Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000847213p
Ethics application status
Submitted, not yet approved
Date submitted
8/05/2018
Date registered
21/05/2018
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of single dose dexamethasone in the management of sore throat.
Scientific title
Efficacy of single dose dexamethasone in the management of sore throat in primary care setting- Randomized Controlled Trail
Secondary ID [1] 294832 0
Nil known
Universal Trial Number (UTN)
U1111-1213-7168
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sore throat 307779 0
viral infection 307780 0
respiratory infection 307802 0
Condition category
Condition code
Infection 306823 306823 0 0
Other infectious diseases
Respiratory 306852 306852 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients with sore throat due to viral etiology will be randomized in to two groups. One group will receive single dose oral ( tablet) dexamethasone ( 10 mg ) and symptomatic treatment and the other group will be given the symptomatic treatment only.
the medication will be given in the health center under direct observation of the study personnel
Intervention code [1] 301145 0
Treatment: Drugs
Comparator / control treatment
the control group will receive the symptomatic treatment of sore throat with out the studied medication. follow up and the rest of care will be the same.
The symptomatic treatment include antihistamine and antipyretics.
The symptomatic treatment is the usual up to date treatment of this condition.
Control group
Active

Outcomes
Primary outcome [1] 305809 0
A change in the patient subjective rating of her or his pain. using the visual analogue scale.
Timepoint [1] 305809 0
the change in the patient rating of her or his pain will be check at T0, T12 hours, T24 hours and T48 HOURS post treatment,
the primary end point is T24
Secondary outcome [1] 346651 0
1. time to complete symptoms resolution (VAS=0)
the patients will be given the visual analogue scale and will be asked to fill it and to make the time when they have zero pain
Timepoint [1] 346651 0
1. Will check when the patient has Visual analogue scale equal to zero which means has no pain. we will follow up the patient till 7 days post treatment.
Secondary outcome [2] 346736 0
2. need for antibiotics prescription up to 7 days post treatment
Patient will receive a phone call. in addition the health system in out hospital is connected we plan to check the patient file if he visited the emergency room and antibiotics is prescribed or not.
Timepoint [2] 346736 0
patient will be called at 7 days post treatment to check if they started antibiotics through out the week after treatment.
Secondary outcome [3] 346737 0
3. side effect of the studied mediation
this is self reported. patients will be asked about new symptoms started post treatment.
up to seven days.
Studies found that most of the symptoms noticed after the treatment are more related to the disease and are not real side effect of the medication.
the following side effects may be experienced:
1. nausea
2, vomiting
3. myalgia
4. hiccups
5. headache
Timepoint [3] 346737 0
patient will be called at one week post treatment to ask about any self reported side effects

Eligibility
Key inclusion criteria
All adult patients aged more than 18 years old present with sore throat will be invited to take part in the study.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are Pregnant or lactating, have history of recent use of inhaled or oral corticosteroid (one month), have history of current or recent use of antibiotics (one month), have adeno-tonsillectomy ( one month), have alternative clear diagnosis like pneumonia, or have immune deficiency status, are excluded from the study. In addition we plan to exclude also all patients who have clear indication for antibiotics according to the centor score. Those who have history of allergy to the studied medication or previous use of the medication with development of side effects are also 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)
sealed envelopes will be used for allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization ( block of 4)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power Analysis
After a follow-up of at least 24 hours, 74 patients will be needed (37 on each group) to have 90% power to detect an average mean difference of pain score of 2.1 from visual analogue scale between the two treatment arms (4.5 to 2.4) at the 5% alpha (significance) level. Because of missing data and losses to follow-up, an additional 26 subjects will be needed (50 in each arm) for a total of 100 subjects (study sample).

Statistical Analysis
Descriptive statistics will be used to describe the data. For categorical variables, frequencies and percentages will be reported. Differences between groups will be analyzed using Pearson’s ( statistical test applied to sets of categorical data to evaluate how likely it is that any observed difference between the sets arose by chance.) tests. For continuous variables, mean and standard deviation will be used to present the data while analysis will be performed using Student’s t-tests. For non-normal distributed continuous variables, median and interquartile range (IQR) will be used to summarize the data and analysis performed using Wilcoxon-Mann-Whitney tests. An a priori two-tailed level of significance will be set at <0.05 level. Statistical analyses will be conducted using STATA version 13.1 (STATA Corporation, College Station, TX, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2018
Actual
Date of last participant enrolment
Anticipated
27/08/2018
Actual
Date of last data collection
Anticipated
3/09/2018
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10384 0
Oman
State/province [1] 10384 0
Muscat

Funding & Sponsors
Funding source category [1] 299427 0
Hospital
Name [1] 299427 0
Sultan Qaboos University Hospital
Country [1] 299427 0
Oman
Primary sponsor type
Individual
Name
Asma Al Shidhani
Address
Sultanate Of Oman-Muscat,
College of Medicine and Health Sciences, Sultan Qaboos University Hospital, PO 35, PC 123 Muscat.
Country
Oman
Secondary sponsor category [1] 298714 0
None
Name [1] 298714 0
Address [1] 298714 0
Country [1] 298714 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300328 0
Sultan Qaboos University Ethical Approval Committee
Ethics committee address [1] 300328 0
Sultanate Of Oman
Muscat
college of medicine and health sciences
PO 35
PC 123 Muscat
Ethics committee country [1] 300328 0
Oman
Date submitted for ethics approval [1] 300328 0
29/03/2018
Approval date [1] 300328 0
Ethics approval number [1] 300328 0

Summary
Brief summary
We aim to conduct a prospective randomized single blinded trail in the family medicine clinic and student clinic in the Sultan Qaboos University Hospital to assess the effectiveness of steroid in the management of sore throat. All adult patients aged more than 18 years old present with sore throat will be invited to take part in the study. The primary end point of evaluation is a change in the patient subjective rating of her or his pain. Patients who will be included will be randomized to either arms of the stuy. Each participant will be given an envelope which has either dexamethasone 10 mg (5 tablets, each of 2 mg) and the symptomatic treatment) ---or---- symptomatic treatment only together with the visual analogue score. Both treatment arms will be given the symptomatic treatment. The symptomatic treatment which is planned to be given includes antihistamin and antipyretic which are the usual treatment of sore throat. Patients will be asked to rate their pain on a visual analogue scale (VAS) from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. On enrolment, demographics, presenting symptoms and the VAS score for pain will be collected. Telephone follow-up will be performed as close to 12 hours and 24 hours and 48 hours after treatment as possible. During each telephone follow-up, patients will be asked to rate their current pain by using the VAS and to provide the time of initial onset of pain relief and the time of complete resolution of pain. The study will look at the following secondary outcome: time to complete symptoms resolution (VAS equal to zero), need for antibiotics prescription up to 7 days post treatment and self-reported side effects.



The study has two arms. Both arms will receive the usual symptomatic treatment which include antihistamine and antipyretic. The intervention group will be given dexamethasone in addition to the usual symptomatic treatment, The control group will not be given it. Both groups will have the same follow up plan.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2673 2673 0 0
/AnzctrAttachments/375064-consent final.pdf (Participant information/consent)
Attachments [2] 2674 2674 0 0
/AnzctrAttachments/375064-demographic data.pdf (Participant information/consent)
Attachments [3] 2675 2675 0 0
/AnzctrAttachments/375064-effectiveness of steroid management VAS.pdf (Participant information/consent)
Attachments [4] 2676 2676 0 0
/AnzctrAttachments/375064-????? ???????? ??????.pdf (Participant information/consent)
Attachments [5] 2677 2677 0 0
/AnzctrAttachments/375064(v08-05-2018-21-01-02)-????? ???????? ??????.pdf (Participant information/consent)

Contacts
Principal investigator
Name 83314 0
Dr Asma Al Salmani
Address 83314 0
Sultanate Of Oman
Muscat
college of medicine and health sciences
PO 35
PC 123 Muscat
Country 83314 0
Oman
Phone 83314 0
+96899881855
Fax 83314 0
Email 83314 0
[email protected]
Contact person for public queries
Name 83315 0
Dr Asma Al Salmani
Address 83315 0
Sultanate Of Oman
Muscat
college of medicine and health sciences
PO 35
PC 123 Muscat
Country 83315 0
Oman
Phone 83315 0
+96899881855
Fax 83315 0
Email 83315 0
[email protected]
Contact person for scientific queries
Name 83316 0
Dr Asma Al Salmani
Address 83316 0
Sultanate Of Oman
Muscat
college of medicine and health sciences
PO 35
PC 123 Muscat
Country 83316 0
Oman
Phone 83316 0
+96899881855
Fax 83316 0
Email 83316 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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