A clinical trial to study effectiveness and safety of Acrivastine capsules in comparison with Chlorpheniramine maleate tablets in patients suffering from allergic rhinitis
- Conditions
- Allergic rhinitis, unspecified,
- Registration Number
- CTRI/2010/091/001368
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
This study is an open label, comparative, multicentric study comparing the safety and efficacy of Acrivastine 8 mg capsules and Chlorpheniramine maleate 4 mg tablets given thrice daily each for 2 weeks; in 200 patients with allergic rhinitis that will be conducted in India. The primary outcome measures will be the change in total symptom score of nasal and ocular symptoms during the course of study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1.Patients of either sex of 18 to 65 years of age 2.Established diagnosis of allergic rhinitis 3.Informed consent.
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 abnormalities6.Upper respiratory tract infection7.Hypersensitivity to study medications8.Patients with any other serious concurrent illness or malignancy9.Continuing history of alcohol and / or drug abuse10.Recent participation in another clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in the total symptom score 0,1,2 weeks
- Secondary Outcome Measures
Name Time Method The change in the total and individual nasal and ocular symptom scores 0,1,2 weeks
Trial Locations
- Locations (5)
Ashray Chest Centre, Vadodara
🇮🇳Vadodara, GUJARAT, India
Dr. Jafreys Indore Chest Centre, Indore
🇮🇳Indore, MADHYA PRADESH, India
Dr. Khippals Clinic, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Dr. Tarun Ojhas ENT Centre, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Shashwat Hospital & Research Centre, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
Ashray Chest Centre, Vadodara🇮🇳Vadodara, GUJARAT, IndiaDr Sonia DalalPrincipal investigator02652340012drsoniadalal@hotmail.com