Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02576808
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 10, 2017
Sponsor:
Collaborator:
Thammasat University
Information provided by (Responsible Party):
Rodsarin Yamprasert, Thai Traditional Medical Knowledge Fund

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.

Condition or disease Intervention/treatment Phase
Rhinitis,Allergic Drug: Ginger extract Drug: Loratadine Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: Clarityne




Primary Outcome Measures :
  1. Nasal symptom [ Time Frame: 42days ]
    Nasal symptom from Total nasal symptom score


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576808


Locations
Layout table for location information
Thailand
Thammasat University Hospital
Khlong Luang,, Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thai Traditional Medical Knowledge Fund
Thammasat University
Investigators
Layout table for investigator information
Principal Investigator: Rodsarin Yamprasert Faculty of Medicine Thammasat University (Rangsit Campus)

Layout table for additonal information
Responsible Party: Rodsarin Yamprasert, Faculty of Medicine Thammasat University, Thai Traditional Medical Knowledge Fund
ClinicalTrials.gov Identifier: NCT02576808     History of Changes
Other Study ID Numbers: MTU-EC-TM-4-077/57
TCTR20151001001 ( Registry Identifier: Thai Clinical Trials Registry (TCTR) )
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loratadine
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs