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Trial registered on ANZCTR


Registration number
ACTRN12618000030279
Ethics application status
Approved
Date submitted
2/12/2017
Date registered
12/01/2018
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot experimental study for safety and efficacy of IND02 (standardized hydroalcoholic extract of Cinnamonum zeylanicum bark extract) in reducing symptoms of Seasonal Allergic Rhinitis.
Scientific title
Pilot experimental study for safety and efficacy of IND02 (standardized hydroalcoholic extract of Cinnamonum zeylanicum bark extract) in reducing symptoms of Seasonal Allergic Rhinitis.
Secondary ID [1] 293506 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
Seasonal Allergic Rhinitis 305705 0
Condition category
Condition code
Inflammatory and Immune System 304922 304922 0 0
Allergies
Alternative and Complementary Medicine 305025 305025 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cinnamon (Cinnamonum zeylanicum) bark extract, nasal spray; 2 sprays/nostril twice a day; taken for 7 days. Equivalent to 100ul/ml of Cinnamon Bark extract per spray.
Intervention code [1] 299752 0
Treatment: Other
Comparator / control treatment
Placebo controlled - saline solution
Control group
Placebo

Outcomes
Primary outcome [1] 304117 0
Day-time Nasal Symptom Score
Timepoint [1] 304117 0
Baseline, days 1, 2, 3, 4, 5, 6, 7.
Primary outcome [2] 304118 0
Rhinoconjunctivitis QOL (RQLQ)
Timepoint [2] 304118 0
Baseline and Day 7
Secondary outcome [1] 341028 0
Quality of life as assessed by;
Perceived Stress Index (PSI)
Timepoint [1] 341028 0
Baseline and Day 7
Secondary outcome [2] 341029 0
Safety markers:
Electrolyte/liver function tests (Blood Samples)
Timepoint [2] 341029 0
Baseline and Day 7
Secondary outcome [3] 341162 0
Safety markers:
Full Blood Count (Blood Samples)
Timepoint [3] 341162 0
Baseline and Day 7
Secondary outcome [4] 341163 0
Quality of life as assessed by;
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [4] 341163 0
Baseline and Day 7
Secondary outcome [5] 341164 0
Quality of life as assessed by;
Work Productivity and Activities Impairment–Allergy Specific (WPAI–AS)
Timepoint [5] 341164 0
Baseline and Day 7

Eligibility
Key inclusion criteria
Trial Inclusion Criteria:
- Males and females aged between 18-75 years.
- Prepared to provide written informed consent.
- Defined as having Seasonal Allergic Rhinitis by their GP
- Symptoms established using the 9-question RAP and having a total nasal symptom score (TNSS) of at least 12
- Prepared to not use any of antihistamines for a week prior to the study or during the study
- Prepared to not use any of the intranasal steroids for 2 weeks prior to the study or during the study
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trial Exclusion Criteria:
- History of asthma (other than mild intermittent), nasal disorders (eg, deviated septum, nasal polyposis or chronic rhinosinusitis) that were clinically significant, acute or significant sinusitis or upper respiratory tract infection within 14 days of enrolment.
- Have a existing serious medical condition (eg, severe emphysema) that precludes participation.
- (women) If they are knowingly pregnant (or not had normal menstrual cycle in the previous month) to exclude pregnancy) or breast feeding.
- Had uncontrolled chronic diseases, and acute or chronic infections or cancer within last 5 years
- On prolonged (= 6 weeks) medication with corticosteroids, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
- Have an allergy to cinnamon.

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software using computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Efficacy:
Sample size of 23 participants per treatment group will provide 80% power to detect a Minimal Clinically Important Difference (MCID) of 0.5 in Day-time symptom score (DNSS) between active treatment verses placebo, if the DNSS is normally distributed with a SD of 0.50 change, with a significance level of (alpha) of 0.05 using a 2-sided 2-sample t-test. Assuming that 10% of participants may not be evaluable, a total of 30 participants per group is required.
Data analysis: Efficacy analyses will be carried out on intent-to-treat population, consisting of all participants who are randomized, exposed to at least 4 doses (2 days) of the study product, and then attended at least one follow-up check-in after treatment initiation. This will include data from withdrawn participants. Safety analyses were based on data of all participants who received at least one dose of study product.

All of the data will be expressed as mean ± standard deviation unless otherwise specified. Characteristic comparability between groups at baseline will be assessed by independent t-test for continuous data, or by Pearson chi-square test for categorical data. Changes from baseline of measured metabolic parameters at each visit will be analyzed individually between groups by independent t-test. In addition, each individual variable will be analyzed within group by repeated-measures analysis of variance. Pathology assessments at baseline and end of study will be statistically analyzed within group by paired t-test, and between groups by independent t-test. Throughout the analysis, the underlying distributional assumptions of the statistical models should have been met; otherwise, the corresponding nonparametric tests will be used. Interim Statistical Analysis: There will be no interim statistical analysis for efficacy or safety. The investigator will review adverse events as they arise.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2018
Actual
20/01/2018
Date of last participant enrolment
Anticipated
16/04/2018
Actual
6/03/2018
Date of last data collection
Anticipated
24/04/2018
Actual
22/03/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18214 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 298125 0
Commercial sector/Industry
Name [1] 298125 0
Indus Biotech Private Limited
Country [1] 298125 0
India
Primary sponsor type
Commercial sector/Industry
Name
Evidence Sciences Pty. Ltd.
Address
P.O. Box 1193 New Farm QLD 4005
Country
Australia
Secondary sponsor category [1] 297214 0
None
Name [1] 297214 0
Address [1] 297214 0
Country [1] 297214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299142 0
Bellberry Limited
Ethics committee address [1] 299142 0
Ethics committee country [1] 299142 0
Australia
Date submitted for ethics approval [1] 299142 0
01/10/2017
Approval date [1] 299142 0
08/01/2018
Ethics approval number [1] 299142 0

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

Contacts
Principal investigator
Name 79442 0
Dr Elizabeth Steels
Address 79442 0
Evidence Sciences Pty. Ltd.
P.O. Box 1193 New Farm QLD 4005
Country 79442 0
Australia
Phone 79442 0
+61431003929
Fax 79442 0
Email 79442 0
drbeth@evidencesciences.com.au
Contact person for public queries
Name 79443 0
Elizabeth Steels
Address 79443 0
Evidence Sciences Pty. Ltd.
P.O. Box 1193 New Farm QLD 4005
Country 79443 0
Australia
Phone 79443 0
+61431003929
Fax 79443 0
Email 79443 0
drbeth@evidencesciences.com.au
Contact person for scientific queries
Name 79444 0
Elizabeth Steels
Address 79444 0
Evidence Sciences Pty. Ltd.
P.O. Box 1193 New Farm QLD 4005
Country 79444 0
Australia
Phone 79444 0
+61431003929
Fax 79444 0
Email 79444 0
drbeth@evidencesciences.com.au

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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