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Elucidation of sinusitis based on Traditional Persian Medicine (TPM) and comparison of the TPM therapeutic protocol efficacy on chronic sinusitis with classic treatment: Mixed Methods

Protocol summary

Summary
Objective: to determine the effectiveness of the treatment protocol based on traditional medicine on chronic sinusitis, compared to classical drug therapy. Study design: non-randomized, not-blinded, non placebo-controlled, multi-center, phase I trial study. Trial method includes: Main inclusion criteria (nasal obstruction or congestion, anterior or posterior nasal discharge, facial pain or pressure, and reduction or loss of smell). Main exclusion criteria (acute bacterial infection of the respiratory tract, anatomical obstructions requiring surgery, allergies or other contraindications to the drug combination in patients, pregnancy, immune deficiency or Hypertension). Sample size: 52 patient. Intervention or interventions studied: Endoscopy and CT scan diagnosis - treatment with therapeutic package. Intervention time: 8 to 12 weeks. Primary outcome or consequences of the study: a reduction or improvement in the symptoms of patients on the standard scale evaluation (SNOT22)

General information

Acronym
TPM: Traditional Persian Medicine, EP3OS: European Position Paper on Rhinosinusitis and Nasal Polyp
IRCT registration information
IRCT registration number: IRCT2015112425217N1
Registration date: 2016-01-31, 1394/11/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Mohammad Reza Mehri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3343 5122
Email address
mehrimr1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Elucidation of sinusitis based on Traditional Persian Medicine (TPM) and comparison of the TPM therapeutic protocol efficacy on chronic sinusitis with classic treatment: Mixed Methods
Public title
Effect of a herbal medicine combinations in the treatment of chronic sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Two criteria of the main criteria (including: nasal obstruction or congestion; anterior or posterior nasal secretion; facial pain or pressure; and reduction or loss of smell) or one major criterion and two minor criteria (including dental pain; cough; pain; pressure or fullness feel in ears; fatigue; headache or halitosis) for more than 12 weeks during the past 12 months. Exclusion criteria: Chronic sinusitis along with acute bacterial infections of the respiratory tract; Chronic sinusitis along with anatomical obstructions requiring surgery; Sensitivity or contraindication to the drug components; Pregnancy; Immunodeficiency; The presence of high blood pressure (hypertension history or blood pressure on admission greater than 140/90 mm Hg)
Age
From 18 years old to 49 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical Sciences, Central office of Mashhad University of Medical Sciences, Daneshgah Ave., Mashhad, Iran
City
Mashhad
Postal code
91388-13944
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
IR.MUMS.REC.1394.504

Health conditions studied

1

Description of health condition studied
Chronic sinusitis
ICD-10 code
J32
ICD-10 code description
J32Chronic sinusitis Incl.: abscess, empyema, infection, suppuration (chronic) of sinus (accessory)(nasal

Primary outcomes

1

Description
Symptoms of chronic sinusitis
Timepoint
Baseline and sixth, eighth and twelfth week after intervention
Method of measurement
SNOT22 Questionnaire

Secondary outcomes

1

Description
Paranasal sinuses status
Timepoint
Before the intervention and twelve weeks after beginning intervention
Method of measurement
Lund-Mackey Score

2

Description
Symptoms of cold Coryza (Zokam) and Catarrh (Nazlah)
Timepoint
Before the intervention and twelve weeks after intervention beginning
Method of measurement
cold Coryza (Zokam) and Catarrh (Nazlah) questionnaire

Intervention groups

1

Description
Intervention group: Oral drug: Marjoram and licorice herbal tea, dose: 5 grams of pack contains 3 grams of leaves of marjoram and 2 grams of licorice root, every 8 hours, the duration of treatment (consumption): 8 weeks; If there is no improvement in symptoms for up to 12 weeks will continue. How to use: patient should be infuse the contents of each packet with 200 ml of boiling water in the pot for 20 minutes and after clearing, to be drink slowly at a temperature close lukewarm to hot , divided by maintaining an hour away from food, . Local drug: Lavender oil on base of olive oil, dosage: 3-2 drops once a day (at night), the duration of treatment (consumption): 8 weeks; if there is no improvement in symptoms for up to 12 weeks will continue. Education: patients of this group on the basis of written instructions that will be placed at their disposal, will be avoided from harmful foods for cold and catarrh (such as yogurt, buttermilk, cheese, dough bread , bananas, vinegar, ...).
Category
Treatment - Drugs

2

Description
Control group: Prescription drugs include: Inhaled corticosteroid (Fluxinase), at a rate of 2 inhalations per day; along with daily nose irrigation with normal saline in the morning and evening. If there is no improvement, a systemic steroids will be administrated (prednisone tablets 1 mg / kg; that will be tapered within a short time). If there is evidence of purulent sinusitis, antibiotic treatment with azithromycin capsules of 250 mg daily for 4 weeks will be added to the treatment protocol.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Special clinic for ear, nose and throat diseases, Imam Reza (AS) Hospital
Full name of responsible person
Dr. Mehdi Bakhshaee , Ear, nose and throat specialist, Associate professor
Street address
Special clinic for ear, nose and throat diseases, Imam Reza Sq, Ibn Sina St., Mashhad.
City
Mashhad

2

Recruitment center
Name of recruitment center
Special clinic for Persian Traditional Medicine, Imam Reza (AS) Hospital
Full name of responsible person
Dr. Majid Anushiravani, Persian Traditional Medicine Specialist, Assistant Professor
Street address
Special clinic for Persian Traditional Medicine, Imam Reza Sq, Ibn Sina St., Mashhad.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi, Research Vice Chancellor
Street address
Vice Chancellery for Research of Mashhad University of Medical Sciences, Mashhad University of Medical Sciences, Golestan Crossroads, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research of Mashhad 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
Mashhad University of Medical Sciences, Faculty of Traditional and Complementary Medicine
Full name of responsible person
Dr. Mohammad Reza Mehri
Position
Persian Traditional Medicine Student
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, Razi sharghi Ave., 10 Dey Sq., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51385521889
Fax
+98 51 3853 5980
Email
Mehrimr1@mums.ac.ir; Drmrmehri@yahoo.com
Web page address
http://tim.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Traditional and Complementary Medicine
Full name of responsible person
Dr. Majid Anushiravani
Position
Persian Traditional Medicine Specialist, Assistant Professor
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, Razi sharghi Ave., 10 Dey Sq., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51385521889
Fax
+98 51 3853 5980
Email
dr.anushiravani@gmail.com
Web page address
http://tim.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Traditional and Complementary Medicine
Full name of responsible person
Dr. Mohammad Reza Mehri
Position
Persian Traditional Medicine Student
Other areas of specialty/work
Street address
Faculty of Traditional and Complementary Medicine, Razi sharghi Ave., 10 Dey Sq., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
Mehrimr1@mums.ac.ir; Drmrmehri@yahoo.com
Web page address
http://tim.mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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