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A clinical trial to study effectiveness and safety of Acrivastine capsules in comparison with Chlorpheniramine maleate tablets in patients suffering from allergic rhinitis

A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Acrivastine capsules in comparison with Chlorpheniramine maleate tablets in patients suffering from allergic rhinitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001368
Enrollment
200
Registered
2010-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Allergic rhinitis Health Condition 2: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: Acrivastine 8 mg capsules: One capsule thrice daily for 2 weeks Control Intervention1: Chlorpheniramine maleate 4 mg tablets: One tablet thrice daily for 2 weeks

Sponsors

Cadila Healthcare Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex of 18 to 65 years of age 2. Established diagnosis of allergic rhinitis 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy & Lactation. 2. Significant renal impairment. 3. Narrow-angle glaucoma, GI or GUT obstruction. 4. Patients with acute attack of bronchial asthma or those on corticosteroids. 5. Nasal structural abnormalities 6. Upper respiratory tract infection 7. Hypersensitivity to study medications 8. Patients with any other serious concurrent illness or malignancy 9. Continuing history of alcohol and / or drug abuse 10. Recent participation in another clinical trial

Design outcomes

Primary

MeasureTime frame
The change in the total symptom scoreTimepoint: 0,1,2 weeks

Secondary

MeasureTime frame
The change in the total and individual nasal and ocular symptom scoresTimepoint: 0,1,2 weeks

Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

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