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

October 8, 2017 updated by: Rodsarin Yamprasert, Thai Traditional Medical Knowledge Fund

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang,, Pathumthani, Thailand, 12120
        • Thammasat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ginger extract
Drug
Drug: Ginger extract
Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days
Active Comparator: Loratadine
Drug
Drug: Loratadine
Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days
Other Names:
  • Clarityne

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thai Traditional Medical Knowledge Fund

Collaborators

Thammasat University

Investigators

  • Principal Investigator: Rodsarin Yamprasert, Faculty of Medicine Thammasat University (Rangsit Campus)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Actual)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 8, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-TM-4-077/57
  • TCTR20151001001 (Registry Identifier: Thai Clinical Trials Registry (TCTR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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