1) Objective: Patients with sinusitis in many parts of the world, especially in cold regions there. There is no specific medication for treatment. Antibiotics used in treatment only. A drug with the least side effects and quite naturally we decided to treat this condition with very low cost and ease of use with the lack of treatment resistance in our body.
2) Design: Drop Damperly natural medicines derived from medicinal herbs such as black seed, rosemary and olive oil, which has antibacterial and antimicrobial activity and causes dilation of the arteries, congestion, sputum collection and disposal of infection and eventually drain the sinuses of pathogens is causing.
3) How to do: to treat patients randomly selected from patients referred to health centers and to get informed consent to be enrolled. This Damperly loved ones or drop or get it as a completely randomized placebo for 30 days and one day they use only a drop in the nose.
4) Participants: Study inclusion criteria will be as follows: 1. the patient is not under 7 years. 2. there is no history of certain diseases. 3. The patient is not pregnant. 4. The patient is not breast feeding. Exclusion criteria were studies will be as follows: 1. self-satisfaction. 2-allergy herbal medicine Sign Dameprly sensitive type.
5)routine treatment of sinusitis, including antibiotic Co-amoxiclav (if the sensitivity of Cefixime), serum washing (2-3 times a day) and Fluticasone spray is carried out.
6) The main outcome variables: After two weeks of receiving medications based on major and minor symptoms of sinusitis was examined and trend analysis of the notes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122131510N1
Registration date:2017-01-16, 1395/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-16, 1395/10/27
Registrant information
Name
Mahmud Khorushy
Name of organization / entity
iranian academic center for education, culture and research-Ardabil Branch
Country
Iran (Islamic Republic of)
Phone
+98 45 3374 9503
Email address
sec.ar@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian Academic Center for Education, Culture and Research, Ardabil branch
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Damprly herbal drops for the treatment of sinusitis patients with acute sinusitis
Public title
The effect of Damperli herbal drop on Sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Study inclusion criteria will be as follows: 1. the patient is not under 7 years. 2.there is no history of certain diseases. 3. The patient is not pregnant. 4. The patient is not breast feeding.
Exclusion criteria were studies will be as follows: 1- self-satisfaction. 2-allergy Damperly herbal drops sensitive type.
Age
From 7 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences and Health Services
Street address
Ardabil University of Medical Sciences, Daneshgah street.
Controls: placebo drops of distilled water or NaCl which will be used as a drop Damprly consumed.routine treatment of sinusitis, including antibiotic Co-amoxiclav (if the sensitivity of Cefixime), serum washing (2-3 times a day) and Fluticasone spray is carried out.
Category
Placebo
2
Description
Invention: drop Damprly be used.
routine treatment of sinusitis, including antibiotic Co-amoxiclav (if the sensitivity of Cefixime), serum washing (2-3 times a day) and Fluticasone spray is carried out.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabalan hospital
Full name of responsible person
Dr. Rauf Molla Javadi
Street address
Vahdat sq.
City
Ardabil
2
Recruitment center
Name of recruitment center
Fatemi hospital
Full name of responsible person
Dr. Soureh Allaf Akbari
Street address
Sharyati sq.
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
iranian academic center for education, culture and research, ardabil branch
Full name of responsible person
Dr. Ramez Nasiri Saleh
Street address
Shafa Sq., Karshenasan
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
iranian academic center for education, culture and research, ardabil branch
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
S. W. A. Co.
Full name of responsible person
Mahmud Khorushy
Position
Chairman of the Board
Other areas of specialty/work
Street address
S. W. A. Co., Shafa Sq., Karshenasan
City
Ardabil
Postal code
Phone
+98 45337495038
Fax
Email
azhyaneh.co@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Rauf Mollajavadi
Position
ENT specialist
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Daneshgah St.
City
Ardebil
Postal code
Phone
+98 45 3374 9503
Fax
Email
azhyaneh.co@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Academic Center for Education, Culture and Research, Ardabil branch
Full name of responsible person
Mahmud Khorushy
Position
member
Other areas of specialty/work
Street address
Shafa sq., Shahrak Karshenasan
City
Ardabil
Postal code
5613643151
Phone
+98 45337495038
Fax
+98 45 3374 9508
Email
azhyaneh.co@gmail.com
Web page address
www.jdard.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)