Studying the effect of nanocurcumin as an adjunctive treatment to methylphenidate for attention deficit/hyperactivity disorder
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
This study will be performed on patients attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: ADHD diagnosis based on DSM5 - Individuals between 6-17 years old. Exclusion criteria: Presence of severe medical illness, neurological problems and problems requiring surgery - Presence of any concomitant psychiatric disorder that requires treatment with psychiatric drugs except ODD - Consumption neuroleptic medication in the last 6 months - Weight less than 13.5 kg - Mental retardation - Uncontrolled seizure disorder - Systolic blood pressure above 125 mm Hg or Resting pulse rate less than 60 beats per minute or above 115 beats per minute - Using any medicine or supplement for the treatment of ADHD
Intervention groups
Control group: Participants receive methylphenidate at a dose adjusted according to body weight and clinical response (0.3–1.5 mg/kg/day). During the first week, they take one tablet daily (half in the morning and half at noon); in the second week, one tablet in the morning and one at noon; and from the third week, if their weight exceeds 30 kg, three tablets daily—morning, noon, and afternoon (4 p.m.). They also receive a placebo twice daily. Intervention group: Participants receive the same methylphenidate regimen but additionally takes 20 mg of nanocurcumin twice daily. All medications are administered orally.
Main outcome variables
Severity of ADHD symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N168
Registration date:2026-02-11, 1404/11/22
Registration timing:prospective
Last update:2026-02-11, 1404/11/22
Update count:0
Registration date
2026-02-11, 1404/11/22
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2028-02-20, 1406/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Nanocurcumin adjunct to methylphenidate for attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled trial
Public title
Nanocurcumin for the treatment of attention-deficit/hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ADHD diagnosis based on DSM5
Individuals between 6-17 years old
Exclusion criteria:
Presence of severe medical illness, neurological problems and problems requiring surgery
Presence of any concomitant psychiatric disorder that requires treatment with psychiatric drugs except ODD
Consumption neuroleptic medication in the last 6 months
Weight less than 13.5 kg
Mental retardation
Uncontrolled seizure disorder
Systolic blood pressure above 125 mm Hg or Resting pulse rate less than 60 beats per minute or above 115 beats per minute
Using any medicine or supplement for the treatment of ADHD
Age
From 6 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups).
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2025-08-23, 1404/06/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.706
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Severity of ADHD symptoms
Timepoint
Week 0 - 5 - 10
Method of measurement
By ADHD Rating Scale (by parents and teacher)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Individuals receive methylphenidate (The dose will be adjusted based on standard clinical principles and tailored to the patient's weight and clinical response, within the range of 0.3 to 1.5 mg per kilogram of body weight per day). For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. They also receive a placebo twice a day.
Category
Placebo
2
Description
Intervention group: Individuals receive methylphenidate (The dose will be adjusted based on standard clinical principles and tailored to the patient's weight and clinical response, within the range of 0.3 to 1.5 mg per kilogram of body weight per day). For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. They also receive nanocurcumin at the dose of 20mg, twice per day. All medications are taken orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
TUMS, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5541 2222
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2026 to 2031
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Users should cite the resource of data
From where data/document is obtainable
Prof. Shahin Akhondzadeh
What processes are involved for a request to access data/document