Evaluation of the Effect of Matricaria Chamomilla on Quality of Life in Patients with Chronic Rhinosinusitis Referred to Amiralmounin Hospital in Rasht
Determination of the effect of matricaria chamomilla on quality of life in patients with chronic rhinosinusitis referred to Amiralmounin Hospital in Rasht
Design
In this study, 74 patients with chronic rhinosinusitis having inclusion criteria who were referred to Amiralmomenin Hospital in Rasht are selected. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
In this study, 74 patients referring to Amiralmounin Hospital in Rasht are evaluated by blindfolded randomized clinical trial method. Sampling is performed by Balanced Block Randomization method. The data collection tool is information collection (questionnaire) that includs demographic data of patients, SNOT-22 questionnaire before and after treatment and possible complications. First examination of the patients will be done one week later and a second examination two weeks and a third examination three weeks after the start of treatment by the otolaryngologist, without knowing the patients are in which group, and the effect of treatment and possible side effects of drug use will be recorded.
Participants/Inclusion and exclusion criteria
including criteria:age obove 18; having a minimum reading and writing literacy; affected by chronic rhinosinusitis according to the diagnosis of otolaryngologist;
Exclusion Criteria: Pregnancy; History of sinus and nasal surgery; Usage corticosteroid drugs continuously and daily; Immunocompromised Disease; Nasal polyps; Lund-Mackay scores above 14 in sinus CT scan; Affected by chronic rhinosinusitis according to the diagnosis of otolaryngologist;
Intervention groups
A group receiving chamomile drop
The group receiving the placebo (drops of sesame seed oil)
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080831001138N27
Registration date:2018-05-09, 1397/02/19
Registration timing:registered_while_recruiting
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-22, 1396/12/03
Expected recruitment end date
2018-08-20, 1397/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Matricaria Chamomilla on Quality of Life in Patients with Chronic Rhinosinusitis Referred to Amiralmounin Hospital in Rasht
Public title
Effect of Matricaria Chamomilla on Quality of Life in Patients with Chronic Rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Having at least reading and writing skills
Having chronic rhinosinusitis according to the diagnosis of ENT
Exclusion criteria:
Pregnancy
History of sinus and nasal surgery
Usage of corticosteroid drugs continuously and daily
History of nasal polyp
Lund-Mackay scores above 14 in sinus CT
Rhinosinusitis Chronic exacerbation requires antibiotics
History of any sensitivity to chamomile or its compounds
Usage of drugs such as ciclosporin, aspirin, warfarin and heparin
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this way at first, before the start of the study, the Random Allocation software gives a list of random numbers that is evenly divided into two groups A and B to a third party, each of them in separate closed envelopes according to the list. If the patient is referred to and qualified, one of the envelopes is given to the patient according to the number and after filling the forms, the envelope is opened and the patient is placed in one of the groups and receives the corresponding medication. Patients will not inform about the received medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to maintain blindfolded of the study, both patients and researchers associated with patients will be unaware of the patient's drug intake (in the clinic, one researcher will distribute and record the drug to the patient, and the other researcher will evaluate the patients. Medications will look quite similar in shape, color and size
Placebo
Used
Assignment
Parallel
Other design features
The clinical trial has two groups of cases and controls
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
vice-chancellor for Research Building, opposite of Sepah Bank,Shahid Beheshti Blvd
City
Rasht
Province
Guilan
Postal code
4139637459
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.GUMS.REC.1396.513
Health conditions studied
1
Description of health condition studied
Chronic rhinosinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
Quality of life
Timepoint
Before the treatment, the first week, second week, third week
Method of measurement
Information obtained from the Sino-Nasal Outcome Test (SNOT-22) Questionnaire and biographies
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, chamomile extract was prepared by maceration method. Patients use 3 drops of the extract in each nostril after washing each nostril with 10 cc normal saline three times a day
Category
Treatment - Drugs
2
Description
Control group: washes the nose with 10 cc normal saline in each nostril three times a day then uses sesame seed oil as a placebo and three drops per nostril. All patients will be taught how to properly use drug and nasal washing