbation within one month ago
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, randomization method :( Random Concealmen)
Blinding (investigator's opinion)
Double blinded
Blinding description
A random allocation was made after explaining how to conduct the research and obtaining informed consent from patients. The type of treatment prescribed for each patient (in the form of Paired and odd numbers or code A, B) was written in tabs and each sheet was placed in an envelope. After the patient's visit, if the patient has inclusion critria, then he will remove the random concealment after explaining how the doctor will study. The checklist for demographic information and questionnaires used in the project is completed with the help of the researcher. The assigned number (Paired and odd numbers) is given to the patient (the blind doctor) and how they are used. The researcher records the delivered drug code (Paired and odd numbers). Due to the fact that the placebo is in every way similar to intervention, patients will not be aware of which group they are (patients are blind). After collecting the data, the analyzer analyzes the data according to their code (paired or individual).They (the evaluator and analyzer) will not be aware of the treatment.
Placebo
Used
Assignment
Parallel
Other design features
nanomicell curcumin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The code of ethics is "IR.MUMS.fm.REC.1395.259" and the date of approval is 03/04/1395.
Street address
Ahmadabad steet
City
Mashhad
Province
Razavi Khorasan
Postal code
The code of ethics i
Approval date
2016-06-23, 1395/04/03
Ethics committee reference number
The code of ethics is "IR.MUMS.fm.REC.1395.259" and the date of approval is 03/04/1395.
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J40-J47
ICD-10 code description
Chronic lower respiratory diseases
Primary outcomes
1
Description
FEV1,ACT ,AQLQ
Timepoint
Measuring the FEV1-ACT, AQLQ questionnaire every two weeks to two months.
Method of measurement
questionnaire ,spirometry,physical exam
Secondary outcomes
empty
Intervention groups
1
Description
Interventional group:Oral curcumin 40 mg three times a day (Sinacurcumin nanomicelle, Minoo Pharmacy Company, Tehran, Iran) as an Add-on therapy in Patients of Bronchial Asthma that the patient received in the past.
Category
Treatment - Drugs
2
Description
Control group: The placebo(which appears to be completely similar to the drug)was given three times daily as an Add-on therapy in Patients of Bronchial Asthma that the patient received in the past
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hosital
Full name of responsible person
Shahrzad mohamadzadeh lari
Street address
Pulmonary Diseases Research Center, Ghaem Hospital, Ahammad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 4083
Fax
+98 51 3859 4083
Email
ltrc@us.ac.ir
Web page address
http://ltrc.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research and Technology Deputy.
Street address
Pulmonary Disease Research Center, Ahmadabad Ave, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 4083
Email
ltrc@us.ac.ir
Web page address
http://ltrc.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pulmonary Diseases Research Center
Proportion provided by this source
100
Public or private sector
Private
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
Mashhad University of Medical Sciences
Full name of responsible person
Shahrzad Mohamadzadeh Lari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonologist
Street address
Pulmonary Disease Research Center, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 4083
Email
larish@mums.ac.ir
Web page address
http://ltrc.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahrzad Mohamadzadeh Lar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
pulmonologist
Street address
Ahmadabad Ave, Ghaem Hosital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 4083
Fax
+98 51 3859 4083
Email
larish@mums.ac.ir
Web page address
http://ltrc.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahrzad Mohamadzadeh Lari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
pulmonologist
Street address
Ahmadabad Ave, Ghaem Hosital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 4083
Email
larish@mums.ac.ir
Web page address
http://ltrc.mums.ac.ir/
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