Evaluation of therapeutic effect of oral N-Acetyl Cystein in comparison with placebo in patients diagnosed as subacute sinusitis, a double blind placebo controlled randomized clinical trial
The objective of this study was to investigate the therapeutic effect of oral N-Acetyl Cysteine (NAC) in the treatment of subacute sinusitis. 45 patients, aged 18 years old or more who had subacute sinusitis were enrolled in this randomized trial. All patients received Co-Amoxiclav (Amoxicillin 500 mg and Clavulanic acid 125mg Q8h, orally), pseudoephedrine (60mg three times a day, orally), and Sodium chloride irrigation for two weeks. In addition, patient received N-Acetyl Cysteine (6oo mg, three times a day, orally) in the intervention group but placebo in the control group during the treatment period (two weeks). Signs and symptoms of the disease, using Snat 20 questionnaire, paranasal sinus involvement, using PNS CT Scan and the results of nasal secretion cultures were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806112406N1
Registration date:2010-01-27, 1388/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-27, 1388/11/07
Registrant information
Name
Mehrzad Bahtouee
Name of organization / entity
Boushehr University of Medical Sciences, School of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 4044
Email address
mbahtouee@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research management center, Bushehr University of Medical Sciences
Expected recruitment start date
2008-11-19, 1387/08/29
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of oral N-Acetyl Cystein in comparison with placebo in patients diagnosed as subacute sinusitis, a double blind placebo controlled randomized clinical trial
Public title
Therapeutic effect of oral NAC on Sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of subacute sinusitis according to signs and symptoms 3 weeks to 3 months and signs of sinusitis in CT scan
Exclusion criteria: Presence of allergic rhinitis, asthma, pregnancy, diabetes mellitus, transplantation, CRF, chronic alcoholism, severe malnutrition, AIDS, Down syndrome, history of migraine, HTN, BPH, consumption of antidepressants, Methyl dopa, Propranolol, or Warfarin, history of kidney stone, or liver disease, more than 60 years old age, drivers, or pilots
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Research managment center, Bushehr University of Medical Sciences
Street address
Research managment center, Bushehr University of Medical Sciences, Moallem street, Bushehr
City
Bushehr
Postal code
Approval date
2010-06-10, 1389/03/20
Ethics committee reference number
1643/3/18/20/دپ
Health conditions studied
1
Description of health condition studied
subacute Sinusitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Culture of nasal secretion
Timepoint
1 month after competement of treatment
Method of measurement
microbiological culture
2
Description
Signs and symptoms of disease
Timepoint
1 day after completement of treatment
Method of measurement
face to face completement of Snot 20 questionnaire by a physician
3
Description
involvement of paranasal sinuses
Timepoint
1 month after competement of treatment
Method of measurement
CT scan, cure rate of sinusitis according to Lund-Mackay score
Secondary outcomes
1
Description
clinical improvement
Timepoint
1 day and one month after copletement of treatment
Method of measurement
snot20 questionaire
2
Description
Radiological improvement in paranasal CT scan
Timepoint
1 month after completment of treatment
Method of measurement
Lund-Mackey score
Intervention groups
1
Description
Co-Amoxiclav (Amoxicillin 500 mg and Clavulanic acid 125mg Q8h, orally), pseudoephedrine (60mg three times a day, orally), and Sodium chloride irrigation plus N-Acetyl Cysteine (6oo mg, three times a day, orally) for two weeks.
Category
Treatment - Drugs
2
Description
Co-Amoxiclav (Amoxicillin 500 mg and Clavulanic acid 125mg Q8h, orally), pseudoephedrine (60mg three times a day, orally), and Sodium chloride irrigation plus placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The outpatient clinic of Bushehr University of medical sciences
Full name of responsible person
Dr. Gholam_Hosein Monavvar_Sadegh
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research managment center of Bushehr University of Medical Sciences
Full name of responsible person
Dr. Keivan Zandi
Street address
Research managment center, Bushehr University of medical sciences, Moallem street, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research managment center 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
Dr. Gholam_Hosein Monavvar_Sadegh
Position
General physician
Other areas of specialty/work
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
dr.monavarsadegh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences, Medical Faculty
Full name of responsible person
Dr. Mehrzad Bahtouee
Position
Assistant Professor of Internal Medicine
Other areas of specialty/work
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
mbahtouee@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Faculty, Bushehr University of Medical Sciences
Full name of responsible person
Hesam_oddin Maneshi
Position
Medical Student
Other areas of specialty/work
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
h_maneshi@bpums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)