Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis
Comparative Study of Efficacy and Adverse Effects of Ginger Extract and Loratadine for Treatment of Allergic Rhinitis Patients (Clinical Trial Phase II)
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 10, 2017
October 1, 2017
2 years
October 12, 2015
October 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Nasal symptom
Nasal symptom from Total nasal symptom score
42days
Secondary Outcomes (2)
Quality of Life
42days
Nasal patency
42days
Study Arms (2)
Ginger extract
EXPERIMENTALDrug
Loratadine
ACTIVE COMPARATORDrug
Interventions
Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days
Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thai Traditional Medical Knowledge Fundlead
- Thammasat Universitycollaborator
Study Sites (1)
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120, Thailand
Related Publications (1)
Yamprasert R, Chanvimalueng W, Mukkasombut N, Itharat A. Ginger extract versus Loratadine in the treatment of allergic rhinitis: a randomized controlled trial. BMC Complement Med Ther. 2020 Apr 20;20(1):119. doi: 10.1186/s12906-020-2875-z.
PMID: 32312261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodsarin Yamprasert
Faculty of Medicine Thammasat University (Rangsit Campus)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty of Medicine Thammasat University
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 15, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
October 10, 2017
Record last verified: 2017-10