The aim of this study is investigation effect of Silybum marianum and Panax ginseng on clinical signs and symptoms of allergic rhinitis.this is a randomized double blind clinical trial..This study is down on paitients with allergic rhinitis that are visited in Emam Ali clinic in Shahrecord. Inclusion criteria: 18-55 year old paitients with allergic rhinitis for two last years.
Exclusion criteria: Paitients with cardiac diseasis, asthma, high blood pressure, diabet melitus. Pregnancy and lactation. Paitients that use asprin, varfarin, anti hypertensive drugs and anti phsycotic drugs. Sample size is 180. The paitiens are divided to three groups: The first group are prescribed Panax ginseng capsule 500mg two times daily and standard medication, the second group are prescribed Silybum marianum capsule 140mg two times daily and standard medication and third group are prescribed standard medication only.This study is down in 2015/7/23 to 2015/12/21. The pimary outcomes are nasal discharg, nasal ichting and sneeze.The secondry outcoms are nasal obstrution or congestion and occular ichting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511206252N10
Registration date:2015-12-17, 1394/09/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-17, 1394/09/26
Registrant information
Name
Soroush Amani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
samani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciensis.
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation effect of Silybum marianum and Panax ginseng on clinical signs and symptoms of allergic rhinitis.
Public title
Investigation effect of Silybum marianum and Panax ginseng on allergic rhinitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-55 year old paitients with allergic rhinitis for two last years.
Exclusion criteria: Paitients with cardiac diseasis, asthma, high blood pressure, diabet melitus. Pregnancy and lactation. Paitients who use asprin, varfarin, anti hypertensive drugs and anti phsycotic drugs.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciencies
Street address
Kashani Avenue, Shahrekord
City
Shahrekod
Postal code
8815713471
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
93-7-28
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
sneezing
Timepoint
first day,seventh day,forteenth day,thirtieth day
Method of measurement
clinical evaluation
2
Description
nasal discharge
Timepoint
first day,seventh day,forteenth day,thirtieth day
Method of measurement
clinical evaluation
3
Description
nasal itching
Timepoint
first day,seventh day,forteenth day,thirtieth day
Method of measurement
clinical evaluation
Secondary outcomes
1
Description
Nasal obstraction or congestion
Timepoint
first day,seventh day, fourteenth day, thirtieth day
Method of measurement
clinical evaluation
2
Description
occular itching
Timepoint
first day,seventh day, fourteenth day, thirtieth day
Method of measurement
clinical evaluation
Intervention groups
1
Description
The intervention group 2 are prescribed Silybum marianum capsule 140mg two times daily and standard medication.
Category
Treatment - Drugs
2
Description
The control group are prescribed standard medication only.
Category
Treatment - Drugs
3
Description
The intervention group 1 are prescribed Panax ginseng capsule 500mg two times daily and standard medication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Soroush Amani MD
Street address
Shariati Avenue, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chansellor for Research, Shahrekord University of Medical Sciences
Full name of responsible person
Mahmood Mobasheri MD
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chansellor for Research, Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Kashsni Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
+98 38 3334 3004
Email
ifo@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)