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Trial record 2 of 10 for:    Recruiting, Not yet recruiting, Available Studies | "Histamine Antagonists"

Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines in Emergency Department.

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ClinicalTrials.gov Identifier: NCT03296358
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

Brief Summary:
A randomized, double-blinded, controlled trial of adding a short burst of corticosteroid to the conventional treatment of H1 antihistamines

Condition or disease Intervention/treatment Phase
Urticaria Allergy Drug: IV Dexamethasone Drug: Oral prednisolone Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Controlled Trial of Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 31, 2019


Arm Intervention/treatment
No Intervention: Control group
Chorpheniramine 10 mg/amp ; 1 ampule Cetirizine 10 mg 7 tabs OD as home medication
Experimental: Experiment 1
Chorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication
Drug: IV Dexamethasone
The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 1 and Experiment 2 groups would receive IV Dexamethasone in ED.
Other Names:
  • Decadron
  • Dexasone

Experimental: Experiment 2
Chorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication Oral prednisolone 5 mg 20 tabs ; 2*2 po pc as home medication
Drug: IV Dexamethasone
The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 1 and Experiment 2 groups would receive IV Dexamethasone in ED.
Other Names:
  • Decadron
  • Dexasone

Drug: Oral prednisolone
The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 2 groups would receive IV Dexamethasone in ED and Oral prednisolone as home medication.
Other Name: Orapred




Primary Outcome Measures :
  1. Itch score [ Time Frame: 60 mins ]
    letting the patients mark a cross on a straight line. The end of the left side of a line represents "0 = no itch at all", and the end of the right side of a line represents "10 = the worst itch ever possible". The patients aren't allowed to compare the previous VAS score before doing the cross.


Secondary Outcome Measures :
  1. Chronic urticaria incidence [ Time Frame: 1 week, 1 month ]
    Chronic urticaria incidence after the use of steroid compare with no steroid use in treatment.

  2. Itch score [ Time Frame: 0, 15, 30 mins ]
    letting the patients mark a cross on a straight line. The end of the left side of a line represents "0 = no itch at all", and the end of the right side of a line represents "10 = the worst itch ever possible". The patients aren't allowed to compare the previous VAS score before doing the cross.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients visit emergency room at King chulalongkorn memorial hospital (KCMH) age between 18-50 years who meet the following criteria of acute urticarial such as

    1. eruption of wheals, central swelling of various sizes, with or without surrounding erythema; with or without angioedema
    2. pruritus or occasional burning sensation
    3. skin returning to normal appearance, usually within 1-24 hours

Exclusion Criteria:

  1. patients who have urticarial for more than 48 hours
  2. have severe underlying disease such as heart disease, kidney disease, liver disease
  3. pregnancy
  4. history of CPM, steroid, antihistamines allergy
  5. history of antihistamine or steroid uses within 48 hours before ED visit
  6. diabetes mellitus
  7. suspected of more severe disease or severe allergic reaction
  8. patients who don't have puritus
  9. patients who have history of chronic urticaria

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): NCT03296358


Locations
Thailand
Chulalongkorn Hospital Recruiting
Pathum Wan, Bangkok, Thailand, 10600
Contact: Pakhawadee Palungwachira, Bachelor    66897704758    zaphyr_s@yahoo.com   
Principal Investigator: Pakhawadee Palungwachira, Bachelor         
Sub-Investigator: Katsara Vilaisri, Bachelor         
Sub-Investigator: Klongwong Musikatavorn, Bachelor         
Sponsors and Collaborators
Chulalongkorn University

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03296358     History of Changes
Other Study ID Numbers: 668/2017
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Chulalongkorn University:
Acute urticaria
Emergency department
Acute allergic syndrome
Corticosteroid
H1-Antihistamines
Chronic urticaria

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Histamine Antagonists
Histamine H1 Antagonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors