Evaluating the impact of saturated steam with salt in improving pulmonary tests results and status of patients with Chronic Obstructive Pulmonary Disease attend in Dr. Masih Daneshvary hospital of Tehran in 1395 to 1396
Since few studies have been evaluated the impact of Halotherapy on COPD symptoms, the aim of current study is evaluating the impact of Halotherapy on improving pulmonary tests results and status of patients with Chronic Obstructive Pulmonary Disease referred to Dr. Masih Daneshvary hospital of Tehran.
Methods: In this double blind clinical trial, 85 patients with COPD who are in stable condition are randomly divided into two groups after recording their information on disease. Study is starting in autumn 2016. After two months treatment with Saltair by salt natural crystals or placebo, patients were re-examined and entered to a phase of clearance. Then patients attended in hospital for next visit by physician and after recording data, groups were crossed-over and treated for next two months of drug and placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080927995N2
Registration date:2016-11-26, 1395/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Alireza Eslaminejad
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2002
Email address
eslaminejadalireza@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences, National Research Instutute of Tuberculosis and Lung Diseases (NRITLD)
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the impact of saturated steam with salt in improving pulmonary tests results and status of patients with Chronic Obstructive Pulmonary Disease attend in Dr. Masih Daneshvary hospital of Tehran in 1395 to 1396
Public title
Evaluating the impact of Halotherapy on improving pulmonary tests results and status of patients with Chronic Obstructive Pulmonary Disease referred to Dr. Masih Daneshvary hospital of Tehran in 2016 to 2017
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: COPD patients regarding GOLD criteria; Stable patients older 18 years . Exclusion criteria: History of surgery in thorax; COPD exacerbation; Unbearable complications of COPD; Huge changes in treatment regimen; Missing patients through out the study; Irregular treatment; Smoking; Exacerbation in comorbidities like CHF, CRF, etc.
Age
From 18 years old to 99 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yanan, Velenjak, Tehran
City
Tehran
Postal code
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
Sbmu1.REC.1390.22
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive: airway disease NOS lung disease NOS
Primary outcomes
1
Description
The walked distance
Timepoint
two month after first visit
Method of measurement
6MWT
2
Description
forced vital capacity
Timepoint
two month after study beginning
Method of measurement
spirometry
3
Description
forced expiratory volume
Timepoint
two month after study beginning
Method of measurement
spirometry
4
Description
Minute
Timepoint
2 month after first visit
Method of measurement
6MWD
Secondary outcomes
1
Description
Disease manifestation
Timepoint
2 month after first visit
Method of measurement
Asking patients
2
Description
Exacerbation rate
Timepoint
Every other month
Method of measurement
Asking patients
Intervention groups
1
Description
A kind of inhalation therapy with a mineral salt as an alternative treatment named halotherapy twice a day each for 30 minutes for 2-months
Category
Treatment - Drugs
2
Description
Patients in control group use plastic contained Saltairs which have no inhaler in it actually as placebo drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital NRITLD
Full name of responsible person
Alireza Eslaminejad
Street address
Masih Daneshvari Hospital, Daarabad, Niavaran, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Eslaminejad
Street address
Masih Daneshvari Hospital, Daarabad, Niavaran, 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Eslaminejad
Position
Assistant Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Daarabad, Niavaran, Tehran, Iran
City
Tehran
Postal code
1956944413
Phone
+98 21 2610 9647
Fax
Email
eslaminejadalireza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Chronic Respiratory Diseases Research Center, NRITLD
Full name of responsible person
Alireza Eslaminejad
Position
Assistant Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Daarabad, Niavaran, Tehran, Iran
City
Tehran
Postal code
1956944413
Phone
+98 21 2610 9647
Fax
+98 982126109647
Email
eslaminejadalireza@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
CRDRC-NRITLD
Full name of responsible person
Alireza Eslaminejad MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Daarabad, Niavaran, Tehran, Iran
City
Tehran
Postal code
1956944413
Phone
+98 21 2610 9647
Fax
+98 21 2610 9647
Email
eslaminejadalireza@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)