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

Phase 2

Completed

• Conditions: Rhinitis,Allergic
• Interventions: Drug: Ginger extract; Drug: Loratadine

• Registration Number: NCT02576808
• Lead Sponsor: Thai Traditional Medical Knowledge Fund

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-08
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients have moderate allergic rhinitis (itching and nasal obstruction, watery nasal discharge, sneezing and congestion )with a minimum total nasal symptom score 7 point
2. These patients do not have the respiratory disease such as tuberculosis, nasal polyps.
3. These patients do not have the history of disease: heart disease, kidney disease, liver disease, epilepsy, high blood pressure and severe asthma.
4. These patients are not pregnant or breastfeeding.
5. These patients have normal BMI and vital signs.

Read More

Exclusion Criteria

1. Those who have taken anti-coagulant and anti-platelet aggregation medications.
2. Those who get serious side effects from Loratadine and ginger allergy.
3. Communication problems especially listening and interview.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginger extract	Ginger extract	Drug
Loratadine	Loratadine	Drug

Primary Outcome Measures

Name	Time	Method
Nasal symptom	42days	Nasal symptom from Total nasal symptom score

Secondary Outcome Measures

Name	Time	Method
Quality of Life	42days	Quality of Life from Rhinoconjunctivitis Quality of Life Questionnaire
Nasal patency	42days	Nasal patency from Acoustic rhinometry

Trial Locations

Locations (1)

Thammasat University Hospital; 🇹🇭 Khlong Luang,, Pathumthani, Thailand