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Trial registered on ANZCTR


Registration number
ACTRN12613000817741
Ethics application status
Approved
Date submitted
19/07/2013
Date registered
24/07/2013
Date last updated
30/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of effect of honey with cough syrups containing dextromethorphan and codeine on cough associated with upper respiratory tract infection in adults: a randomized trial
Scientific title
In patients with cough associated with upper respiratory tract infection , is honey better than cough syrups containing dextromethorphan and codeine in improving cough.
Secondary ID [1] 282883 0
NIL
Universal Trial Number (UTN)
U1111-1145-7723
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cough associated with Upper respiratory tract infections 289658 0
Condition category
Condition code
Respiratory 289978 289978 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 290034 290034 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There were two treatment groups in the study. One group received honey 30 ml per day in three divided doses for 3 days (10 ml three times a day)per oral with the measured spoon given with the intervention
Pure bee honey (langnese) was used.
To ensure patient adherence to medicines, a reminder phone call at day 2 of treatment was given to the patients by study coordinator. a card was also given to patient to record their daily doses.
Intervention code [1] 287542 0
Treatment: Other
Comparator / control treatment
The other group received equivalent therapeutic dose of cough syrup containing Dextromethorphan (10 mg/5ml) and pseudoephedrine (30 mg/5 ml) 30 ml per day in three divided doses (maximum dose dextromethorphan 80 mg/day and pseudoephedrine 240mgs /day in three or four divided doses) for three days
To ensure patient adherence to medicines, a daily reminder phone call at day 2 of treatment was given to the patients by study coordinator. a card was also given to patient to record their daily doses.
Control group
Active

Outcomes
Primary outcome [1] 290026 0
improvement in the frequency of cough
assessed by a 7 point likert scale by patients
Timepoint [1] 290026 0
baseline and after 3 days after treatment commencement
Primary outcome [2] 290027 0
Improvement in the severity of cough
assessed by a 7 point likert scale by patients
Timepoint [2] 290027 0
After 3 days of treatment
Primary outcome [3] 290028 0
Improvement in the bothersome nature of cough
assessed by a 7 point likert scale by patients
Timepoint [3] 290028 0
after 3 days of treatment
Secondary outcome [1] 303801 0
night sleep quality
assessed by a 7 point likert scale by patients
Timepoint [1] 303801 0
after 3 days of treatment
Secondary outcome [2] 303889 0
combined score by adding all four variables
Timepoint [2] 303889 0
assessd at the time of anaylsis by combining all four variables

Eligibility
Key inclusion criteria
We included all patients 18-65 years of age presenting within 7 days history of cough due to URI visiting Community health center, Aga khan university hospital, not requiring antibiotics.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with signs or symptoms of pneumonia, asthma or COPD exacerbation, already taking honey or any cough syrups, using drugs known to inhibit the metabolism of dextromethorphan and pseudoephridine (such as selective serotonin reuptake inhibitor), history of Diabetes Mellitus, using ACE inhibitors,current smoker, not providing consent and pregnant women were excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A detailed presentation was conducted by the Primary investigator for the family physicians working in Community health center (CHC) to introduce them to the study and its methodology. Consent was obtained from CHC supervisors before conducting the study. Promotional pamphlets containing information about the study, referral criteria and pager number/contact number of primary investigator and study co-coordinator were pasted in all clinic rooms along with the supervisor room in CHC. Trained study coordinator was responsible for enrolment of patients, data collection, and administration of intervention. Patients were diagnosed on the basis of detailed history and clinical examination and referred to study coordinator by the physicians. These patients were reassessed by the study coordinator and enrolled if they fulfilled the study’s eligibility criteria. Patients not fulfilling the criteria were sent back to their primary physician. according to the sample size 86 sequentially numbered opaque envelopes containing either intervention were prepared with envelopes containing honey labelled as "0" and those containing cough syrup as "1". The study coordinator who was unaware of the randomization sequence, assigned the envelopes to the patients sequentially in the order as he enrolled the patients in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Before the conduct of the study, using SPSS software, a random sample of 43 subjects from a total of 86 sequentially numbered subjects were selected . These subjects were assigned to one of the intervention group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data was double entered and analysed on Statistical Package for Social Sciences (SPSS) version 16. All analysis was done on intention to treat basis. For the continuous variable age of the patient, means and standard deviations were computed. Frequencies and percentages for the categorical variables such as gender, socioeconomic status, education level, smoking status, previous treatment taken during this course of illness and duration of illness in days (< 3 days, 3-6 days) were computed. Baseline characteristics were compared between the two treatment groups using a 2 test of independence for categorical variables and t-test for continuous variables.
Cough symptom scores were obtained from patients on the Likert scale at base-line and at follow-up on third day for frequency, severity, and bothersome nature of cough, and night sleep disturbance. The combined score at baseline and at Day 3 was computed by summing the four symptom scores respectively. We assessed the improvement in cough outcomes by taking difference between the baseline and the follow up scores. As cough outcome scores showed departure from normality, non-parametric Mann-Whitney U-test was used to compare median of the differences of scores in the two groups. Higher mean rank denotes better improvement in a treatment group. A p-value of less than 0.05 was taken as significant.

Sample Size Calculation:

With 80% power, two sided significance level as 5%, standard deviation taken as 1.5 (1) and the minimum difference to be detected in improvement in cough symptoms in both the two groups as 1, the sample size came out to be 35 in each group (Software for sample size determination in health studies by WHO). Sample size was inflated by about 20% to encounter lost loss to follow-up as shown in previous studies. Hence a total of 43 patients in each arm were required to maintain the adequate power.

1)Paul IM, Yoder KE, Crowell KR, Shaffer ML, McMillan HS, Carlson LC, Dilworth DA, Berlin CM, Jr.: Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics 2004, 114(1):e85-90

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
3/08/2009
Date of last participant enrolment
Anticipated
15/12/2009
Actual
3/02/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment outside Australia
Country [1] 5232 0
Pakistan
State/province [1] 5232 0
Karachi/Sindh

Funding & Sponsors
Funding source category [1] 287640 0
University
Name [1] 287640 0
Student research grant
community health sciences
Aga khan University Hospital
Country [1] 287640 0
Pakistan
Primary sponsor type
Individual
Name
Safia Bano (Principal investigator)
Address
Aga Khan University Hospital, Karachi
Stadium Road, P.O. Box 3500, Karachi 74800,
Sindh
Country
Pakistan
Secondary sponsor category [1] 286381 0
None
Name [1] 286381 0
Address [1] 286381 0
Country [1] 286381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289610 0
Ethical review committe (ERC ) Aga khan university
Ethics committee address [1] 289610 0
Ethics committee country [1] 289610 0
Pakistan
Date submitted for ethics approval [1] 289610 0
02/05/2009
Approval date [1] 289610 0
27/07/2009
Ethics approval number [1] 289610 0
1264-CHS/ERC-09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41518 0
Dr Safia Bano
Address 41518 0
R-53 Gulshan-e-Shamim, F.B Area- 8, Karachi, Sindh
Postal code 75950
Aga Khan University Hospital
Karachi, Sindh
Country 41518 0
Pakistan
Phone 41518 0
+92 345 2650526
Fax 41518 0
Email 41518 0
dr_safia.bano@yahoo.com
Contact person for public queries
Name 41519 0
Safia Bano
Address 41519 0
R-53 Gulshan-e-Shamim, F.B Area- 8, Karachi, Sindh
Postal code 75950

Aga Khan University Hospital
Karachi, Sindh
Country 41519 0
Pakistan
Phone 41519 0
+92 345 2650526
Fax 41519 0
Email 41519 0
dr_safia.bano@yahoo.com
Contact person for scientific queries
Name 41520 0
Safia Bano
Address 41520 0
R-53 Gulshan-e-Shamim, F.B Area- 8, Karachi, Sindh
Postal code 75950

Aga Khan University Hospital
Karachi, Sindh
Country 41520 0
Pakistan
Phone 41520 0
+92 345 2650526
Fax 41520 0
Email 41520 0
dr_safia.bano@yahoo.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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