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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.
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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.
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Secondary ID [1]
293506
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NIL
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Universal Trial Number (UTN)
NIL
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Trial acronym
NIL
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Linked study record
NIL
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Health condition
Health condition(s) or problem(s) studied:
Seasonal Allergic Rhinitis
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Condition category
Condition code
Inflammatory and Immune System
304922
304922
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0
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Allergies
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Alternative and Complementary Medicine
305025
305025
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0
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Herbal remedies
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
299752
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Treatment: Other
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Comparator / control treatment
Placebo controlled - saline solution
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Day-time Nasal Symptom Score
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Assessment method [1]
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Timepoint [1]
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Baseline, days 1, 2, 3, 4, 5, 6, 7.
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Primary outcome [2]
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Rhinoconjunctivitis QOL (RQLQ)
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Assessment method [2]
304118
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Timepoint [2]
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Baseline and Day 7
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Secondary outcome [1]
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Quality of life as assessed by;
Perceived Stress Index (PSI)
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Assessment method [1]
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Timepoint [1]
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Baseline and Day 7
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Secondary outcome [2]
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Safety markers:
Electrolyte/liver function tests (Blood Samples)
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Assessment method [2]
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Timepoint [2]
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Baseline and Day 7
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Secondary outcome [3]
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Safety markers:
Full Blood Count (Blood Samples)
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Assessment method [3]
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Timepoint [3]
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Baseline and Day 7
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Secondary outcome [4]
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Quality of life as assessed by;
Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [4]
341163
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Timepoint [4]
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Baseline and Day 7
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Secondary outcome [5]
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Quality of life as assessed by;
Work Productivity and Activities Impairment–Allergy Specific (WPAI–AS)
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Assessment method [5]
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Timepoint [5]
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Baseline and Day 7
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/01/2018
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Actual
20/01/2018
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Date of last participant enrolment
Anticipated
16/04/2018
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Actual
6/03/2018
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Date of last data collection
Anticipated
24/04/2018
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Actual
22/03/2018
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
18214
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4005 - New Farm
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Funding & Sponsors
Funding source category [1]
298125
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Commercial sector/Industry
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Name [1]
298125
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Indus Biotech Private Limited
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Address [1]
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1.Rahul Residency, Off Salunkhe Vihar Road,
Kondhwa,Pune 411048
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Country [1]
298125
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India
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Primary sponsor type
Commercial sector/Industry
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Name
Evidence Sciences Pty. Ltd.
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Address
P.O. Box 1193 New Farm QLD 4005
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
297214
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Address [1]
297214
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Country [1]
297214
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Limited
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Ethics committee address [1]
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129 Glen Osmond Rd Eastwood SA 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
299142
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01/10/2017
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Approval date [1]
299142
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08/01/2018
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Ethics approval number [1]
299142
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Summary
Brief summary
The aim of the study is to use of an intranasal spray containing of IND02 (standardized hydroalcoholic extract of Cinnamonum zeylanicum bark extract) to determine if it is superior to placebo in reducing the severity of the symptoms of seasonal allergic rhinitis (SAR) over 7 days.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
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Contacts
Principal investigator
Name
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Dr Elizabeth Steels
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Address
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Evidence Sciences Pty. Ltd.
P.O. Box 1193 New Farm QLD 4005
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Country
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Australia
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Phone
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+61431003929
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Fax
79442
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Email
79442
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[email protected]
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Contact person for public queries
Name
79443
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Dr Elizabeth Steels
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Address
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Evidence Sciences Pty. Ltd.
P.O. Box 1193 New Farm QLD 4005
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Country
79443
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Australia
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Phone
79443
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+61431003929
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Fax
79443
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Email
79443
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[email protected]
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Contact person for scientific queries
Name
79444
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Dr Elizabeth Steels
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Address
79444
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Evidence Sciences Pty. Ltd.
P.O. Box 1193 New Farm QLD 4005
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Country
79444
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Australia
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Phone
79444
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+61431003929
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Fax
79444
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Email
79444
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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