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Effect of naltrexone in treatment of chronic urticaria: double-blinded randomized clinical trial

Protocol summary

Study aim
Effect of Naltrexone in treatment of chronic urticaria
Design
A Clinical trial study with control group, parallel groups, double-blinded, randomized with block randomization on 62 patient
Settings and conduct
This study is performed on 62 patients in Hazrat Rasool Hospital. Patients are randomly divided into intervention group and control group. blinding will be performed on patients, Researcher and outcome assessor. Patients will assessed for severity of itching, urticaria and quality of life.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of chronic urticaria based on clinical criteria, lack of response to standard treatment, patients of both males and females, age over 12 years/ Exclusion criteria: pregnancy, breast feeding, allergy to naltrexone, substance abuse
Intervention groups
Intervention group: Tab Cetrizine 10mg,One every 6 hours (manufactured by Abidi Co., Iran) ; Tab Famotidin 40 mg, One every 12 hours ( manufactured by Shafa Darou Co.Iran) and Tab Montellukast 10 mg, once daily (manufactured by Zahravi Co.Iran) as the main treatment that start from one week before the intervention, called wash out period. Then adding cap Nalteroxone 50 mg daily (manufactured by Alhavi Co.Iran) for 6 weeks./ Control group: baseline treatment and placebo Once daily
Main outcome variables
Primary outcome: Improve itching and urticaria based on (Weekly Urticaria Activity Score) UAS7 and (Visual Analogue Scale) VAS. Other outcome: Improve the quality of life based on ( Dermatologic Life Quality Index)DLQI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210407050878N1
Registration date: 2021-06-29, 1400/04/08
Registration timing: prospective

Last update: 2021-06-29, 1400/04/08
Update count: 0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Vahid Bakrani balani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3338 8955
Email address
bakranibalani.v@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of naltrexone in treatment of chronic urticaria: double-blinded randomized clinical trial
Public title
Effect of naltrexone in chronic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chronic urticaria based on clinical criteria Lack of response to standard treatment Patients of both males and females Age over 12 years
Exclusion criteria:
Pregnancy Breast feeding Allergy to naltrexone Substance abuse
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is done using the Sealedenvelope.com Site with block size of 4 and considering a unique code for each participant. To hide random allocation, the drug for each person is placed in a package whose envelope is opaque and a unique code is affixed to it.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding is performed for the following levels. Patient: Placebo is used which is similar to the main drug in terms of color, shape, appearance and smell. The received intervention is specified by the code and the researcher is not aware of the codes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medicine, Iran University of Medical Sciences
Street address
Faculty of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-05-10, 1400/02/20
Ethics committee reference number
IR.IUMS.FMD.REC.1400.115

Health conditions studied

1

Description of health condition studied
Urticaria
ICD-10 code
L50
ICD-10 code description
Urticaria

Primary outcomes

1

Description
Itching Score based on UAS7 (Urticaria Activity Score7)
Timepoint
Itching score based on UAS7 (Urticaria Activity Score7): During the week before beginning intervention, during the second week of intervention, during the fourth week of intervention
Method of measurement
Based on UAS7 (Urticaria Activity Score7)

2

Description
Urticaria Score based on UAS7 (Urticaria Activity Score7)
Timepoint
Urticaria score based on UAS7 (Urticaria Activity Score7): during the week before beginning intervention, during the second week of intervention, during the fourth week of intervention
Method of measurement
Based on UAS7 (Urticaria Activity Score7)

Secondary outcomes

1

Description
Itching score based on VAS (Visual Analogue Scale)
Timepoint
Before intervention, end of the second week of intervention, end of the fourth week of intervention
Method of measurement
Based on VAS (Visual Analogue Scale)

2

Description
Quality of life based on DLQI (Dermatologic Life Quality Index)
Timepoint
Before intervention, end of the second week of intervention, end of the fourth week of intervention
Method of measurement
Based on DLQI (Dermatologic Life Quality Index)

Intervention groups

1

Description
Intervention group: Tab Cetrizine 10mg,One every 6 hours (manufactured by Abidi Co., Iran) ; Tab Famotidin 40 mg, One every 12 hours ( manufactured by Shafa Darou Co.Iran) and Tab Montellukast 10 mg, once daily (manufactured by Zahravi Co.Iran) as the main treatment that start from one week before the intervention, called wash out period. Then adding cap Nalteroxone 50 mg daily (manufactured by Alhavi Co.Iran) for 6 weeks.
Category
Treatment - Drugs

2

Description
Control group: Tab Cetrizine 10mg,One every 6 hours (manufactured by Abidi Co., Iran) ; Tab Famotidin 40 mg, One every 12 hours ( manufactured by Shafa Darou Co.Iran) and Tab Montellukast 10 mg, once daily (manufactured by Zahravi Co.Iran) as the main treatment that start from one week before the intervention, called wash out period. Then adding cap Placeco 50 mg daily (manufactured by Alhavi Co.Iran) for 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Vahid Bakrani Balani
Street address
Hazrat Rasool Hospital, Niayesh St, Sattarkhan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4933
Fax
+98 21 6655 4933
Email
bakranibalani.v@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevalian
Street address
Deputy of research and technology, Iran University of Medical Sciences, Shahid Hemmat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
motevalian.a@iums.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vahid Bakrani Balani
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Allergy and Clinical Immunology
Street address
Hazrat Rasool Hospital, Niayesh St, Sattarkhan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4933
Fax
+98 21 6655 4933
Email
bakranibalani.v@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Hasan Bemanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and Clinical Immunology
Street address
Hazrat Rasool Hospital, Niayesh St., Sattarkhan Ave., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4933
Fax
+98 21 6655 4933
Email
mh.bemanian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vahid Bakrani Balani
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Allergy and Clinical Immunology
Street address
Hazrat Rasool Hospital, Niayesh St, Sattarkhan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4933
Fax
+98 21 6655 4933
Email
bakranibalani.v@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data can be shared after deidentifying participants
When the data will become available and for how long
Data will become available 6 months after publication
To whom data/document is available
Individual participant data only available for people working in academic institutions.
Under which criteria data/document could be used
-
From where data/document is obtainable
Dr. Bakrani Balani Vahid email address bakranibalani.v@iums.ac.ir
What processes are involved for a request to access data/document
The data will be sent on month after recieving the e-mail.
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