Determining the effect of hydro alcoholic extract of Nasturtium officinal on the quality of life in patients with asthma
Design
A randomized controlled clinical trail with parallel, double_blind, randomized, phase 2 group on 50 patients used the random allocation rule.
Settings and conduct
patients with asthma referred to Shahid Mofteh Hospital in Yasuj are randomly divided into two groups by random allocation method. patients in the intervention group (25 patients) receive Nasturtium officinale extract capsules and in the control group (25 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
Mean quality of life score (by each dimension) of patients, mean score of sleep quality of patients with asthma, mean score of asthma control test (ACT) of patients, mean blood eosinophils of patients with asthma and mean serum IgE of patients with asthma before and After intervention in the placebo group and the group receiving hydroalcoholic extract of watercress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220506054749N1
Registration date:2022-06-08, 1401/03/18
Registration timing:registered_while_recruiting
Last update:2022-06-08, 1401/03/18
Update count:0
Registration date
2022-06-08, 1401/03/18
Registrant information
Name
Ezat Zareie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3730 2150
Email address
zaree.e@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-07-23, 1401/05/01
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 quality of life in asthmatic patients
Public title
The effect of hydroalcoholic extract of Nasturtium officinale on quality of life in asthmatic 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
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
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
Ethics Committee of Yasouj University of Medical Sciences
Street address
Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2020-11-24, 1399/09/04
Ethics committee reference number
IR.YUMS.REC.1399.157
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthema Control Test score
Timepoint
Before intervention - 28 days after intervention
Method of measurement
ACT test questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention - 28 days after intervention
Method of measurement
Quality of Life Questionnaire (SF-12)
2
Description
Quality of sleep
Timepoint
Before intervention - 28 days after intervention
Method of measurement
Petersburg Sleep Quality Questionnaire (PSQI)
3
Description
Number of eosinophils
Timepoint
Before intervention - 28 days after intervention
Method of measurement
Cismax device
4
Description
Immunoglobulin E
Timepoint
Before intervention - 28 days after intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group:Watercress was collected from Shahniz (Margon) region of Kohgiluyeh and Boyer-Ahmad provinces in the summer of 1399. After collecting watercress, 100 grams of plant powder is soaked in 500 ml of ethanol and placed at room temperature for 48 hours. The extract is then filtered and the rest is extracted again with solvent after 24 hours and added to the original extract. The solvent is then evaporated at a temperature of 40 ° C by a rotary refrigerator and incubated at a temperature of 37 ° C to dry extract and stored in the refrigerator at a temperature of 4 ° C for further experiments. To the group of hydroalcoholic extract of watercress in the amount of 500 mg twice a day for 4 weeks. Blood samples and all questionnaires (including ACT test, quality of life and sleep disorders) are completed at the beginning and end of the study by research units. Blood samples are taken from the Clot and CBC tubes. To measure the number of blood eosinophils, a CBC test is performed with a Cismax device. The serum sample is also elucidated and stored at minus -70 ° C. IgE levels are then measured.
Category
Treatment - Drugs
2
Description
Control group: Flour and capsules were prepared and placed in 500 mg capsules in jars of the same shape and size as the main medicine and packaged (of course in the university without my presence) and the patient was explained in person that twice a day. Consume for 28 days.
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
Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 917 343 0030
Fax
+98 74 3334 6071
Email
amirhosseindoustimotlagh@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
Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 937 531 7741
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
Dr Reza Abbasi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
:33346070-074
Email
amirhosseindoustimotlagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Abbasi Reza
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6070
Email
amirhosseindoustimotlagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Zarei Ezat
Position
PHD Candidate
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Motahari Bolivar
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 71 3730 2350
Fax
+98 74 3334 6071
Email
EZZT.ZAREI1294@gmai.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