The evaluation of the aqueous extract of Malva Sylvesteris, in the treatment of mild to severe adult asthmatic patients in comparison with placebo group; randomized double-blind study
The aim of this study is to use the aqueous extract of Malva Sylvestris in the treatment of the adult patients with mild to severe asthma in comparison with a control (placebo) group. This randomized double blind study (neither the patients, nor the researchers will be aware of the treatment and placebo assigned groups) will be conducted over the 100 patients with asthma. Inclusion criteria: age between 15-65 years, minimum 6 months with mild to severe asthma, non-seasonal asthma and non-smoker. Exclusion criteria: respiratory infection, immunologic and neurological disorders, pregnancy, history of myocardial infarction, chronic obstructive pulmonary disorder and diabetes. Using block randomization method, patients will be randomly assigned into two groups (group 1: 600 mg/day aqueous extract of Malva Sylvestris and group 2: placebo) and will be under the treatment for 1 month. The severity and changes in the asthma symptoms will be measured by questionnaire and pulmonary function tests, before, 1 and 3 months after initiation of the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082318899N1
Registration date:2014-11-30, 1393/09/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-30, 1393/09/09
Registrant information
Name
Mojtaba Keshavarz
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1253 4044
Email address
mo.keshavarz@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research of Bushehr University of Medical Sciences
Expected recruitment start date
2014-10-07, 1393/07/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the aqueous extract of Malva Sylvesteris, in the treatment of mild to severe adult asthmatic patients in comparison with placebo group; randomized double-blind study
Public title
The effects of Mallow in the treatment of asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 15-65 years, minimum 6 months with mild to severe asthma, non-seasonal asthma and non-smoker
Exclusion criteria: respiratory infection, immunologic and neurological disorders, pregnancy, history of myocardial infarction, chronic obstructive pulmonary disorder and diabetes
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Mosala street
City
Bushehr
Postal code
Approval date
2014-06-16, 1393/03/26
Ethics committee reference number
B-93-16-5
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
chronic obstructive asthma
Primary outcomes
1
Description
Forced expiratory volume at first second (FEV1)
Timepoint
Before, 1 month and 3 months after treatment
Method of measurement
Pulmonary function test by spirometry
Secondary outcomes
1
Description
Adverse effects of Malva Sylvestris extract
Timepoint
1 and 3 months after treatment
Method of measurement
Questionnaire and pulmonary function test using spirometry
Intervention groups
1
Description
Intervention 2 in control group: placebo including capsules contain sucrose twice a day for 1 month by oral route
Category
Treatment - Drugs
2
Description
Intervention 1: aqueous extract of Malva Sylvestris at doses of 600 mg/day (300 mg twice a day by oral route for 1 month)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr Khalij Fars hospital
Full name of responsible person
Mehrzad Bahtoee
Street address
Mosala Street
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for research of Bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostovar
Street address
Bahmani
City
Busehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for research of Bushehr 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
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Mojtaba Keshavarz
Position
PhD/ faculty
Other areas of specialty/work
Street address
Mosala street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
moj.ph60@yahoo.commkeshavar80@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Mojtaba Keshavarz
Position
PhD/ faculty
Other areas of specialty/work
Street address
Mosala street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
moj.ph60@yahoo.commkeshavar80@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Mojtaba Keshavarz
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)