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NCT Number: NCT02576808

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

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.

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Key information

Conditions

Rhinitis,Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ginger Extract

Drug

Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days

Loratadine

Drug

Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days

Other names: Clarityne

Primary outcomes

  1. Nasal symptom

    Time frame: 42days

    Nasal symptom from Total nasal symptom score

Secondary outcomes

  1. Quality of Life

    Time frame: 42days

    Quality of Life from Rhinoconjunctivitis Quality of Life Questionnaire

  2. Nasal patency

    Time frame: 42days

    Nasal patency from Acoustic rhinometry

Sponsors and collaborators

Lead sponsor

Thai Traditional Medical Knowledge Fund

Other Gov

Collaborators

  • Thammasat University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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