The aim of this study is to evaluate the therapeutic effects of systemic steroid, coffee and/or honey in the treatment of patients with Persistent Postinfectious Cough (PPC). A total of approximately 130 adult participants who had experienced PPC longer than 3 weeks, are assigned into the following five groups. For all the participants a jam-like paste is prepared. Each 600 grams of the product consisted of "320 mg prednisolone" in the first group, "70 grams original instant coffee" in the second group, and "500 grams of honey" in the third group , "70 grams of instant coffee plus 500 grams of honey" in the forth group, and placebo for the fifth group. These participants are told to dissolve 25 grams of the prescribed product in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week. Frequency of cough is evaluated before and after the treatment and also a month after the intervention and is compared between five groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103034737N2
Registration date:2011-03-20, 1389/12/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-20, 1389/12/29
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
Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences and Health Services
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2011-04-01, 1390/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the therapeutic effect of "systemic steroid" and "honey plus coffee" on persistent postinfectious cough
Public title
A comparison of the therapeutic effect of "systemic steroid" and "honey plus coffee" on persistent postinfectious cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PPC for more than three weeks of duration, normal routine laboratory tests, no systemic disease, normal chest X-Ray, age between 21 and 65 years
Exclusion criteria: presence of any systemic disease, other causes of chronic cough
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
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
Ethic Committee in Medical Sciences Research, Deputy of Research and Technology, Baqiyatallah Univer
Street address
Sheikhbahaee St., Mollasadra Ave
City
Tehran
Postal code
Postcode: 14359 - P.
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
2684
Health conditions studied
1
Description of health condition studied
persistent post infectious cough (PPC)
ICD-10 code
J31.2
ICD-10 code description
Chronic pharyngitis
Primary outcomes
1
Description
Persistent postinfectious cough (PPC)
Timepoint
before and after the treatment
Method of measurement
frequency of cough: low (+), moderate (++), and high (+++)
Secondary outcomes
empty
Intervention groups
1
Description
Prednisolone: 25 grams of the jam-like paste
(Each 600 grams of the product consisted of "320 mg prednisolone" is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.
Category
Treatment - Drugs
2
Description
Coffee: 25 grams of the jam-like paste
(Each 600 grams of the product consisted of "70 grams of original instnt Coffee" is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.
Category
Other
3
Description
Honey: 25 grams of the jam-like paste
(Each 600 grams of the product consisted of 500 grams of Honey) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.
Category
Other
4
Description
Coffee and Honey: 25 grams of the jam-like paste
(Each 600 grams of the product consisted of 70 grams of original instant Coffee as well as 500 grams of Honey) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.
Category
Other
5
Description
Placebo: 25 grams of the jam-like paste
(Each 600 grams of the product consisted of Placebo) is dissolved in about 200 cc of warm water (under 60 degree C), and drink this solution every 8 hours for one week.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University Hospital
Full name of responsible person
Dr. Raeessi M. A.
Street address
Mollasadra Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mohammad Ali Raeessi + Baqiyatallah University of Medical Sciences and Health Services