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A comparison study of the therapeutic effect of "honey plus coffee" and inhaled Fluticason/Salmetrol on the chronic bronchiolitis in the chemical injured patients following exposure to sulfur mustard

Protocol summary

Summary
The aim of this study is to investigate the efficacy of different interventions and to compare their effects on improving the respiratory function in the patients with sulfur mustard gas (SM) induced chronic bronchitis or bronchiolitis. About 75 chemical injured patients (CIPs) symptomatic with: cough, dyspnea and night awakening will be randomly and double blindly assigned to three study groups. For every participant a special solution (syrup) is produced, which every 1000 cc of it contains: 500 grams of honey and 70 grams coffee, for the first group (the proper amount for every one week's use), but for the other two groups, it is made of liquid glucose (as uniformity). These participants are told to drink 50 cc of the prescribed solution every 8 hours (for 12 weeks). In addition inhalant sprays are prescribed for them to use three times a day (for 12 weeks). The inhalant spray contains "Normal Saline" (as uniformity) for the first group, "Fluticason 500 micrograms daily / Salmetrol 100 micrograms daily" for the second group, and "Salbutamol 800 micrograms daily / Beclomethasone 1000 micrograms daily " for the third group. Study main outcomes are assessment the cough, dyspnea and night awakening, air trapping in HRCT, increased residual volume in PFT or Spirometry. All the participants will be evaluated before the treatment and at the end of the 2nd, 4th, 8th and 12th weeks. The results will be compared between the study groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104294737N4
Registration date: 2011-05-09, 1390/02/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-05-09, 1390/02/19
Registrant information
Name
Mohammad Ali Raeessi
Name of organization / entity
Baqiyatallah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 0514
Email address
raeessi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr. Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study of the therapeutic effect of "honey plus coffee" and inhaled Fluticason/Salmetrol on the chronic bronchiolitis in the chemical injured patients following exposure to sulfur mustard
Public title
A comparison study of the therapeutic effect of "honey plus coffee" and inhaled Fluticason/Salmetrol on the chronic bronchiolitis in the chemical injured patients following exposure to sulfur mustard
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Chemical injured patients (CIPs) symptomatic with: cough, dyspnea, night awakening. Having significant air trapping in High resolution computed tomography (HRCT) and a marked increase of residual volume in pulmonary function tests (PFT). Exclusion criteria: Other potential causes of chronic cough and lung disease including cigarette smoking.
Age
From 21 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
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

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee in Medical Sciences Research, Deputy of Research and Technology, Baqiyatallah Univer
Street address
Sheikhbahaee St., Mollasadra Ave
City
Tehran
Postal code
14359
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
2684

Health conditions studied

1

Description of health condition studied
Chronic bronchiolitis
ICD-10 code
J44.8
ICD-10 code description
Other specified chronic obstructive pulmonary disease

Primary outcomes

1

Description
Cough
Timepoint
On admission and at the end of week 2,4, 8 and12 of the treatment
Method of measurement
Measurement of severity of cough: normal (0), low (+), moderate (++), and severe (+++)

Secondary outcomes

1

Description
Dyspenea
Timepoint
On admission and at the end of week 2,4, 8 and 12 of the treatment
Method of measurement
Measurement of severity: normal (0), low (+), moderate (++), and severe (+++)

Intervention groups

1

Description
First intervention group:Spray of Normal saline + A syrup like solution of 500 gr Honey with 70 gr coffee for every one week. (Duration of intervention is 12 weeks)
Category
Treatment - Drugs

2

Description
Second intervention group:Spray of Fluticason 500 microgr / Salmetrol 100 microgr / daily + A syrup like solution of liquid Glucose. (Duration of intervention is 12 weeks)
Category
Treatment - Drugs

3

Description
Third intervention group: Spray of Salbutamol inhaler 800 microgr daily+ Spray of Beclomethason 1000 microgr daily + A syrup like solution of liquid Glucose. (Duration of intervention is 12 weeks)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah UniversityHospital of Medical Sciences ( and the Hospital)
Full name of responsible person
Dr. Mohammad Ali Raeessi
Street address
Mollasadra Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dr. Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Street address
No117, Molasadra residental complex, Kharazmi st., Mollasadra Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Mohammad Ali Raeessi + Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Position
Assistant professor
Other areas of specialty/work
Street address
No.117, Mollasadra residental complex, Kharazmi St, Mollasadra Ave.
City
Tehran
Postal code
1435913118
Phone
+98 21 8803 0514
Fax
Email
raeessi_ma@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Position
Assistant professor
Other areas of specialty/work
Street address
No: 117, Molasadra residental complex, Kharazmi st., Mollasadra Ave.
City
Tehran
Postal code
1435913118
Phone
+98 21 8803 0514
Fax
Email
raeessi_ma@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah Universityof Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Raeessi
Position
Assistant Prof.
Other areas of specialty/work
Street address
No117, Molasadra residental complex, Kharazmi st., Mollasadra Ave.
City
Tehran
Postal code
1435913118
Phone
+98 21 8803 0514
Fax
Email
raeessi_ma@yahoo.com
Web page address
raeessi_ma@yahoo.com; raeessi@bmsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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