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

Rhinitis,Allergic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576808
• Other study ID #: MTU-EC-TM-4-077/57
• Secondary ID: TCTR20151001001
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2015
• Last updated: October 8, 2017
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Thai Traditional Medical Knowledge Fund
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis,Allergic

Intervention

Drug:
• Ginger extract
Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days
• Loratadine
Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Khlong Luang,	Pathumthani

Sponsors (2)

Lead Sponsor	Collaborator
Thai Traditional Medical Knowledge Fund	Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal symptom	Nasal symptom from Total nasal symptom score	42days
Secondary	Quality of Life	Quality of Life from Rhinoconjunctivitis Quality of Life Questionnaire	42days
Secondary	Nasal patency	Nasal patency from Acoustic rhinometry	42days