Evaluation the efficacy of topical non-liposomal amphotericin B in the treatment of chronic sinusitis
Design
Double-blind Clinical trial with control group and parallel , phase 2-3 on 80 patients, by simple randomization method using closed door envelope
Settings and conduct
This double blind randomized clinical trial (participants and analyzers would blinded) is performed in the ENT ward of Ghaem Hospital in Mashhad on 80 patients with chronic sinusitis who were candidates for endoscopic surgery according to the doctor's diagnosis. Eligible patients are divided into control and intervention groups after obtaining consent. In the intervention group, in addition to routine treatment with amphotericin B solution, and in the control group with normal saline for nasal lavage twice a day for one month will be used and finally the results would be entered into SPSS software and analyzed.
Participants/Inclusion and exclusion criteria
Patients with chronic sinusitis who, according to the physician, were candidates for endoscopic surgery and would fully satisfied entering the project and had no history of surgery or use of antifungal antibiotics in the past month and did not have underlying diseases such as granulomatosis or kidney disease.
Intervention groups
In the intervention group, 40 patients with chronic sinusitis in addition to routine treatment would use amphotericin B solution for nasal lavage twice a day for a month and in the control group of 40 patients in addition to routine treatment would Use normal saline solution twice a day for a month to rinse the nose.
Main outcome variables
Clinical status of the patient based on Land Criteria and status of polyps based on endoscopic findings before and after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N42
Registration date:2021-09-27, 1400/07/05
Registration timing:prospective
Last update:2021-09-27, 1400/07/05
Update count:0
Registration date
2021-09-27, 1400/07/05
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of non-liposomal amphotericin B in the treatment of chronic sinusitis
Public title
The effect of amphotericin B on sinusitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic sinusitis with polyposis
Candidate for sinus endoscopy surgery
Conscious consent to participate in the study
Exclusion criteria:
Co-occurrence of systemic diseases such as diabetes, chronic renal failure, malignancies, cystic fibrosis, or granulomatous diseases
Being pregnant
Breastfeeding
Have no history of surgery in the last month
Have no history of taking antifungal antibiotics in the past month
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects and those evaluating the outcome will be unaware of the intervention and control groups
Placebo
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 Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2019-08-13, 1398/05/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.448
Health conditions studied
1
Description of health condition studied
Chronic sinusitis and polyposis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified
Primary outcomes
1
Description
Clinical status
Timepoint
At the end of 4 weeks
Method of measurement
Land Score
2
Description
Recurrence of polyps
Timepoint
At the end of 4 weeks
Method of measurement
Based on endoscopic criteria of the nose
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, 40 patients, in addition to routine treatment, use amphotericin B solution for rinsing the nose twice a day for a month.
Category
Treatment - Other
2
Description
Control group: In this group, in addition to routine treatment, 40 patients use normal saline solution for rinsing the nose twice a day for a month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Nazanin Yousefi
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
Yousefin961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 -91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Majidi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
majidimr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Majidi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
majidimr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Majidi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
majidimr@mums.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