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Comparison the Efficacy of Plantago major Aqueous Extract with Cetirizine in Treatment of Acute Urticaria: a Double-blind, Randomized Controlled Trial

Protocol summary

Summary
In this prospective process, patients with acute urticaria who were referred to Razi, Loghman, and Shohadaye Tajrish hospitals in 1392 are studied. Inclusion criteria are age between 10 and 70 years old, negative history of autoimmune or immunodeficiency diseases, negative history of any specific drugs and willingness to participate in the study. Also, patients who received antihistaminic drugs or combination of corticosteroids a month before the trial, pregnant women, and patients with previous allergy to antihistamines or any ingredients in the herbal medicinal products will be excluded from the study. All patients will be informed about the project process and benefits and side effects of the drugs and the informed consent in order to participate in the project will be obtained.Then, patients will be divided into 2 groups, randomly. In the first group, plantago major aqueous extract in form of syrup will be administered twice a day and in the second group cetirizine syrup will be administered in the same way (Cetirizine is recommended as the first line of the second-generation antihistamine drugs in the treatment protocol of urticaria). A check list will be provided for each patient to document every urticaria lesions which have been experienced during the day. Patients will be examined on days 3 and 15 in person and on days 6 and 9 via phone call. In each check up, the scratching , resistance to therapy, and side effects will be examined. At the end of the treatment, patient's satisfaction will be questioned. The collected data will be analyzed by SPSS software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013082914519N1
Registration date: 2014-04-25, 1393/02/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-25, 1393/02/05
Registrant information
Name
Mohammad Ali Yazdian
Name of organization / entity
Ancient Medicine Faculty of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 2526
Email address
yazdian980@gmail.com
Recruitment status
Recruitment complete
Funding source
personal funding
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Efficacy of Plantago major Aqueous Extract with Cetirizine in Treatment of Acute Urticaria: a Double-blind, Randomized Controlled Trial
Public title
Comparison the Effects of Plantago major Aqueous Extract with Cetirizine in Treatment of Acute Urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 10 to 70 years old patients; no history of autoimmune or immunodeficiency disease; negative drug history; willingness to participate in the study Exclusion criteria: received antihistaminic drugs, or combination of corticosteroids a month before the trial; pregnancy; previous allergy to Antihistamines or any of the ingredients in the herbal medicinal products; unwillingness to participate in the study
Age
From 10 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Both patients and the researchers (who will examine the outcomes of the study) will be blind to the drugs used in the trial.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Building no.2, Shahid Beheshti University of Medical Sciences, Parvane St, Yaman St, Shahid Chamran Boulevard
City
Tehran
Postal code
Approval date
2013-12-29, 1392/10/08
Ethics committee reference number
144

Health conditions studied

1

Description of health condition studied
acute urticaria
ICD-10 code
L50.9
ICD-10 code description
Urticaria, unspecified

Primary outcomes

1

Description
amount of itching, drug resistance, and side effects
Timepoint
days 3 and 15
Method of measurement
visiting a dermatologist at the clinic

2

Description
number of urticarial lesions
Timepoint
every day
Method of measurement
Asking the patient

3

Description
amount of itching, drug resistance, and side effects
Timepoint
days 9 and 6
Method of measurement
Asking the patient

4

Description
satisfaction of treatment
Timepoint
At the end of the follow ups
Method of measurement
Asking the patient

Secondary outcomes

empty

Intervention groups

1

Description
The control group was treated with cetirizine syrup (Citirizine Tolid Daro Tehran Company), 5cc per day for 15 days.
Category
Treatment - Drugs

2

Description
the first group received 10% Plantago major aqueous extract, 5cc per day for 15 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi, Tajrish and Loghman Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ancient Medicine Faculty,Vice chancellor for research, Shahid Beheshti University of Medical Science
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Parvane St, Yaman St, Shahid Chamran Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ancient Medicine Faculty,Vice chancellor for research, Shahid Beheshti University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ancient Medicine Faculty, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Yazdian
Position
PhD Student
Other areas of specialty/work
Street address
Apartment no.8, Shams Avenue, Vali Asr St
City
Tehran
Postal code
Phone
+98 21 8877 3525
Fax
Email
yazdian980@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ancient Medicine faculty of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahmoud Khodadoost
Position
professor of the faculty
Other areas of specialty/work
Street address
Ancient Medicine faculty of Shahid Beheshti University of Medical Sciences, Shams Avenue, Tavanir, Vali Asr St
City
Tehran
Postal code
Phone
+98 21 8877 3525
Fax
Email
mkhodadoost@lmo.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Ali Yazdian
Position
PhD Student
Other areas of specialty/work
Street address
Apartment no.8, Shams Avenue, Vali Asr St
City
Tehran
Postal code
Phone
00
Fax
Email
yazdian980@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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