Protocol summary

Study aim
Determination of the influence of Marjoram oil Extract (Origanum Vulgare) in treatment of chronic rhinosinusitis without nasal polyps compare with fluticasone spray and placebo, concomitant with Life style modification of Traditional Persian Medicine. Determination and comparison of mean scores of patients' symptoms (according to SNOT22 questionnaire) in marjoram group with fluticasone group before and after treatment. Determine and comparison the CT scan of patients (according to Lund Makey scale) in the Marjoram group with fluticasone before and after treatment. Determination and comparison of mean scores of patients' symptoms (according to SNOT22 questionnaire) in Marjoram group with placebo group before and after treatment. Determine and comparison the possible side effects of Marjoram and fluticason group. Determination of the frequency of major and minor symptoms in chronic rhinosinusitis in 3 groups after receiving the drug.
Design
In this research, 75 eligible patients referring to 5 Azar Hospital in Gorgan were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into 2 intervention and 1 control groups.
Settings and conduct
Patients who will be referred to "5 Azar Hospital in Gorgan" with diagnosis of chronic rhinosinusitis without polyp will be studied. This study is Randomized double-blind placebo-controlled clinical trial. Participants, clinical care provider, Investigator, outcome assessor, and data analyzers are also blinded in this research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- People with chronic sinusitis approved. This criteria contains the typical symptoms of chronic sinusitis, with or without appropriate medical treatment for more than 12 weeks. 2- Positive CT scan which indicates the opacity and swelling of the sinus mucosa. 3- Patients aged 18 to 60 years. 4- Fill the letter of satisfaction by the patient. No entry criteria: 1- Nose and sinus surgery in the last 5 years. 2- Antibiotic or topical corticosteroid use 15 days before entering the study. 3- Using oral corticosteroid 30 days before entering the study. 4- Moderate to severe asthma and mild asthma that has had an acute attack less than 30 days ago. 5- Aspirin- Exacerbated Respiratory Disease. 6- Active infections in the nose and sinuses. 7- Polyps in the nose. 8- Other diseases (neurogenic or psychiatric illness, malignancy, immunodeficiency) in the last 5 years, so that according to researcher, does not have the required qualifications to participate in the clinical trial. 9- Pregnancy.
Intervention groups
ّFirst group: recipient of Marjoram nasal spray, Decosalin nasal spray and Life style modification of Traditional Persian Medicine for 4 wk. Second group: recipient of Fluticasone nasal spray, Decosalin nasal spray and Life style modification of Traditional Persian Medicine for 4 wk. Third group: recipient of Sesame nasal spray, Decosalin nasal spray and Life style modification of Traditional Persian Medicine for 4 wk.
Main outcome variables
Comparison the scores of SNOT22 questionnaires before and after treatment in all three groups. Comparison the CT-scan scores before and after treatment in all three groups. Comparison the major and minor sinusitis symptoms in all three groups.

General information

Reason for update
Acronym
CRS
IRCT registration information
IRCT registration number: IRCT20161022030439N2
Registration date: 2018-01-30, 1396/11/10
Registration timing: registered_while_recruiting

Last update: 2018-01-30, 1396/11/10
Update count: 0
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
Seyed abdolreza Kamaneh
Name of organization / entity
Golestan univercity of medical scince
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 5923
Email address
dr.kamaneh@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental
Expected recruitment start date
1991-01-21, 1369/11/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the influence of Marjoram oil Extract (Origanum Vulgare) in treatment of chronic rhinosinusitis without nasal polyps with fluticasone spray and sesame oil, concomitant with Life style modification of Traditional Persian Medicine, (a randomized, double-blind, clinical trial)
Public title
The influence of Marjoram oil Extract (Origanum Vulgare) in treatment of chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: 1- People with chronic sinusitis approved by the Academy of Otolaryngology-Head and Neck Ligation. This criteria contains the typical symptoms of chronic sinusitis, with or without appropriate medical treatment for more than 12 weeks. 2- Positive CT scan which indicates the opacity and swelling of the sinus mucosa. 3- Patients aged 18 to 60 years. 4- Fill the letter of satisfaction by the patient
Exclusion criteria:
Nose and sinus surgery in the last 5 years Antibiotic or topical corticosteroid use 15 days before entering the study Using oral corticosteroid 30 days before entering the study Moderate to severe asthma and mild asthma that has had an acute attack less than 30 days ago Aspirin- Exacerbated Respiratory Disease Active infections in the nose and sinuses Polyps in the nose Other diseases (neurogenic or psychiatric illness, malignancy, immunodeficiency) in the last 5 years, so that according to researcher, does not have the required qualifications to participate in the clinical trial Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 75
Actual sample size reached: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 3 groups; cases and controls based on Simple Random Allocation (random numbers table)
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the drugs and the placebo are similar in size, shape, color and odor to prevent the bias in participants, clinical care provider and outcome evaluators. And each patient will get an unique code.
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan Univercity of Medical Sciences
Street address
Phalsaphy complex, Shast kola Road
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2018-01-17, 1396/10/27
Ethics committee reference number
IR.GOUMS.REC.1396.241

Health conditions studied

1

Description of health condition studied
Chronic sinusitis
ICD-10 code
j32.9
ICD-10 code description
Sinusitis (chronic) NOS

Primary outcomes

1

Description
cough
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

2

Description
Posterior nasal discharge
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

3

Description
Need to blow nose
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

4

Description
sneezing
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

5

Description
Runny nose
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

6

Description
Nasal obstruction
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

7

Description
Loss of smell or taste
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

8

Description
Thick nasal discharge
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

9

Description
Post-nasal discharge
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

10

Description
Ear fullness
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

11

Description
Dizziness
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

12

Description
Ear pain
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

13

Description
Facial pain/pressure
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

14

Description
Difficulty falling asleep
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

15

Description
Waking up at night
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

16

Description
Lack of a good night’s sleep
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

17

Description
Waking up tired
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

18

Description
Exhausted feeling during day
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

19

Description
Reduced productivity
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

20

Description
Reduce concentration
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

21

Description
Frustration or irritability
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

22

Description
sad
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

23

Description
Embarrassed
Timepoint
Before and the end of the intervention
Method of measurement
SNOTE22 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Prescribed in this group are:1- Marjoram oil nasal spray 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). At the beginning, the Origanum Vulgare from the Gorgan Mountains collected its Voucher Number (1613) and dried. In order to prepare the drug, its semi-weighed was mixed with sesame oil and kept in an incubator at 50 ° C for 72 hours, then passed through the filter and marjoram oil was extracted. In each drop of this extract, equivalent 0.017% of carvacrol is vailable. Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage.
Category
Treatment - Drugs

2

Description
Prescribed in this group are: 1- Fluticasone nasal spray 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage.
Category
Treatment - Drugs

3

Description
Prescribed in this group are: 1- Sesame oil nasal spray (placebo) 2 puffs in each nostril Q12h for 4 wk. 2- Decosalin nasal spray 2 puffs Q12h for 4 wk. 3- Life style modification of Traditional Persian Medicine (LTPM). Life style modification of Traditional Persian Medicine contain: 1- avoiding supination and cool weather contact with the forehead and face 2- nasal irritation and sneezing at the first days of treatment 3- intense physical activities 4- reducing consumptions of some vegetables, such as garlic and onions, as well as date palm during an acute illness phase 5- limiting daily sleep 6- reinforcing the brain by inhaling rose, apple and saffron aromas 7- foot massage.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
5 Azar Hospital
Full name of responsible person
Mona Mazidi
Street address
5 Azar Hospital – 5 Azar Blvd
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3222 0561
Fax
+98 17 3232 8363
Email
pr-5azar@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Qaraaty Maraieh
Street address
shast kola road- Gorgan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3242 1289
Email
honarvar@goums.ac.ir
Grant name
Grant code / Reference number
---
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Seyed Abdolreza Kamaneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unit 5, The residential complex of Najafinejad, 6th Farhang, 9th Sayyad, Martyr Sayyad shirazi Boulevard
City
Gorgan
Province
Golestan
Postal code
4917976136
Phone
+98 17 3254 5923
Fax
Email
dr.kamaneh@goums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Marzieh Qaraaty
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Unit 1, The residential complex of Rose, 30th Sayyad, Martyr Sayyad shirazi Boulevard
City
Gorgan
Province
Golestan
Postal code
4917816337
Phone
+98 17 3254 3614
Fax
Email
gharaaty1387@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyed Abdolreza Kamaneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unit 5, The residential complex of Najafinejad, 6th Farhang, 9th Sayyad, Martyr Sayyad shirazi Boulevard
City
Gorgan
Province
Golestan
Postal code
4917976136
Phone
+98 17 3254 5923
Fax
Email
dr.kamaneh@goums.ac.ir
Web page address

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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...