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Trial record 5 of 1210 for:    HISTAMINE

Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control

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ClinicalTrials.gov Identifier: NCT02561429
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University

Brief Summary:

Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy and safety of SPT were proved. The positive control of SPT is histamine.

In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some practice they use other concentration (1, 2.5 mg/ml).

This study will find the proper concentration of histamine for positive control use in SPT.


Condition or disease Intervention/treatment Phase
Immediate Hypersensitivity Procedure: SPT Not Applicable

Detailed Description:
Appropriate concentration of histamine positive control is important in interpretation the result of skin prick test.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Positive Control of Skin Prick Test
Study Start Date : July 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: SPT of histamine
SPT of histamine concentration 1, 5 and 10 mg/ml
Procedure: SPT
SPT of histamine concentration 1, 5 and 10 mg/ml




Primary Outcome Measures :
  1. Mean wheal diameters of SPT of different histamine concentrations. [ Time Frame: 1 years ]
    compare mean wheal diameters of histamine concentration 1,5, and 10 mg/ml


Secondary Outcome Measures :
  1. Mean wheal diameters of SPT of local and imported histamine positive concentration [ Time Frame: 1 year ]
    compare mean wheal diameters of imported histamine 1 mg/ml to local histamine



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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parcitipate person who attented allergy clinic, ENT clinic
  • Legible in Thai language

Exclusion Criteria:

  • Patient cannot withhold antihistamine drug
  • Pragnancy and lactation mother
  • comorbid disease such as cardiac disease, liver, renal, hypertension and severe asthma

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): NCT02561429


Locations
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Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nualanong Visitsunthorn, Prof Mahidol University

Publications of Results:
Other Publications:
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Responsible Party: Nualanong Visitsunthorn, Prof, Mahidol University
ClinicalTrials.gov Identifier: NCT02561429     History of Changes
Other Study ID Numbers: si645/2012
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs