Protocol summary

Study aim
To investigate the effect of Iranian medicine product on increasing the visual response to auditory stimuli in with autism
Design
This study is a randomized double-blind clinical trial study that will be conducted in parallel and with a ratio of 1:1. In this study, an experimental or interventional method will be used. In this way, we deeply examine the action and reactions between the factors that bring about change - the product of Iranian medicine - with the growth and expansion of the visual response of the autistic child. The case population is among the patients referred to Golhay Behesht Autism Spectrum Children's Rehabilitation Center in Qom who meet the inclusion criteria and do not use any other medication. Patients are randomly divided into two equal intervention and control groups.
Settings and conduct
The case population is among the patients referred to Golhay Behesht Autism Spectrum Children's Rehabilitation Center in Qom who meet the inclusion criteria and do not use any other medication. Patients are randomly divided into two equal intervention and control groups. Then the mothers of these children will be interviewed and consent to treatment with Iranian medicine products will be taken. Then, the temperament questionnaire is completed by interviewing the mothers and examining the children.
Participants/Inclusion and exclusion criteria
1) Children on the autism spectrum Center in Qom 2) Completion of informed 3) Do not take medicine 4) Age between 3 to 5 years
Intervention groups
Intervention group: 3 to 5 year old children with autism spectrum for whom traditional medicine products have been prescribed. Control group: Vedkan 3-5 years old with autism spectrum for whom placebo was prescribed.
Main outcome variables
The rate of increasing the visual response to auditory stimulation by prescribing a traditional medicine product

General information

Reason for update
Acronym
درمان گیاهی اوتیسم
IRCT registration information
IRCT registration number: IRCT20220628055306N1
Registration date: 2022-08-31, 1401/06/09
Registration timing: registered_while_recruiting

Last update: 2022-08-31, 1401/06/09
Update count: 0
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Mohsen Dayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3383 8303
Email address
najaf2@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Iranian medicine drug on increasing visual response to auditory stimuli in children with autism spectrum disorders; Double-blind clinical trial
Public title
The effect of Iranian medicine drug on increasing visual response to auditory stimuli in children with autism spectrum disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having autism Parental consent
Exclusion criteria:
taking medication
Age
From 3 years old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be used to assign people to intervention and control groups, and concealment will also be observed due to the use of this method. In this method, each person is assigned a unique code and it is pasted on the medicine packages, which will also help in the blinding process.
Blinding (investigator's opinion)
Double blinded
Blinding description
In conducting this study, the control group will be given a placebo and the center's therapists will be unaware of the allocation of the participants in the study to the intervention or control group. In this way, a unique code is assigned to each person and it is pasted on the medicine packages, and only the researcher is aware of the presence of each person in the Medakh group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
No.3, Dr Qarib Blvd, Dr Charmdooz Town
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.ARAKMU.REC.1400.254

Health conditions studied

1

Description of health condition studied
Treatment of autism with traditional medicine products
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
Measuring the rate of visual response to multiple auditory stimuli
Timepoint
The second week, the fourth week, the sixth week, the eighth week
Method of measurement
Record the visual response to the auditory stimulus

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 3 to 5 year old children with autism spectrum disorder who are prescribed 5 cc of traditional medicine product three times a day for 8 weeks, which is a combination of basil plant, betel nut and green cardamom fruit. Group members are evaluated every two weeks.
Category
Treatment - Drugs

2

Description
Control group: 3 to 5 year old children with autism, for whom 5 cc of traditional medicine product which is a combination of basil plant and green cardamom fruit is given three times a day for 8 weeks and each time to be Group members are evaluated every two weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golhai Behesht Qom Rehabilitation Center for Autistic Children
Full name of responsible person
Mahdi Alaee
Street address
No.3, Alley 19, St.Amir kabir
City
Qom
Province
Ghoum
Postal code
3713128569
Phone
+98 25 3650 1334
Fax
+98 25 3650 1335
Email
autism.qom97@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
No.3, Dr Gharib Blvd, Dr Charmdooz Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mohsen Dayani
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
NO.3, Dr Gharib Blvd, Dr Charmdooz Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
najaf2@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohsen Dayani
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3,Dr Gharib Blvd, Dr Charmdooz Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
najaf2@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohsen Dayani
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Dr Gharib Blvd, Dr Charmdooz Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
najaf2@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...