Improving the delivery and treatment of anxiety symptoms in ADHD children and increasing satisfaction levels.
Design
Randomized clinical trial
Settings and conduct
Children Psychiatric Clinic of Ibn Sina Hospital in Mashhad.
Referring children who are interviewed and diagnosed by the pediatric psychiatric specialist are included in the study.After obtaining informed consent from their legal guardians, they are randomly divided into two groups of case and control according to the random numbers table. RCMA questionnaire to assess the level of anxiety in all patients.The case group, in addition to the standard ADHD treatment, is treated with 10 mg capsules of Whitney Sinnifera root and is added to the standard treatment of ADHD treatment in the oral administration of placebo capsule.All children in weeks3 and 6 again tested RCMA and the ADHD scoring scale was also filled by a psychiatrist's assistant during the weeks mentioned.
Participants/Inclusion and exclusion criteria
28 children with attention deficit and hyperactivity disorder, who have shown anxiety symptoms Their age ranges from 7 to 12 years old and they have been receiving ADHD treatment for 3 months, and informed consent has been completed by legal guardians. Exit criteria include the patient's unwillingness to continue to participate in a research project for systemic and psychiatric illnesses.
Intervention groups
Intervention group:Withania somnifera capsule is given orally at a dose of 10 mg once a day for 6 weeks.
treatment-drugs
Control group: A placebo capsule similar to that of Withania Somnifra is given orally at a dose of 10 mg once a day for 6 weeks.
Main outcome variables
Investigating the effect of Withania somnifera on symptoms of anxiety in children with ADHD.
Evaluation of the effect of withania somnifira on the ADHD symptoms .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040567N1
Registration date:2018-11-10, 1397/08/19
Registration timing:retrospective
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
NARGES HOSSEINI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3700 2310
Email address
hoseinin941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-05, 1397/01/16
Expected recruitment end date
2018-10-19, 1397/07/27
Actual recruitment start date
2018-04-05, 1397/01/16
Actual recruitment end date
2018-10-19, 1397/07/27
Trial completion date
2018-10-19, 1397/07/27
Scientific title
Effect of Withania somnifera Root Extract on Anxiety Symptoms in Children with Attention deficite and Hyperactivity Disorder
Public title
The effect of Withania somnifera on anxiety symptoms in children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ADHD based on DSM-5 criteria
aged 7-12 years
Complete consent form by parent or guardian
Normal IQ
Symptoms of simultaneous anxiety
Exclusion criteria:
The patient's unwillingness to participating in the research project
Systemic disease
Interventional psychiatric illness
intellectual disability
Age
From 7 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
28
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected through available sampling. They are randomly divided into two groups of case and control according to the random numbers table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is double blind: the form of drug and placebo is the same, and the evaluator, the patient and the analyst are not aware of what treatment they are using, and drug intervention is identified by the pharmacist in sealed envelopes with a numeric code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Ghoreishi Department, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175845643
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
ir.mums.fm.rec.1396.214
Health conditions studied
1
Description of health condition studied
Attention- Deficit Hyperactivity Disorders
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Anxiety symptoms in children with ADHD
Timepoint
At the beginning of STUDY and the week 3 and 6
Method of measurement
Child Anxiety Test based on the revised child anxiety scale(RCMA)
2
Description
Symptoms of ADHD
Timepoint
Weeks 3 and 6
Method of measurement
ADHD rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Withania somnifera capsule is orally administered at a dose of 10 mg once daily for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: The placebo capsule is similar to the Withania somnifera capsule orally at a dose of 10 mg once a day for 6 weeks.