Evaluation of the efficacy of nasal spray formulation containing tea tree oil in the treatment of seasonal allergic rhinitis

Evaluation of the efficacy of nasal spray formulation containing tea tree oil in the treatment of seasonal allergic rhinitis: a randomized double-blind placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210718051920N2

Enrollment

Registered

2021-07-31

Start date

2021-07-27

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

Seasonal allergic rhinitis. Other seasonal allergic rhinitis

Interventions

Intervention 1: Intervention group 1: patients will receive a puff of the nasal spray containing tea tree oil two times per day for 14 days. Intervention 2: Intervention group 2: patients will receive

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Seasonal allergic rhinitis confirmed by skin prick test

Exclusion criteria

Exclusion criteria: Structural disorders of the nose such as nasal polyps, nasal deviation and other structural disorders Asthma Chronic obstructive pulmonary disease (COPD) Rhinosinusitis Chronic diseases such as kidney failure, liver failure, hypertension, diabetes, ischemic heart disease, Malignancy, and systemic inflammatory diseases Respiratory infections during the previous 8 weeks Use of oral corticosteroids during the previous week Pregnancy Lactation Patients who are receiving immunotherapy or have a history of immunotherapy

Design outcomes

Primary

Measure	Time frame
The severity of the symptoms of seasonal allergic rhinitis. Timepoint: At the initiation of the study and every day. Method of measurement: Total nasal symptom score (TNSS).	—

Secondary

Measure	Time frame
Control of the symptoms of seasonal allergic rhinitis. Timepoint: At the beginning of the study and at the end of the first and second weeks of the study. Method of measurement: Rhinitis Control Assessment Test questionnaire.;Quality of life. Timepoint: At the beginning of the study and at the end of the first and second weeks of the study. Method of measurement: Mini rhinoconjunctivitis quality of life questionnaire (Mini RQLQ).	—

Measure

Time frame

Control of the symptoms of seasonal allergic rhinitis. Timepoint: At the beginning of the study and at the end of the first and second weeks of the study. Method of measurement: Rhinitis Control Assessment Test questionnaire.;Quality of life. Timepoint: At the beginning of the study and at the end of the first and second weeks of the study. Method of measurement: Mini rhinoconjunctivitis quality of life questionnaire (Mini RQLQ).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Forootanfar

Kerman University of Medical Sciences

forootanfar@yahoo.com+98 34 3132 5238

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026