The clinical efficacy of Platanus orientalis L. distillate, as nasal drop, in allergic rhinitis- a pilot, randomized, double-blind, placebo-controlled clinical trial
Observing the efficacy of Platanus orientalis L. distillate in allergic rhinitis symptoms
Design
A clinical pilot study, randomized, placebo-controlled, double blind
Sample size: 30 patients
Permuted block randomization was applied.
Settings and conduct
Thirty patients are selected randomly among the patients referred to Emam Reza Clinic, Shiraz. They are asked to use the drop 4 times a day for one month and record daily symptoms. The probable side effects are recorded. Local and systemic corticosteroids are prohibited. Clinical symptoms are scored.
Participants/Inclusion and exclusion criteria
Thirty patients.
Inclusion criteria:
Patients aged 18-65 years
Obtaining the informed consent
Fulfillment of allergic rhinitis diagnostic criteria and the history of allergic rhinitis for at least two consecutive years
Exclusion criteria:
Pregnancy
Breast feeding
Females at age of fertility with no particular pregnancy prevention method
Systemic corticosteroid therapy in the past three months
Local corticosteroid therapy in the past fifteen days
Intervention groups
Intervention group: (Test medication: Platanus orientallis L. distillate)
Control group: (Placebo: Sterilized distilled water)
Main outcome variables
1- Allergic rhinitis symptom score (nose, eyes, respiratory), 2- Quality of life score (regular activities, recreational activities, sleep)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100218003361N2
Registration date:2018-12-30, 1397/10/09
Registration timing:registered_while_recruiting
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Soheila Alyasin
Name of organization / entity
Shiraz University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4298
Email address
alyasins@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-19, 1397/09/28
Expected recruitment end date
2019-05-19, 1398/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical efficacy of Platanus orientalis L. distillate, as nasal drop, in allergic rhinitis- a pilot, randomized, double-blind, placebo-controlled clinical trial
Public title
Evaluation of Platanus orientalis L. distillate effects on allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 years
Obtaining the informed consent
Fulfillment of allergic rhinitis diagnostic criteria and the history of allergic rhinitis for at least two consecutive years
Exclusion criteria:
Systemic corticosteroid therapy in the past three months
Local corticosteroid therapy in the past fifteen days
Pregnancy
Breast feeding
Females at age of fertility with no particular pregnancy prevention method
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method was applied. Random allocation software was used. Equal block sizes were used and based on the sample size (30) and two treatment groups, eight permuted blocks of four were produced. In this method, the number of test and control cases is equal in each block. All of the randomized permuted blocks of 4 are noted and in each step one of them is selected randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects and study personnel (including principal investigator) were blinded in this study. Nasal drops in placebo and test group were prepared in identical packages (with a number based on the randomization method) by research center personnel who were not associated with the subject’s clinical management, data collection and analysis, to ensure blinding.
Because of the similar packaging, placebo and test drops were not distinguishable.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Filling the daily symptom questionnaire and symptom scores by the patient
2
Description
Comparing the daily mean scores of allergic rhinitis
Timepoint
Day 1- Day 30
Method of measurement
Statistical analyses
3
Description
Quality of life score (regular activities, recreational activities, sleep)
Timepoint
At enrollment, at days 14 and 30
Method of measurement
Quality of life scoring in quality of life questionnaire
4
Description
Observing the variations in the severity of allergic rhinitis symptoms
Timepoint
Day 30
Method of measurement
Clinician evaluations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Platanus Orientalis L. distillate, prepared as nasal drop. It is applied 4 times a day for one month. Distillate is prepared in research center and is filled in the drop containers following filtration.
Category
Treatment - Drugs
2
Description
Control group: distilled water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic, Shiraz University of Medical Sciences
Full name of responsible person
Soheila Alyasin
Street address
Zand street, Namazi square
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soheila Alyasin
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Soheila Alyasin
Position
Associate Professor of Pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 36122268
Email
alyasins@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Soheila Alyasin
Position
Associate Professor of Pediatrics, Pediatric Immunology and Allergy specialist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 71 3612 2268
Email
alyasins@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Soheila Alyasin
Position
Associate Professor of Pediatrics, Pediatric Immunology and Allergy specialist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
-
Phone
+98 36122268
Email
alyasins@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available