Clinical assessment of herbal inhalation of Hydroalcoholic Extract of lavender, Coriandrum sativum, Zataria multiflora, Mentha piperita, in treatment of Sinus Headache: A Randomized Double Blind Clinical Trial
Determination of the Effect of Herbal Formulation on Sinus Headache in Patients
Design
In this study, 64 patients were classified into control and Intervention groups by stratified randomization method Based on age.
Settings and conduct
This double-blind clinical trial study is performed in Imam Ali sub-specialty clinic.
Participants/Inclusion and exclusion criteria
People with a history of sinusitis assessed by the physician, with no history of migraine headaches, having at least three other symptoms of sinusitis such as nasal congestion and people with pain in one or more than one sinuses.
Intervention groups
In the intervention group, every 8 hours, patients add 5 ml of the drug to 250 ml of boiling water and inhale the vapor of it for 15 minutes. The control group will be given the placebo exactly the same as an inhaled drug (without active ingredient); and Duration of the using drug is two weeks in both groups.
Main outcome variables
Headaches associated with sinusitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170705034918N2
Registration date:2018-09-09, 1397/06/18
Registration timing:retrospective
Last update:2018-09-09, 1397/06/18
Update count:0
Registration date
2018-09-09, 1397/06/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 6539
Email address
st-heidari.r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical assessment of herbal inhalation of Hydroalcoholic Extract of lavender, Coriandrum sativum, Zataria multiflora, Mentha piperita, in treatment of Sinus Headache: A Randomized Double Blind Clinical Trial
Public title
The effect of herbal inhalation of Hydroalcoholic Extract of lavender, Coriandrum sativum, Zataria multiflora, Mentha piperita, in treatment of Sinus Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with a history of sinusitis assessed by the physician.
People with no history of migraine headaches.
People having at least three other symptoms of sinusitis such as nasal congestion.
People with pain in one or more than one sinuses.
Exclusion criteria:
People who have ulcer in their mouth and nose.
People Having a history of allergy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomized collection will be done Based on age and gender; In such a way male and female patients will be assigned to the control and intervention group individually; and Randomization will be done by Random Allocation Software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Pharmaceutical and placebo products, with the same packaging, are categorized as A and B; And All phases of pharmaceutical formula and placebo preparation are carried out by a pharmacognosit co-worker. it should be noted that researcher and also patients will not be informed of the contents of any products.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahrekord University of Medical Sciences
Street address
Kashani Blvd, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.skums.rec.1396.87
Health conditions studied
1
Description of health condition studied
Sinus Headache
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Headaches
Timepoint
Before and two weeks after the intervention
Method of measurement
Based on VAS criteria
2
Description
Rhinorrhea
Timepoint
Before and two weeks after the intervention
Method of measurement
Self-reported
3
Description
Nasal congestion
Timepoint
Before and two weeks after the intervention
Method of measurement
Self-reported
4
Description
Dyspnea
Timepoint
Before and two weeks after the intervention
Method of measurement
Self-reported
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, every 8 hours, patients add 5 ml of the drug to 250 ml of boiling water and inhale the vapor of it for 15 minutes and the patients and researchers will not be aware of the contents of the drug and the placebo. The drug used in the intervention group contains a hydroalcoholic extracts of lavender, Coriandrum sativum, Zataria multiflora and Mentha piperita in a specified proportion according to the method mentioned in the British Pharmacopoeia, and the formulation will be prepared by the pharmacognostic colleagues. (Duration of the using drug is 14 days)
Category
Treatment - Drugs
2
Description
In the control group, patients will be given placebo every 8 hours, they add 5 ml of the placebo to 250 ml of boiling water and inhale the vapor of it for 15 minutes and Duration of the using placebo is 14 days. The placebo contains a Food coloring with no active ingredient and the same as the original medicine will be designed and packaged so the patients and researchers will not be aware of the contents of the the placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali sub-specialty clinic
Full name of responsible person
Maryam Kazemi
Street address
Shariati Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3224 2696
Email
heidari.reza1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Reza Heidari-souresgjani
Street address
Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Reza Heidari-soureshjani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Traditional Medicine
Street address
Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815894749
Phone
+98 38 3333 6539
Email
heidari.reza1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Zahra Lorigooini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 6692
Email
gueini.z@skmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Reza Heidari-soureshjani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Traditional Medicine
Street address
Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815894749
Phone
+98 38 3333 6539
Email
heidari.reza1995@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Personal information of patients is confidential.
When the data will become available and for how long
The beginning of the data access period is after collecting and analyzing them until the paper is published.
To whom data/document is available
Executor of plan
Under which criteria data/document could be used
In order to analyze and review the results of the study
From where data/document is obtainable
Executor of plan
What processes are involved for a request to access data/document
The Information is not given to people who are not responsible for the research.