Comparison Therapeutic Effects of Ketotifen Fumarate Drop and Ketotifen Pill in Patients with Allergic Rhinitis

Effects of Ketotifen Fumarate Drop and Ketotifen Pill on Symptom Severity, Quality of Life and Nasal Smear Eosinophil Percent in Allergic Rhinitis Patients: a Randomized Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014051617413N3

Enrollment

140

Registered

2014-08-21

Start date

2014-04-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

allergic rhinitis. Vasomotor and allergic rhinitis

Interventions

Intervention 1: Ketotifen fumarate 0.025% drop, one drop in each side of nose every 12 hours, and placebo pills every 12 hours, for four weeks. Intervention 2: Placebo (distilled water) drop, one drop

Treatment - Drugs

Ketotifen fumarate 0.025% drop, one drop in each side of nose every 12 hours, and placebo pills every 12 hours, for four weeks

Placebo (distilled water) drop, one drop in each side of nose every 12 hours, and ketotifen pills, 1 mg every 12 hours, for four weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Mild allergic rhinitis patients referred to Baqiyatallah University of Medical Sciences Allergy Clinic without any age and gender limitations. Exclusion criteria: Patients consuming antihistamines and corticosteroids; refractory to antihistamines and leukotriene receptor antagonists; patients with asthma; acute and chronic rhino-sinusitis; polyposis; consuming tricyclic antidepressants; allergy to ketotifen

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Rhinorrhea severity. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: visual analogue score (0-10).;Itchy nose severity. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: visual analogue score (0-10).;Quality of life. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: Rhino-conjunctivitis quality of life questionnaire (RQLQ).;Eosinophil percent for nasal smears. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: Nasal smears laboratory test.;Nasal obstruction severity. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: visual analogue score (0-10).	—

Measure

Time frame

Rhinorrhea severity. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: visual analogue score (0-10).;Itchy nose severity. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: visual analogue score (0-10).;Quality of life. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: Rhino-conjunctivitis quality of life questionnaire (RQLQ).;Eosinophil percent for nasal smears. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: Nasal smears laboratory test.;Nasal obstruction severity. Timepoint: Before treatment, two weeks and four weeks after treatment. Method of measurement: visual analogue score (0-10).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Karimi Sari

Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran

dr.karimih@yahoo.com+98 21 8126 4354

Outcome results

None listed

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