Exploring curcumin's role in easing irritability in kids with autism
| ISRCTN | ISRCTN13881401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13881401 |
| Secondary identifying numbers | IR.TUMS.VCR.REC.1400.4669 |
- Submission date
- 20/11/2023
- Registration date
- 23/11/2023
- Last edited
- 23/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Curcumin is a compound found in turmeric, a spice often used in traditional medicine. Some studies have suggested that curcumin may have potential therapeutic effects due to its anti-inflammatory and antioxidant properties. Inflammation and oxidative stress have been implicated in various neurological disorders, including autism. However, it's crucial to note that the research in this area is still emerging, and more robust clinical trials are needed to establish the effectiveness and safety of curcumin for treating autism. The aim of this study is to assess the efficacy of curcumin in the treatment of autism
Who can participate?
Children between the ages of 3 and 12 years with autistic disorder attending Roozbeh Hospital
What does the study involve?
The participants will be randomly allocated into two groups. The intervention group will receive curcumin and risperidone and the control group will receive risperidone for 12 weeks.
What are the possible benefits and risks of participating?
There is no risk in participation, but those participating in the study will benefit from the potential therapeutic effects of curcumin.
Where is the study run from?
Roozbeh Hospital (Iran)
When is the study starting and how long is it expected to run for?
April 2022 to May 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mohammad Farhadi-Shahi, mohammad.farhadi.md@gmail.com
Contact information
Public, Scientific, Principal Investigator
Tehran University of Medical Sciences
Poursina St
Tehran
1419783151
Iran
| Phone | +98 (0)2122324489 |
|---|---|
| mohammad.farhadi.md@gmail.com |
Study information
| Study design | Randomized double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Curcumin as an adjunctive treatment for irritability in children with autism spectrum disorder: a randomized, double-blind, placebo-controlled clinical trial |
| Study hypothesis | Curcumin leads to improvement of irritability in children with autism spectrum disorder |
| Ethics approval(s) |
Approved 01/04/2022, Institutional review board/ethics committee of Tehran University of Medical Sciences (North Kargar St, Poursina St, Tehran, 1419783151, Iran; +98 (0)2122324489; VCR@tums.ac.ir), ref: IR.TUMS.VCR.REC.1400.4669 |
| Condition | Autism spectrum disorder |
| Intervention | Permuted randomized blocks (blocks of four, allocation ratio 1:1) will be used by an independent party, who was not involved elsewhere in the trial, to generate the randomization codes. Allocation concealment will be achieved by sequentially numbered, sealed opaque envelopes. Patients, the physician who assessed the outcomes, and the statistician will be blinded to the treatment allocation. Participants will be randomly allocated into two groups. The intervention group (25 people) will receive curcumin (50 to 150 micromol/day) and risperidone (1 to 3.5 mg per day) and the control group (25 people) will receive risperidone (1 to 3.5 mg per day) for 12 weeks. Participants in both groups will receive risperidone in a similar manner. The starting daily dose of risperidone will be 0.25 mg in children weighing <20 kg and 0.5 mg in children weighing ≥20 kg. Curcumin (ACER, Tehran, Iran) will be prescribed at 50 μmol and 100 μmol (approximately 10 mg and 20 mg) per day for patients weighing <45 kg and 45–90 kg, respectively. |
| Intervention type | Supplement |
| Primary outcome measure | Irritability is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 |
| Secondary outcome measures | 1. Lethargy/social withdrawal is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 2. Stereotypic behavior is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 3. Inappropriate speech is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 4. Hyperactivity/noncompliance is measured using the Aberrant Behavior Checklist (ABC) at baseline, week 4, week 8, and week 12 |
| Overall study start date | 01/04/2022 |
| Overall study end date | 01/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Children aged 4–12 years 2. Male or female 3. Outpatients referred to clinic with probable autistic signs and symptoms and who meet the DSM-5 criteria |
| Participant exclusion criteria | 1. Concurrent prominent psychiatric disorder 2. Preexisting medical conditions (in particular epileptic disorders and febrile seizures) 3. Intellectual disability (IQ <70) 4. History of drug or alcohol abuse 5. History of tardive dyskinesia 6. History of taking antipsychotic medication within 6 months prior to enrollment |
| Recruitment start date | 01/01/2024 |
| Recruitment end date | 01/03/2024 |
Locations
Countries of recruitment
- Iran
Study participating centre
Tehran
1439957181
Iran
Sponsor information
Hospital/treatment centre
North Kargar St, Poursina St
Tehran
1439957181
Iran
| Phone | +98 (0)2122324489 |
|---|---|
| VCR@tums.ac.ir | |
| Website | http://roozbehhospital.tums.ac.ir/ |
"ROR" |
https://ror.org/019mzt973 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The draft and data will be distributed through final report |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
23/11/2023: Study's existence confirmed by the Tehran University of Medical Sciences.
