search
Back to results

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

Primary Purpose

Rhinitis,Allergic

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Ginger extract
Loratadine
Sponsored by
Thai Traditional Medical Knowledge Fund
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis,Allergic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thammasat University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ginger extract

Loratadine

Arm Description

Drug

Drug

Outcomes

Primary Outcome Measures

Nasal symptom
Nasal symptom from Total nasal symptom score

Secondary Outcome Measures

Quality of Life
Quality of Life from Rhinoconjunctivitis Quality of Life Questionnaire
Nasal patency
Nasal patency from Acoustic rhinometry

Full Information

First Posted
October 12, 2015
Last Updated
October 8, 2017
Sponsor
Thai Traditional Medical Knowledge Fund
Collaborators
Thammasat University
search

1. Study Identification

Unique Protocol Identification Number
NCT02576808
Brief Title
Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis
Official Title
Comparative Study of Efficacy and Adverse Effects of Ginger Extract and Loratadine for Treatment of Allergic Rhinitis Patients (Clinical Trial Phase II)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thai Traditional Medical Knowledge Fund
Collaborators
Thammasat University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis,Allergic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginger extract
Arm Type
Experimental
Arm Description
Drug
Arm Title
Loratadine
Arm Type
Active Comparator
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
Ginger extract
Intervention Description
Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days
Intervention Type
Drug
Intervention Name(s)
Loratadine
Other Intervention Name(s)
Clarityne
Intervention Description
Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days
Primary Outcome Measure Information:
Title
Nasal symptom
Description
Nasal symptom from Total nasal symptom score
Time Frame
42days
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Quality of Life from Rhinoconjunctivitis Quality of Life Questionnaire
Time Frame
42days
Title
Nasal patency
Description
Nasal patency from Acoustic rhinometry
Time Frame
42days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodsarin Yamprasert
Organizational Affiliation
Faculty of Medicine Thammasat University (Rangsit Campus)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat University Hospital
City
Khlong Luang,
State/Province
Pathumthani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32312261
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs