This study aimed to determine the effect of Portulaca oleracea seeds on indicators of inflammation, 8 - Isoprostane and lung function in women with asthma. In this study, women with age 18 years who having moderate asthma for at least 1 year as diagnosed by a physician according the Gina guideline include and Poeple with lung disorders and respiratory tract infections, kidney, liver or cardiovascular diseases, any change in medication type and dosage, having a history of oxalate stones and having a exacerbation in last month that led to hospitalization will be exclude then 70 patients randomly divided into two groups. In the intervention group,patients have treatment protocol and daily take 10 g Portulaca oleracea seeds in two doses (5 gm) in morning (fasting) and before dinner with a glass of water.In control group, Patients have their treatment protocol and drink two glasses of water in a day for 8 weeks. 8 - Isoprostane, inflammatory factors including IL-4, TNF_α and nitric oxide metabolites (nitrite and nitrate) will be measure in sputum samples that collected at first and end of study. In order to determine the pulmonary function tests, FEV1 and PEF are measured by the spirometer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206094105N7
Registration date:2012-07-05, 1391/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-06-25, 1391/04/05
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Portulaca oleracea seeds on indicators of inflammation,8-isoprostane and lung function in women with asthma : a randomized controlled trial
Public title
Effect of Portulaca oleracea seeds on indicators of inflammation,8-isoprostane and lung function in women with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: • female • Age 18 years and above •having Moderate asthma for at least 1 year as diagnosed by a physician according the Gina guideline
Exclusion criteria: • Smoking • having other lung disorders and respiratory tract infections • Pregnant or lactating • kidney, liver or cardiovascular disease • taking any multivitamin and mineral and dietary supplements containing antioxidants and omega-3 in 2 months ago • Any change in drug type and dosage • having a history of oxalate stones • having a exacerbation in last month that led to hospitalization • follow a diet • taking contraceptive pills
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad Ave
City
Tabriz
Postal code
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
9145
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
moderate asthms
Primary outcomes
1
Description
IL-4, TNF_α and nitric oxide metabolites (nitrite and nitrate)
Timepoint
before and after of intervention
Method of measurement
sputum sample
2
Description
8 - Isoprostane
Timepoint
before and after of intervention
Method of measurement
sputum sample
3
Description
PEF and FEV1
Timepoint
before and after of intervention
Method of measurement
spirometer
Secondary outcomes
1
Description
Food intake
Timepoint
Before and after of intervention
Method of measurement
24-hour dietary recall
2
Description
BMI
Timepoint
Before and after of intervention
Method of measurement
Scales and meters
Intervention groups
1
Description
In the interventional group,patients have treatment protocol and daily take 10 g Portulaca oleracea seeds in two doses (5 gm) in morning (fasting) and before dinner with a glass of water .
Category
Treatment - Drugs
2
Description
In control group, Patients have their treatment protocol and drink two glasses of water in a day for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic
Full name of responsible person
Dr, khalil ansarin
Street address
Corner of Ostadan alley, Golgasht street, Azadi street,
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Golbad Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Beit Allah Alipour
Position
Assistant Professor
Other areas of specialty/work
Street address
Attar Neyshabouri Street, Golgasht Street
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 7580
Fax
Email
balipoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Hosseini
Position
MSc student in community nutrition
Other areas of specialty/work
Street address
Attar Neyshabouri Street, Golgasht
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 7580
Fax
Email
z_hosseini64@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)