Purpose of the study: Evaluation of the effect of Maa-al-shaeer (An Iranian Traditional Medicine product) on treatment of allergic rhinitis in comparison with Fexofenadine. In this study 80 patients with allergic rhinitis (according to ARIA guideline) that were referred to Baqiyatallah Hospital Clinic or Traditional Medicine Clinic of Shahid Beheshti University of Medical Sciences, are enrolled in the study and randomly divided into two groups of 40 (A & B). Patients who have received Corticosteroid within past two weeks or patients who have received antihistamines within the past one week before the beginning of the study or those who suffering from other systemic or autoimmune disorders are not enrolled in the study. Group A will receive Maa-al-Sheer (15 gram of powder in 250 cc lukewarm water twice daily) and group B will receive Fexofenadine (60 mg tablet twice daily) for a period of two weeks. Clinical symptoms (using JTFPP questionnaire) and paraclinical parameters (including blood eosinophil count, Ig-E, IFN-gamma, TGF-beta, IL-4, IL-17) will be evaluated and documented in the beginning and at the end of second week. After that the patients are advised not to use any medicine for one week. The symptom aggravation will be checked at the end of third week following one week of withdrawal of the drug (using RCAT questionnaire)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082323732N1
Registration date:2016-01-25, 1394/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Alireza Derakhshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8931
Email address
ar.derakhshan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Maa-al-shaeer (An Iranian Traditional Medicine product) on treatment of allergic rhinitis in comparison with fexofenadine
Public title
Effect of Maa-al-shaeer (An Iranian Traditional Medicine product) on treatment of allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients 7 years to 65 years old that according to the ARIA guideline and diagnosis of a pulmonologist have allergic rhinitis a
Exclusion criteria: Diffused Nasal Polyps; Pregnancy; history of allergy to Fexofenadine or barley; Celiac disease; systemic inflammatory diseases; using antihistamines during the last week before the beginning of the study; using Corticosteroids during the last 2 weeks before the beginning of the study; Using other antihistamine drugs during the study; using corticosteroid drugs during the study; Lack of consent from the patient to stay in the study for any reason; drug intolerance or allergic reactions
Age
From 7 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences Ethics Committee
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin , Tehran, Iran.
City
Tehran
Postal code
1985717443
Approval date
2015-09-27, 1394/07/05
Ethics committee reference number
IR.SBMU.RAM.REC.1394.237
Health conditions studied
1
Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30.4
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Clinical symptoms
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
JTFPP questionnaire and based on VAS
2
Description
IFN-gamma
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
Blood sample and measurement using RT-PCR
3
Description
IL-4
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
Blood sample and measurement using RT-PCR
4
Description
IL-17
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
Blood sample and measurement using RT-PCR
5
Description
TGF-beta
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
Blood sample and measurement using RT-PCR
6
Description
Ig-E levels
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
Blood sample / IU/ml
7
Description
Blood Eosinophil level
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
Blood sample / IU/ml
8
Description
nasal smear eosinophil count
Timepoint
Baseline and 2 weeks after intervention
Method of measurement
eosinophil count in nasal smear
Secondary outcomes
1
Description
symptom recurrence rate
Timepoint
Baseline and one week after the end of intervention
Method of measurement
RCAT questionnaire
2
Description
Levels of AST, ALT, BUN, Cr in the group taking the Ma-al-Shaeer to evaluate its effect on hepatic and renal function
Timepoint
Baseline and two weeks after intervention
Method of measurement
blood samples
Intervention groups
1
Description
Intervention group: Receiving 15mg of Maa-al-shaeer powder in 250cc water, twice a day for 2 weeks
Category
Treatment - Drugs
2
Description
Control Group: Receiving Fexofenadine tablets 60mg twice a day for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine Clinic of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Alireza Derakhshan
Street address
No.8 Shams Alley, Vali-e-Asr Street
City
Tehran
2
Recruitment center
Name of recruitment center
Baqiyatallah Hospital Clinic
Full name of responsible person
Dr.Mostafa Ghanei
Street address
Baqiyatallah Hospital, Mollasadra Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahmood Mosadegh
Street address
No.8 Shams Alley, Opposite of Tavanir St, Vali Asr St, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Alireza Derakhshan
Position
PhD student of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite of Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
aderakhshan@live.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahmood Khodadoost
Position
Associate Professor
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite of Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
mkhodadoost@lmo.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Alireza Derakhshan
Position
Ph.D student of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite of Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
aderakhshan@live.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)