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Effects of Botulinium Toxin -A in perennial allergic rhinitis patients resistant to conventional treatments

Protocol summary

Summary
The main goal of this study was to examine the effects of Botulinium Toxin-A in relieving symptoms of patients with perennial allergic rhinitis, who have been treated with antihistamines and corticosteroids for the past three years, but no recovery obtained. 40 male and female patients, between ages 20-40 years from clinics of (Pasargad; Karimkhan; Saee and the University of Social Welfare and Rehabilitation Sciences), based on inclusion ( chronic allergic rhinitis for the past three years ;Have not been cured with above mentioned medications ) and exclusion criteria (chronic sinusitis; asthma and or having other diseases), were selected. Prior to interventions, research goals discussed, informed consents obtained voluntarily and then patients got divided randomly into two intervention (n=20) and control (n=20) groups. The intervention group received 100 IU of Botulinium Toxin-A, mixed with nasal tampons(10 cm) and control group with the same method, but tampons mixed with Normal Saline which remained in their intranasal cavities for 30 minutes. Both groups were not aware of their type of treatments. Symptoms assessed via a pre-designed, closed- questionnaire charts for itching (eyes, ears and nose); sneeze and rhinorrhea, which all graded from intervals of no symptoms (0) to sever (10). Scores collected in both groups for analysis in pre and post- intervention periods of (1, 3, 6 and 12 weeks) for analysis.

General information

Acronym
BTX-A=Botulinium Toxin type A
IRCT registration information
IRCT registration number: IRCT201206079963N1
Registration date: 2012-08-03, 1391/05/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-03, 1391/05/13
Registrant information
Name
Hashem Shemshadi
Name of organization / entity
Unversity of Social Welfare and Rehabilitation Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0140
Email address
shemshadi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Scienses
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2012-08-02, 1391/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Botulinium Toxin -A in perennial allergic rhinitis patients resistant to conventional treatments
Public title
Effects of Botulinium Toxin-A in perennial allergic rhinitis patients resistant to conventional treatments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Males and females age between 20-40; Having perennial (minimum of three years) allergic rhinitis who have received conventional treatments with no results; Having a minimum educational level ( high school diploma); Being stable in emotional,physical and other health status suitable for entering study ; Informed consent to be understood and be signed voluntarily. Exclusion criteria: Ages below 20 or above 40 years; History of chronic sinusitis,asthma and or other systemic disoredrs ; History of using Botulinium Toxin type -A for any reason; Rejecting to accept and or signing the informed consent.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University Ethics Committee
Street address
Evin-Daneshjoo Blvd.-Koodakyar St.
City
Tehran
Postal code
1985713834
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91/801/1/6020

Health conditions studied

1

Description of health condition studied
perennial allergic rhinitis
ICD-10 code
J30.3
ICD-10 code description
other allergic rhinitis/perennial allergic rhinitis

Primary outcomes

1

Description
relieving symptoms of perennial allergic rhinitis such as itching(eyes,ears and nose),sneez and rhinorrhea after intervention
Timepoint
1,3,6 and 12 weeks post intervention
Method of measurement
smyptoms chart converting qualitative symptoms of itching(eyes,ears,nose),sneez and rhinorrhea to quantitative from no symptoms(0) to worst symptoms(10) .Scorings are collected in both groups for final statistical analysis.

Secondary outcomes

1

Description
Observing any drug`s side effects in intervetion group.
Timepoint
1,3,6 and 12 weeks post intervention
Method of measurement
Recording any kinds of side effects in pre-designed chart related to each patient from degrees of not having (0) to sever degrees of side effects (10)

Intervention groups

1

Description
Intervention group; Treated with 100 IU Botulinium Toxin type A admixed with 10cm nasal tampons which remained in their nasal cavities for 30 minutes.
Category
Treatment - Drugs

2

Description
Control group; Treated with the same method as intervention group ,but nasal tampons mixed with Normal Saline which remained in their intranasal cavities for 30 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr.Hashem Shemshadi
Street address
Evin-Daneshjoo Blvd.,Koodakyar St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Dr.hashem Shemshadi
Street address
Evin-Daneshjoo Blvd.Koodakyar St.
City
Tehran
Grant name
معاونت تحقیقات و فنا وری
Grant code / Reference number
91
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr.Hashem Shemshadi
Position
Associate professor/Plastic and Reconstructive Surgeon
Other areas of specialty/work
Street address
Evin-Daneshjoo Blvd. Koodakyar St.
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0140
Fax
+98 21 2218 0140
Email
shemshadi@uswr.ac.irshemshadii@gmail.comshemshadii@hotmail.com
Web page address
www.uswr.ac.ir/shemshadi

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation sciences
Full name of responsible person
Dr.Hashem Shemshadi
Position
Associate Professor/Plastic and Reconstructive Surgeon
Other areas of specialty/work
Street address
Evin-Daneshjoo Blvd.-Koodakyar st.
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0140
Fax
+98 21 2218 0140
Email
shemshadi@uswr.ac.ir shemshadii@gmail.com shemshadii@hotmail.com
Web page address
www.uswr.ac.ir/shemshadi

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr.Hashem Shemshadi
Position
Associate Professor/Plastic and reconstructive Surgeon
Other areas of specialty/work
Street address
Evin-Daneshjoo Blvd.-Koodakyar St.
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0140
Fax
+98 21 2218 0140
Email
shemshadi@uswr.ac.irshemshadii@gmail.comshemshadii@hotmail.com
Web page address
www.uswr.ac.ir/shemshadi

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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