Study of the therapeutic effects of AllergyCut as a herbal drug a in patients with allergic rhinitis.
Design
This investigation will be based on indicators, guidelines and forms of the World Association for Allergy (WAO).
The records of medical records will be compiled for patients whose allergy is confirmed.
Patients will be trained on the course of treatment, scheduling, drug intake, allergic factors, daily dosage forms, and absorption criteria during the course of treatment.
Settings and conduct
After diagnosis of allergic rhinitis in a study group by a specialist at the Aramesh Tehran Clinic, the patient will be provided with an explanation of the treatment and history of the study, the duration of the study and the services that will be received during this period.
Each month, after completing the necessary documentation by the patient, after delivery of the daily report and expert advice, the drug is delivered to the patient to complete the course of treatment.
After completing the course of treatment, further descriptions of the follow-up of the treatment process and the way of informing patients about the results of the study will be explained to them.
Participants/Inclusion and exclusion criteria
Those patients who have symptoms of rhinitis allergy will be included and who have symptoms of rhinitis allergy but will be reported as non-immunological by physician, will be excluded. Patients who do not provide sufficient information to counselors are excluded from the study.
Intervention groups
The test group is a group that is undergoing treatment with a own drug (nasal spray). The control group is a group of patients with allergic rhinitis without treatment with AllergyCut.
Main outcome variables
1. The Change of the amount of sneezing and cough
2. The Change in throat secretions
3. The change in nasal irradiation tears
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170705034915N2
Registration date:2019-02-06, 1397/11/17
Registration timing:retrospective
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Farid Semsarha
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8850 0280
Email address
fsemsarha@mimdaroo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Effectiveness of AllergyCut on Reducing the Severity and intensity of Disease in Allergic Rhinitis Patients
Public title
Investigation of AllergyCut therapeutic effect of Allergic Rhinitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Rhinitis after diagnosis by an immunologist or ENT physician
Male and female patient who has symptoms of allergic rhinitis at least one month per year.
A patient aged over 16 years old up to 60 years old who has the opportunity to complete the day care and has an effective relationship with the counselor.
A patient who does not have allergy to herbal medicines.
Exclusion criteria:
Patient with rhinitis without diagnosis of immunological basis.
Patients who do not want to start or continue treatment are not eligible for study.
Patients who provide incomplete data to the counselor.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of azad University-Research and science branch
Street address
Iran, Tehran, Ghods Town, Between South Falamak and Zarafshan, Iran Simay Avenue, Central Headquarters of the Ministry of Health Education, Unit A, Floor 13
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.IAU.SRB.REC.1397.031
Health conditions studied
1
Description of health condition studied
Rhinitis Allergy
ICD-10 code
J30.4
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Reduced Indicators Related to Rhinitis in Patients Consuming the Drugs
Timepoint
Drug intakes for 60 to 120 days
Method of measurement
Study of allergy-related rhinitis allergy indexes under the supervision of an immunologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with allergic rhinitis: Use of AllergyCut contains distilled plant product intended to remove symptoms of allergic rhinitis for 120 days with permissible dose every 6 hours 1 puff per nasal cavity.
Category
Treatment - Drugs
2
Description
Control group: Patients with allergic rhinitis: whiteout any treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arramesh Tehran clinic
Full name of responsible person
Masiha Hashemi- Farid Semsarha
Street address
No. 4, 4th Street, Ganbarzadeh Street, Shahid Beheshti Street