Effectiveness of Sweet almond syrup, Iranian Traditional Medicine product, compared with methylphenidate for Attention-Deficit/Hyperactivity Disorder in children: triple-blind randomized Clinical trial
The purpose of this study is to evaluate the effect of Sweet almond syrup for Attention-Deficit/Hyperactivity Disorder in children. The study is a randomized, triple-blind and single-center which will be carried out on 50 patients with combined subtype ADHD referred to Ziaeian Hospital. The study will be conducted on children with 6 to 14 years, Has been diagnosed by a child psychiatrist and not received any other treatment yet and has no other mental or physical illness at the same time and will be excluded if side effects and drug intolerance occurs. Method: with simple randomization, Patients will be divided into 2 groups: Intervention Group (sweet almond syrup and an ineffective tablet as placebo) and Control Group (Ritalin and an ineffective syrup as placebo). Patients will be treated for 8 weeks and will be visited in the first day and then weeks 2, 4, 6 and 8 after starting the drug and the response to treatment and possible side effects are examined by the relevant examination and questionnaire.
General information
Acronym
Attention-Deficit/Hyperactivity Disorder : ADHD
IRCT registration information
IRCT registration number:IRCT2015050922165N1
Registration date:2015-07-14, 1394/04/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-14, 1394/04/23
Registrant information
Name
Monireh Sadat Motaharifard
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3333 6823
Email address
m-motaharifard@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran university of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Sweet almond syrup, Iranian Traditional Medicine product, compared with methylphenidate for Attention-Deficit/Hyperactivity Disorder in children: triple-blind randomized Clinical trial
Public title
Effect of Sweet almond on ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 6 to 14 years; Combined subtype ADHD diagnosis by a psychiatrist; Obtain written informed consent from each patient's parent or guardian; No mental retardation (I.Q.>70); Non use of other Complementary and Alternative Medicine methods; No any significant chronic medical condition including cardiovascular disease, GI disorders, seizures; No other psychiatric disorder such as schizophrenia; No organic brain disorder; No clear developmental disorders and Malnutrition; no recent treatment with psychotherapic drugs; Not clinically current abuse or dependence on drugs within 6 months; New diagnoses of disorder and No other drug use; Not required behavior Therapy; No sensitivity to sweet almond and its products; Non-concurrent use of other products containing almonds (Nuts, nougat)
Exclusion criteria: Symptoms of sensitivity to sweet almond; Intolerance sweet almond syrup; Complications increase in moisture in the body; Dissatisfaction of parents or patient; The risk of other mental illness that requires treatment during the study
Age
From 6 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Keshavarz Ave., Tehran