Objectives: This study aimed to determine the effect of Myrtle syrup on the chronic rhinosinusitis.
Design: This study is a randomized double blind clinical trial with negative control (placebo).
Setting and conduct: We will include patients with chronic rhinosinusitis who are enrolled in Masih daneshvari hospital that their diagnosis is confirmed with ENT specialist inspection and CT scan, They randomly placed in two groups.
Major Inclusion and exclusion criteria:
Inclusion criteria: patients older than 18 years with chronic rhinosinusitis who are enrolled in Masih Daneshvari hospital; Rhinosinusitis symptoms more than 3 month; no acute symptoms such as severe pain, pressure, fever or annoying purulent discharge; no previous use of antibiotics in past 7 day; no use of systemic corticosteroids in last three months.
Exclusion criteria: any serious side effects or allergies to medications that is attributable to trial drug; pregnancy; Intervention: 30 patients will receive Myrtle syrup 3% and 30 will receive placebo. Syrup (drug and placebo) is used 2 times daily for a month. 5 cc each half hour after a meal. In this study, patients are not denied of current treatments and therapies.
Main outcome measures (variables): Persian SNOT-22 questionnaire and VAS will completed before and after. Para nasal CT scan is performed too before and after treatment. After this time, the drug has been discontinued and relapsing symptoms after 4 weeks will be reviewed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020926465N1
Registration date:2016-03-03, 1394/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-03, 1394/12/13
Registrant information
Name
Mahboobeh Abrishamkar
Name of organization / entity
Traditional Medicine Faculty of Ardakan, Shahid Sadoughei University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 355252450
Email address
m_abrishamkar@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,shahid sadoughi university of medical sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Myrtus Communis L. (Myrtle) syrup in patients with chronic rhinosinusitis
Public title
Effect of Myrtus Communis L. (Myrtle) syrup in patients with chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic rhinosinusitis; over 18 years old; who come to the Masih Daneshvari hospital; Patients who suffer from rhinosinusitis symptoms for more than three months; Patients with chronic rhinosinusitis according to lund McKay scale criteria approved by an expert; Patients who would like to participate in voluntary and completed informed consent; Do not have sinus surgery; No sensitivity to common antibiotics or herbal remedies; Not pregnant or Plan to become pregnant; No immune deficiency (AIDS, diabetes or transplant); No acute respiratory disease in 7 days; Not have complicated acute sinusitis like an abscess; Not have acute symptoms such as severe pain or pressure, fever and purulent discharge; No ocular or brain complication of Sinusitis; No previous use of antibiotics in 7 days; Not use systemic corticosteroids in the last three months; Not any mental or psychological problem that cannot collaborate in projects.
Exclusion criteria: Any type of serious complication or sensitivity to prescription drugs in this study; Pregnancy.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was performed using a random numbers table.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in biomedical research/Shahid Sadoughi University of Medical Sciences and Health Se
Street address
Central department of Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Sq. Yazd
City
yazd
Postal code
8916978477
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
IR.SSU.REC.1394.148
Health conditions studied
1
Description of health condition studied
chronic rhinosinusitis
ICD-10 code
J32.8
ICD-10 code description
Other chronic sinusitis (chronic) involving more than one sinus but not pansinusitis
Primary outcomes
1
Description
SNOT-22
Timepoint
before/after (after1 month)
Method of measurement
fill questionnaire
Secondary outcomes
1
Description
VAS )visual analog scale)
Timepoint
before, after(after 1 month)
Method of measurement
Self-assessment questionnaire
Intervention groups
1
Description
Control group: placebo syrup/ 5 cc/ twice daily/30 days