The effect of an anise-based product in Iranian traditional medicine, on the Treatment of patients with chronic rhinosinusitis (CRSsNP) , in comparison to fluticasone nasal spray
This Clinical Trial will evaluate the Effects of a herbal product based on Anise (Nasal Drop) on treatment of chronic Rhinosinusitis without polyps. 74 patients between 18 to 75 years old with chronic nasal complaints ( over 12 weeks ) referred to the ENT clinics after examination, diagnostic endoscopy and CT scan will diagnose as CRS and can enter to study. Patients eligible for inclusion in the study will divided by Block Randomization method into two groups. Treatment duration is one month in both groups. Patients in both groups evaluate by major and minor symptoms and signs of Rhinosinusitis and SNOT-22 questionnaire before and after intervention (day 0 and day 28).
Intervention Group will receive herbal nasal drop two times daily 3 drop in each nostril plus nasal irrigation for one month.
Control group will receive Fluticasone spray two puff in each nostril Two times daily plus nasal irrigation for one month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010516083N1
Registration date:2014-08-29, 1393/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-29, 1393/06/07
Registrant information
Name
Shima Vazifehkhah
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 22285292
Email address
shvazifehkhah@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2015-03-07, 1393/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an anise-based product in Iranian traditional medicine, on the Treatment of patients with chronic rhinosinusitis (CRSsNP) , in comparison to fluticasone nasal spray
Public title
The effect of an anise-based product in Iranian traditional medicine, on the Treatment of patients with chronic rhinosinusitis (CRSsNP) , in comparison to fluticasone nasal sprayMedicine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with presence of chronic rhinosinusitis symptoms for at least 12 weeks; positive CT result indicating the opacity and swelling of the sinus; Patients 18 to 75 years of both sexes; Treatment with systemic or nasal antibiotics or corticosteroids within 4 weeks before visit; Treatment wit h oral corticosteroids within the 30 days before visit; Treatment with topical corticosteroids within 15 days before visit.
Exclusion criteria: nasal and sinus surgery within the last 5 years; Presence of moderate to severe co-morbid asthma and mild asthma having exacerbation within 30 days prior to trial inclusion; Rhinitis medicamentosa (drug induced rhinitis); Known hypersensitivity to the medication or excipients; The signs and symptoms of bacterial sinusitis (fever ≥ 38.5, ocular complications, severe unilateral frontal headache or toothache); Acute seasonal allergy; other diseases which in the opinion of the investigator disqualifies the patient for trial enrolment(such as heart failure, kidney, lung and liver, drug addiction or alcoholism, neurological or psychiatric diseases, cancer, immunodeficiency) in the past 5 years; any side effect during treatment; Pregnancy; Breastfeeding
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
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
Vice-chancellor for research
Street address
Blv Keshavarz, Ghods St., 6th flour
City
Tehran
Postal code
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
130/2497/د/92
Health conditions studied
1
Description of health condition studied
Chronic sinusitis, unspecified
ICD-10 code
J32.9
ICD-10 code description
Sinusitis (chronic) NOS
Primary outcomes
1
Description
recovery
Timepoint
before intervention (day 0), and end of intervention (day 28)
Method of measurement
SNOT-22 Questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
day 7; day 28
Method of measurement
Ask the patient; The patient stated
Intervention groups
1
Description
Intervention: herbal nasal drop two times daily 3 drop in each nostril plus nasal irrigation for one month
Category
Treatment - Drugs
2
Description
Control: Fluticasone spray two puff in each nostril Two times daily plus nasal irrigation for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT Clinic in Emam Khomeini Hospital
Full name of responsible person
Dr Babak Saedi
Street address
Kshavarz Blv
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Dr Masud Yunesian
Street address
Keshavarz Blv. Corner of Ghods St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran 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
School of Traditional Medicine, Tehran University Of Medical Sciense
Full name of responsible person
Shima Vazifehkhah
Position
Md. Phd Student of TIM
Other areas of specialty/work
Street address
Vahdat Eslami St. corner of Behesht St.
City
Tehran
Postal code
Phone
+98 21 5558 0386
Fax
Email
sh-vazifehkhah@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Saedi
Position
Associated Professor of Tehran University of Medical Sciences, Otolaryngologist
Other areas of specialty/work
Street address
Tehran, Keshavarz Blvd, Imam Khomeini Hospital
City
Thran
Postal code
Phone
+98 21 6658 1628
Fax
Email
saedi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine of Tehran University of Medical Sciences
Full name of responsible person
Shima Vazifehkhah
Position
MD. Phd student in Traditional Iranian Medicine
Other areas of specialty/work
Street address
City
Vhdat Eslami St. corner of Behesht St.
Postal code
Phone
00
Fax
Email
sh-vazifehkhah@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)