Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study of Efficacy and Adverse Effects of Ginger Extract and Loratadine for Treatment of Allergic Rhinitis Patients (Clinical Trial Phase II)

Conditions
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Rhinitis,Allergic

Intervention / Treatment
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* Drug: Ginger extract
* Drug: Loratadine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginger extract<br>Drug | Drug: Ginger extract<br>* Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days<br>|
| Active Comparator: Loratadine<br>Drug | Drug: Loratadine<br>* Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days<br>* Other names: Clarityne;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal symptom | Nasal symptom from Total nasal symptom score | 42days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of Life from Rhinoconjunctivitis Quality of Life Questionnaire | 42days | 
| Nasal patency | Nasal patency from Acoustic rhinometry | 42days |