A study to compare efficacy and safety of levocetrizine versus levocetrizine alongwith probiotic in allergic rhinitis patient

Comparative study of efficacy and safety of oral levocetrizine monotherapy to co-administration of oral levocetrizine with oral probiotic in patients with allergic rhinitis in a tertiary care teaching hospital Haldwani - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059620

Enrollment

285

Registered

2023-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: Levocetirizine and Probiotic 1.2 CFU Lactobacillus gasseri KS13, 0.15 CFU Bifidobacterium bifidum G9-1, 0.15 CFU Bifidobacterium longum MM-2: 10mg once daily and 1.5 billion CFU once da

Eligibility

Inclusion criteria

Inclusion criteria: 1. Seasonal/Throughout year rhinitis 2. Patients with a symptom severity score of least 6 out of 15 3. Patients who were not on any anti-allergy preparations for at least 15 days

Exclusion criteria

Exclusion criteria: 1. Patients below 18 years of age 2. Pregnant women 3. Allergic rhinitis with nasal polyps 4. Fungal rhinitis 5. Vasomotor rhinitis 6. Patients with history of asthma and non-allergic causes of rhinitis 7. Patients with rhinosinusitis other than allergic rhinitis 8. Patients with sino-nasal tumours 9. Recurrence/Post surgical rhinitis 10. Patients with co morbid condition (renal, hepatic, cardiac, endocrine) 11. Patient who will not come for follow-up visit

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the efficacy of Oral Levocetirizine versus Oral Levocetirizine and Oral Probiotics in patient with allergic rhinitis Outcome will be assessed by Change in the Total Nasal Symptom score throughout the study periodTimepoint: first day, 2nd week, 6th week, 12th week	—

Secondary

Measure	Time frame
1. Safety profile of Oral Levocetirizine versus Oral Levocetirizine and Oral Probiotics in patient with allergic rhinitis. Timepoint: first day, 2nd week, 6th week 12th wee;Measure the Quality of Life in patients of allergic rhinitis on Oral Levocetirizine versus Oral Levocetirizine and Oral Probiotics by Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).Timepoint: first day, 2nd week, 6th week, 12th week	—

Measure

Time frame

1. Safety profile of Oral Levocetirizine versus Oral Levocetirizine and Oral Probiotics in patient with allergic rhinitis. Timepoint: first day, 2nd week, 6th week 12th wee;Measure the Quality of Life in patients of allergic rhinitis on Oral Levocetirizine versus Oral Levocetirizine and Oral Probiotics by Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).Timepoint: first day, 2nd week, 6th week, 12th week

—

Countries

India

Contacts

Public ContactBhavana Srivastava

Government Medical College Haldwani

drsbhavana@gmail.com7895782824

Outcome results

None listed

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