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This randomized controlled trial aims to evaluate the efficacy of a combination of photo-biomodulation at acupuncture points, autologous platelet-rich plasma (PRP), and umbilical cord-derived exosome therapy in children with Autism Spectrum Disorder (ASD). The study will compare these interventions against standard care to determine their impact on the severity of autism symptoms, as measured by the Childhood Autism Rating Scale (CARS) and other related markers.
The study involves three main interventions:
The study will run over a period of 6 months, with follow-ups and assessments at each phase. The primary outcome measure will be the change in CARS score, with secondary outcomes including additional ASD markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Experimental | Standard Care: Procedure: Routine conventional Applied Behavioral Analysis (ABA) management and interventions for ASD, as per current clinical guidelines. |
|
| Experimental Group | Experimental | The Group may be provided with three interventions and then compared with the control group in order to evaluate the effects of the said interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photo-Biomodulation | Device | Application at acupuncture points for 20 seconds each week. using 810nm Laser probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Childhood Autism Rating Scale (CARS) Score (15-60) | Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism. | Baseline |
| Change in Childhood Autism Rating Scale (CARS) Score (15-60) | Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism. | 12 Weeks |
| Change in Childhood Autism Rating Scale (CARS) Score (15-60) | Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism. | 6 Months |
| Change in Childhood Autism Rating Scale (CARS) Score (15-60) | Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) | It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism) | Baseline |
| Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) |
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Inclusion Criteria:
• Diagnosis of Autism Spectrum Disorder based on DSM-5 criteria
Exclusion Criteria:
• Severe comorbid medical conditions
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahzad Anwar, MBBS, DOM | Contact | 0092 0300 9400049 | shahzadtirmzi@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iffat Anwar Medical Complex | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
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| Autologous PRP | Biological | IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45. |
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| Exosome Therapy | Biological | IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes |
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| Standard Care (in control arm) | Other | Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD) |
|
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism) |
| 12 Weeks |
| Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) | It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism) | 6 Months |
| Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) | It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism) | 1 Year |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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