Pilot experimental study for safety and efficacy of IND02 (standardized hydroalcoholic extract of Cinnamonum zeylanicum bark extract) in reducing symptoms of Seasonal Allergic Rhinitis.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000030279

Acronym

NIL

Enrollment

Registered

2018-01-12

Start date

2018-01-20

Completion date

2018-03-06

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

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.

Outcome results