The purpose of this study was to evaluate the effect of Chlorella vulgaris therapy in improving symptoms and lung function tests in patients with silicosis. Silicosis patients with severe or chronic signs and complicated forms of silicosis, have been included. Those patients with having heart disease, Forced Expiratory Volume and Therapeutic Lifestyle Changes less than 40 percent, Non-cooperation during Pulmonary Function Tests and Tuberculosis infection were excluded from this study. 47 patients were randomly allocated into two groups,24 intervention group and 23 standard group including Bronchodilator. In the intervention group, along with other available chemical drugs, was prescribed nine tablets of Algomed, at start of study and after 8 weeks. clinical symptoms, general appearance, and spirometry indices were measured and compared before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010720592N1
Registration date:2015-04-20, 1394/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-20, 1394/01/31
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
not Funding
Expected recruitment start date
2011-01-30, 1389/11/10
Expected recruitment end date
2012-01-30, 1390/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Chlorella Vulgaris complementary therapy in improving symptoms and pulmonary function test measures
in patients with silicosis
Public title
Effects of Chlorella Vulgaris in improving of symptoms of silicosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signs and symptoms of severe, chronic and complicated forms of silicosis;
Age between 18 to 75.
Exclusion criteria:
Having heart disease;
Forced Expiratory Volume and Therapeutic Lifestyle Changes less than 40 percent;
Non-cooperation during Pulmonary Function Tests;
Ptients with the history of hospitalization due to the disease exacerbations during the past three months;
Tuberculosis infection;
Body Mass Index more than 30
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shahid Beheshti University of Medical Sciences
Street address
Yemen Street, Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Under review
Health conditions studied
1
Description of health condition studied
silicosis
ICD-10 code
J62.8
ICD-10 code description
Pneumoconiosis due to other dust containing silica
Primary outcomes
1
Description
Number of attacks
Timepoint
at the start of the study and after 2 months
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group , In addition to standard therapy, 9 Algomed tablets daily for eight weeks
Category
Treatment - Drugs
2
Description
Control Group: Standarad treatment (Bronchodilator)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares hospital
Full name of responsible person
Seyed Mohammad reza hashemian
Street address
18 km road Najaf Abad, Najaf Abad, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Sadoughi
Street address
Shahid Beheshti University of Medical Sciences, Tabnak Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Masih daneshvari hospital
Full name of responsible person
Seyed Mohammad reza Hashemian
Position
Associate Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
0098
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Seyed Mohammad reza hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
seyed mohammad reza hashemian
Position
Associate Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2610 9512
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)