The purpose of this study is to assess the efficacy of Licorice lozenges comparing with placebo for treatment of chronic cough. 60 patients with confirmed chronic cough with non-response criteria selected. In this double blind pilot study, the patients and researchers will be blinded about receiving Drug and Placebo allocation. Patients will be randomized into group A (Licorice lozenges daily, for 2 weeks) and group B (placebo lozenges daily, for 2 weeks). At the end of therapy (2 weeks) and at baseline (first), 2 weeks after receiving drug and placebo cough severity, will be evaluated and compared between groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015022421220N1
Registration date:2015-11-22, 1394/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-22, 1394/09/01
Registrant information
Name
Hajar Ghaemi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4127
Email address
haghaemi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Double-blind Clinical Trial: The effect of Licorice lozenges vs. placebo on chronic cough treatment
Public title
The effect of Licorice lozenges on chronic cough treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients between 18-70 years old; with resistant idiopathic chronic cough for more than 8 weeks; written informed consent to participate in the project
Exclusion criteria: any allergic reaction to the drug; asthma; COPD; GERD; Rhinitis; pregnancy and lactation; hypertension; arrhythmia; Zollinger syndrome; mineralocorticoid and anticoagulants consumers; pregnancy during the study; the drug lost more than three doses; increasing in blood pressure during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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, Shiraz University of Medical Sciences
Street address
Zand street, Shiraz University of Medical Sciences, 7th floor
City
Shiraz
Postal code
Approval date
2013-04-27, 1392/02/07
Ethics committee reference number
CT-92-6507
Health conditions studied
1
Description of health condition studied
Chronic Cough
ICD-10 code
R05
ICD-10 code description
Cough-chronic
Primary outcomes
1
Description
Cough severity
Timepoint
Baseline
Method of measurement
Leicester cough questionnaire
Secondary outcomes
1
Description
Cough severity
Timepoint
2 weeks after treatment and 2 weeks after the end of intervention
Method of measurement
Leicester Cough Questionnaire
Intervention groups
1
Description
Intervention Group: Licorice lozenges/day for 2 weeks. Patients will be followed at Baseline, 2 weeks and one month after starting intervention.
Category
Treatment - Drugs
2
Description
Placebo Group: Placebo lozenges/day for 2 weeks. Patients will be followed at Baseline, 2 weeks and one month after starting intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhary Clinic
Full name of responsible person
Dr. Hajar Ghaemi
Street address
Motahhary Clinic, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Masoom Masoompour
Street address
Motahhary Clinic, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hajar Ghaemi
Position
Pharm.D, PhDc Student in Traditional Pharmacy
Other areas of specialty/work
Street address
Motahhary Clinic, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3647 4376
Fax
Email
haghaemi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Masoom Masoompour
Position
Subspecialty of Pulmonary Disease and Faculty Member of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Motahhary Clinic, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 3647 4376
Fax
Email
masoomm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hajar Ghaemi
Position
Pharm.D, PhDc Student in Traditional Pharmacy
Other areas of specialty/work
Street address
Motahhary Clinic, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran.
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)