Comparative Study of Efficacy and Adverse Effects of Ginger Extract and Loratadine for Treatment of Allergic Rhinitis Patients (Clinical Trial Phase II)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Nasal symptom
Study Overview
Brief Summary
Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients compared with Loratadine.The double blind randomized controlled trial study was approved by the Human Research Ethics Committee of Thammasat University NO.1.
Detailed Description
The double blind randomized controlled trial study. Patients who meet the inclusion criteria and do not fall into any exclusion criteria will be randomly placed into the experimental group, who will receive ginger extract capsules, or the control group, who will receive loratadine for 42 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients have moderate allergic rhinitis (itching and nasal obstruction, watery nasal discharge, sneezing and congestion )with a minimum total nasal symptom score 7 point
- •These patients do not have the respiratory disease such as tuberculosis, nasal polyps.
- •These patients do not have the history of disease: heart disease, kidney disease, liver disease, epilepsy, high blood pressure and severe asthma.
- •These patients are not pregnant or breastfeeding.
- •These patients have normal BMI and vital signs.
Exclusion Criteria
- •Those who have taken anti-coagulant and anti-platelet aggregation medications.
- •Those who get serious side effects from Loratadine and ginger allergy.
- •Communication problems especially listening and interview.
Arms & Interventions
Ginger extract
Drug
Intervention: Ginger extract (Drug)
Loratadine
Drug
Intervention: Loratadine (Drug)
Outcomes
Primary Outcomes
Nasal symptom
Time Frame: 42days
Nasal symptom from Total nasal symptom score
Secondary Outcomes
- Quality of Life(42days)
- Nasal patency(42days)
Investigators
Rodsarin Yamprasert
Faculty of Medicine Thammasat University
Thai Traditional Medical Knowledge Fund