Health Condition 1: J308- Other allergic rhinitis Health Condition 2: L509- Urticaria, unspecified
Conditions
Interventions
Intervention1: Levocetirizine: Levocetirizine 5mg tablet. Administered orally as prescribed by physician for 7 days.
Control Intervention1: Nil: Nil
Sponsors
Dr Reddys Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: For Allergic Rhinitis 1. Male or female patients above 18 years of age with moderate-severe persistent or moderate-severe intermittent allergic rhinitis, and advised levocetirizine once daily evening treatment in routine clinical practice by treating physician 2. Present the general status of rhinitis as moderate or severe 3. Total nasal symptom scores greater than or equal to 6 points, with congestion. 4. One or more of the other symptoms present (itching, runny nose, and sneezing) with a score greater than or equal to 2 at the screening visit. For Urticaria: 1. Male or female patients above 18 years of age with chronic idiopathic urticaria (CIU) episodes of hives of characteristic wheal and flare appearance, occurring regularly, at least three times a week for a period of at least 6 weeks during the previous 3 months, without an identifiable cause. 2. Patients with at least 3 days of moderate or severe pruritus and wheals present at the start of the recruitment.
Exclusion criteria
Exclusion criteria: For Allergic Rhinitis: 1. Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants. 2. History of alcohol abuse or illicit drug use 3. Pregnancy or risk of pregnancy and lactating patients 4. Known hypersensitivity to the Levocetirizine components used during the clinical trial 5. Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy 6. Concomitant use of potent topical corticosteroids. For Urticaria: 1. Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants 2. History of alcohol abuse or illicit drug use 3. Participation in a clinical trial in the year before this study 4. Pregnancy or risk of pregnancy and lactating patients 5. Known hypersensitivity to the formula components used during the clinical trial 6. Other forms of urticaria, such as physical, drug-induced, acute, or cholinergic urticaria, had to be excluded. 7. Any systemic disease or dermatologic disease that would interfere with the evaluation of the symptoms. 8. Concomitant use of potent topical corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness End points: The following parameters will be assessed from Day 1 of the study till the end of the study. Urticaria: 1. Frequency of wheals 2. Size of the wheals 3. Duration of Pruritus 4. Self-reported WPAI assessment during working days Self-reported Stanford sleeplessness scale Allergic Rhinitis: 1. Patient reported Reflective Total Nasal Symptom Score(TNSS) 2. Overall improved patient health related quality of life. 3. Self-reported WPAI assessment during working days 4. Self-reported Stanford sleeplessness scaleTimepoint: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3) | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Rahul Rathod
Dr Reddys Laboratories Ltd
Outcome results
None listed