This study is a randomized, open-label clinical trial; in order to evaluate the effect of manual acupuncture along with conventional therapies on the treatment of allergic rhinitis on 54 patients with allergic rhinitis referred to the ENT clinic of Kashani and Alzahra hospitals in Isfahan will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria include having allergic rhinitis, having positive skin allergy test determined by Skin Prick Test, and declaring satisfaction to participate in the study. Exclusion criteria include having any previous rhinoplasty surgery, nasal anatomical abnormalities such as nasal polyps or septal abnormalities, a refractory asthma, a long-term use of corticosteroids, tuberculosis, diabetes, and any other chronic systemic diseases as well as being suspicious for malignancy.
Intervention groups
In the first group, in addition to the routine treatment, patients will be treated with manual acupuncture twice a week for three weeks. In the second group, only conventional treatment will be performed for patients.
Main outcome variables
Runny nose; Sneezing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N8
Registration date:2020-10-18, 1399/07/27
Registration timing:retrospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Manual Acupuncture along with Conventional Therapies on the Treatment of Allergic Rhinitis
Public title
The Effect of Manual Acupuncture on the Treatment of Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Allergic Rhinitis
Positive skin allergy test determined by Skin Prick Test (SPT)
Declaring satisfaction to participate in the study
Exclusion criteria:
Having any previous rhinoplasty surgery
Having nasal anatomical abnormalities such as nasal polyps or septal abnormalities
Having a refractory asthma
Having a long-term use of corticosteroids
Having tuberculosis
Having diabetes, and any other chronic systemic diseases as well as being suspicious for malignancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
First, eligible patients will be randomly selected. Then, random numbers are generated and divided into two groups using computer random allocation software. A number will be randomly assigned to each patient; that this number indicates what group should be patient assigned.
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.MUI.MED.REC.1398.716
Health conditions studied
1
Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30.9
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Runny nose
Timepoint
Based on Visual analog scale
Method of measurement
Before, 2 and 6 weeks after treatment
2
Description
Sneezing
Timepoint
Before, 2 and 6 weeks after treatment
Method of measurement
Based on Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients, in addition to conventional treatment, they will be treated with manual acupuncture twice a week for three weeks. Before starting the acupuncture treatment, patients will be examined to specify traditional Chinese medicine pattern recognition. Basic points for acupuncture including Tinghui (GB2, depth 0.5 cun), Tinggong (SI19, depth: 0.5cun), Ermen (TE21, depth 0.5cun), and Yifeng (TE17, depth 0,5cun ) will be selected according to the World Health Organization guidelines. Other points are selected according to guidelines on Chinese medicine diagnosis. A maximum of five points of the most active points will be selected by point selector devise. patients are placed in the sitting position and the acupoint area will be disinfected twice with iodine. The acupuncturist places his/her left index finger immediately above the acupoint, holds the needle between his/her right thumb and index finger, and quickly pierces the skin of the patient.
Category
Treatment - Other
2
Description
Intervention group: For patients, only the conventional treatment is performed. Conventional treatment for allergic rhinitis will include the use of 10 mg Cetirizine tablets daily, and the use of normal saline nasal spray to rinse the nose, as well as the daily Beconase spray inside each nose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ear Nose and Throat Clinic of Al-Zahra Hospital
Full name of responsible person
Sayed Mostafa Hashemi
Street address
Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8179964167
Phone
+98 31 3651 3337
Email
mostafa_hashemi@med.mui.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Ear Nose and Throat Clinic of Al-Zahra Hospital
Full name of responsible person
Sayed Mostafa Hashemi
Street address
Kashani Street
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
mostafa_hashemi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Mostafa Hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani Street
City
Isfahan
Province
Isfehan
Postal code
8183983414
Phone
+98 31 3233 0091
Email
mostafa_hashemi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Mostafa Hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kashani Street
City
Isfahan
Province
Isfehan
Postal code
8183983414
Phone
+98 31 3233 0091
Email
mostafa_hashemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhang Mokhtarinejad
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ordibehesht Street
City
Isfahan
Province
Isfehan
Postal code
8179960036
Phone
+98 31 3268 5137
Email
f.mokhtarinezhad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD