Determining the effect of hydroalcoholic extract of Nasturtium officinale on oxidative stress and inflammatory markers in asthma patients
Design
A randomized controlled clinical trail with parallel, double_blind, randomized, phase 2 group on 60 patients used the random allocation rule.
Settings and conduct
patients with asthma referred to Shahid Mofteh Hospital in Yasuj are are randomly divided into two groups by random allocation method. patients in the intervention group (30 patients) receive Nasturtium officinale extract capsules and in the control group (30 patients) receive placebo ( flour capsules) in the same form and amount. The treatment protocol in both groups in 500 mg capsules twice a day. Follow-up of patients is done every week during treatment and 8 weeks after the end of treatment. It should be noted that the patient and the researcher will not know about the assignment of groups and it is a double-blind study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adult male/female (age 18-65 years); asthma diagnosis based on the Global Initiative for Asthma (GINA); asthma symptoms not fully controlled based on ACT (Asthma Control Test) score from 5 to24; no severe asthma exacerbation in the last four weeks; Complete conscious satisfaction
Exclusion criteria: smoking history; pregnant women; taking any preparation containing NOE
Intervention groups
Intervention group: Capsules containing hydroalcoholic extract of Nasturtium officinale.
Control group: Capsules containing flour
Main outcome variables
reduced symptoms of asthma: wheezing, coughing, shortness of breath, chest tightness or pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201215049726N1
Registration date:2021-01-01, 1399/10/12
Registration timing:prospective
Last update:2021-01-01, 1399/10/12
Update count:0
Registration date
2021-01-01, 1399/10/12
Registrant information
Name
Nasrin Shakerinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3333 2892
Email address
nasrinsh299@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-16, 1399/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroalcoholic extract of Nasturtium officinale on oxidative stress and inflammatory markers in asthma patients
Public title
The effect of Nasturtium officinale extract on biomarkers in asthma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both sexes
age 18-65 years
asthma diagnosis based on the Global Initiative for Asthma (GINA)
asthma symptoms not fully controlled based on ACT (Asthma Control Test) score from 5 to24
no severe asthma exacerbation in the last four weeks
Complete conscious satisfaction
Exclusion criteria:
smoking history
pregnant women
taking any preparation containing NOE
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the Restricted randomization method of the randomization Random allocation rule method. For this purpose, first determine a total sample size, then randomly assign a set of them to the intervention group and the rest to the control group. 30 balls for the intervention group and 30 balls for the control group are placed in a lottery container and then the balls are randomly removed from the container without replacement and the created sequence is recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Capsules are individually packed envelopes and have an identification number. Capsules and envelopes of Nasturtium officinale extract and placebo are offered in exactly the same appearance and packaging, which will blind the participants and the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of the Yasuj University of Medical Sciences
Street address
No.55, Imamat 6, Revolution Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75918-38799
Approval date
2020-12-06, 1399/09/16
Ethics committee reference number
IR.YUMS.REC.1399.163
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
ACT score
Timepoint
0-28 days
Method of measurement
Asthma Control Test questionnaire
Secondary outcomes
1
Description
protein carbonyl
Timepoint
0-28
Method of measurement
Spectrophotometry
2
Description
Total thiol content
Timepoint
0-28 days
Method of measurement
Spectrophotometry
3
Description
protein sulfhydryl
Timepoint
0-28 days
Method of measurement
Spectrophotometry
4
Description
Malondialdehyde
Timepoint
0-28 days
Method of measurement
Spectrophotometry
5
Description
The ferric reducing antioxidant power
Timepoint
0-28 days
Method of measurement
Spectrophotometry
6
Description
Glutathione peroxidase enzyme
Timepoint
0-28 days
Method of measurement
Spectrophotometry
7
Description
Superoxide dismutase enzyme
Timepoint
0-28 days
Method of measurement
Spectrophotometry
8
Description
Catalase enzyme
Timepoint
0-28 days
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Nasturtium officinale extract (NOE) capsules 500 mg twice daily for 4 weeks used as a supplementary treatment.
Category
Treatment - Drugs
2
Description
Control group: capsule of 500 mg of flour are used twice a day for 4 weeks as a placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofattah Clinic, Yasuj
Full name of responsible person
Reza Abbasi
Street address
No.55, Imamat 6, Revolution Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75918-38799
Phone
+98 74 3334 6070
Fax
+98 74 3334 6071
Email
nasrinsh299@gmail .com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amirhossein Doustimotlagh
Street address
No.55, Imamat 6, Revolution Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
759138799
Phone
+98 74 3334 6070
Fax
+98 74 3334 6071
Email
amirhosseindoustimotlagh@ gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Amirhossein Doustimotlagh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
No.55, Imamat 6, Revolution Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75918-38799
Phone
+98 74 3334 6070
Fax
+98 74 3334 6071
Email
amirhosseindoustimotlagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amir Hossein Doustimotlagh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
No.55, Imamat 6, Revolution Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75918-38799
Phone
+98 74 3334 6070
Fax
+98 74 3334 6071
Email
amirhosseindoustimotlagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nasrin Shakernasab
Position
Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No.55, Imamat 6, Revolution Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75918-38799
Phone
+98 71 3333 2892
Email
nasrinsh299@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
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