Combination of Supplements for Treating Autistic Spectrum Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-09-30

Brief Summary

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A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder.

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Detailed Description

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A prospective, double-blind, placebo-controlled, crossover, multicentre clinical study which will enrol up to 45 children diagnosed with ASD (enrolment will stop when 40 children have completed the study). Children ages 3-14 will be tested before and after administering the combination of active substances (3 months) and placebo (3 months). The duration of participation in the study for each child will be 6 months. The supplements tested consist of three products - a combination of apitherapy and plant extracts - which have been approved for sale as individual supplements for more than 5 years in Romania - Apicol 12 gamma, Laptisor de matca activat (Royal Jelly) and Telom R Cerebral. Participation in the study is free and all children will be comparatively evaluated with the ATEC and ASRS scales and three sets of blood tests.

Conditions

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Autism Spectrum Disorder (ASD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

prospective, double-blind, placebo-controlled, crossover, multicenter

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active combination

A combination of 3 supplements with royal jelly and various plant extracts

Group Type ACTIVE_COMPARATOR

A combination of apitherapy and plant extracts

Intervention Type DIETARY_SUPPLEMENT

This combination contains the active comparator

Placebo combination

A combination of 3 products with identical look and colour

Group Type PLACEBO_COMPARATOR

Placebo Combination

Intervention Type COMBINATION_PRODUCT

A combination containing inert substances - placebo

Interventions

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A combination of apitherapy and plant extracts

This combination contains the active comparator

Intervention Type DIETARY_SUPPLEMENT

Placebo Combination

A combination containing inert substances - placebo

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* age 3-14 years
* diagnosed with typical or atypical autism spectrum disorder (F84.0 or F84.1) and received at least one therapeutic intervention before enrolling
* the ability to follow an oral treatment, with TID/BID/QD administration
* the availability to perform 3 sets of blood tests at a clinical laboratory within 6 months (initial, at 3- and 6-months)
* the availability to perform 3 visits to the Investigator and 3 psychometric evaluations within 6 months

Exclusion Criteria

* patients enrolled in another interventional clinical trial currently or which ended less than 1 month prior to enrolling in this study
* known allergy to hive products or one of the substances studied
* inability to perform the study requirements (3 visits to the Investigator, 3 psychometric assessments, 3 sets of blood tests)
* diagnosis of diabetes
* history of seizures/epilepsy
* administration of anticoagulants, antiplatelets, thrombolytic agents, low molecular weight heparins, anticonvulsants, insulin, monoamine oxidase inhibitors, non-steroidal anti-inflammatory drugs or thiazide diuretics
* allergy to celery and other plants of the Fam. Apiaceaea (Umbelliferae)
* abnormally elevated baseline (at V1) values of ferritin, homocysteine, HgbA1c, ESR

Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No