To study the effect of Pregabalin for the treatment of subacute and chronic refractory cough
Design
Randomized controlled trial, with two arm parallel group of 30 patients, will be enrolled between May 2019 and December 2019, and will follow for 2 weeks.
Settings and conduct
In this research, 30 eligible patients whit subacute or chronic refractory cough referring to Shahid Beheshti Hospital of Qom were chosen. Then, patients by block randomization were randomly divided into two control and intervention groups. The intervention group will receive pregabalin capsule and control group will receive placebo capsule. Participants and outcome assessor does not know the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: subacute cough (between 3 and 8 weeks) or chronic cough. Exclusion criteria: history of asthma, history of chronic bronchitis pneumonia, pulmonary abscess or pulmonary tuberculosis, smokers
Intervention groups
Intervention group: pregabalin capsule, oral, 150 mg, every 12 hours for two weeks. Control group: placebo capsule, oral, every 12 hours for two weeks
Main outcome variables
Number of cough attacks per day and number of coughs per attack
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170215032587N5
Registration date:2019-03-12, 1397/12/21
Registration timing:prospective
Last update:2019-03-12, 1397/12/21
Update count:0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Mohammad Aghaali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 751 5639
Email address
maghaali@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pregabalin for the treatment of subacute and chronic refractory cough
Public title
Pregabalin for the treatment of cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subacute cough (between 3 and 8 weeks) or chronic cough
Exclusion criteria:
History of asthma
History of chronic bronchitis
Pneumonia, pulmonary abscess or pulmonary tuberculosis
Smokers
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be assigned to two groups of intervention and control by block randomization. For this purpose blocks of size 4 will be used. Six blocks will include BAAB, ABBA, BABA, BBAA, ABAB, AABB. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessor does not know the allocation
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
No. 83, Alley 4, Alley 1.1, Safashahr Street, Qom
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.MUQ.REC.1397.168
Health conditions studied
1
Description of health condition studied
Cough
ICD-10 code
R05
ICD-10 code description
Cough
Primary outcomes
1
Description
Number of cough attacks per day
Timepoint
7 and 14 days after intervention
Method of measurement
Patient statement
2
Description
Number of coughs per attack
Timepoint
7 and 14 days after intervention
Method of measurement
Patient statement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pregabalin capsule, oral, 150 mg, every 12 hours for two weeks
Category
Treatment - Drugs
2
Description
Control group: placebo capsule, oral, every 12 hours for two weeks