A clinical trial to study the additional benefit of Ayurveda treatment along with Behavioral therapy in the management of Autism Spectrum Disorder.

Phase 3

Not yet recruiting

• Conditions: Autistic disorder. Ayurveda Condition: UNMADAH,

• Registration Number: CTRI/2023/05/052867
• Lead Sponsor: All India Institute of Ayurveda, New Delhi

Brief Summary

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social communication and interaction, as well as restricted, repetitive behaviors. Globally ASD is one of the fastest emerging neurodevelopmental disorder in young children recognized worldwide as evident from the fact that the global prevalence of Autism was estimated to be 61.9/10,000 in 2012.According to a systemic review, it is estimated that approximately 1 in 100 children are diagnosed with ASD around the world. India is the second largest population dense country with children less than 15 years constituting nearly one-third of the population. Though there is not enough studies available to estimate the prevalence rate of ASD in India, approximations show that more than two million people might be affected with ASD in India.

Methodology:

**STUDY DESIGN: Open Label Randomized Controlled Trial**

| | |

| --- | --- |

|Study Type

Randomized Controlled Clinical  Trial

|Purpose

Treatment

|Allocation

Block Randomization

|Masking

Open Label

|Control

Controlled

|Timing

Prospective

|End Point

Effectiveness

|No. of Groups

Two Groups

|Sample size

90 (45 in each group)

|Type of analysis

Intention to treat

**CRITERIA FOR SELECTION**

Children attending the *Kaumarabhritya* OPD, All India Institute of Ayurveda with features of Autism will be screened using Childhood Autism Rating Scale (CARS-2). Those fulfilling the cutoff scores for mild to moderate form of Autism i.e. 30 to 36.5 will be selected and enrolled in the study.

**INCLUSION CRITERIA**

•      Children between 3-9 years of age fulfilling the diagnostic criteria for mild to moderate form of Autism using Childhood Autism Rating Scale (CARS-2).

 â€¢       Parents / Guardian willing to give informed written consent to participate in the study.

**EXCLUSION CRITERIA**

•      Children with severe intellectual disability and diagnosed genetic and metabolic disorders.

•      Children currently on behavior therapy, occupational therapy, speech therapy, autism specific dietary intervention and any complementary and alternate medicine for Autism.

•      Children with chronic ailments like tuberculosis, malignancy, juvenile Diabetes mellitus and any other chronic systemic illness.

Children taking anti-epileptic and anti-psychotic drugs.

**INTERVENTION IN TRIAL GROUP**

**S.NO**

**GROUP A**

1.

*MAHAPAISHACHIKA GHRITA*

Orally for 12 weeks

2.

*SARASWATHA CHOORNA*

Orally for 12 weeks

3.

*CHITRAKADI VATI*

Orally for 12 weeks

4.

*HAPUSHA YAPANA BASTI*(Medicated Enema)

21 days (3 cycles of 7 days each)

5.

*NASYA* (Nasal administration of *Mahapaishachika Ghrita*)

42 days (3 cycles of 14 days each)

6.

BEHAVIOR THERAPY

(Applied Behavior Analysis)

12 weeks (Two 90 minute session per week )

**INTERVENTION IN CONTROL GROUP**

| | | |

| --- | --- | --- |

|**S.NO**

**GROUP B**

|1.

BEHAVIOR THERAPY

(Applied Behavior Analysis)

12 weeks (Two 90 minute session per week )

**PARAMETER FOR ASSESSMENT OF STUDY OUTCOMES**

**A.** **PRIMARY OUTCOMES**

Effect of the Ayurveda Treatment Protocol in reducing the core clinical features i.e. social communication and interaction and restricted, repetitive behaviors of ASD using Childhood Autism Rating Scale (CARS-2). (Timeframe: 0 day, 90th day and 180th day).

**A.** **SECONDARY OUTCOMES**

a)      Changes in the behavioral problems i.e. Irritability, Social Withdrawal, Stereotypic behavior, Hyperactivity and inappropriate speech using Aberrant Behavior Checklist. (Timeframe: 0 day, 90th day and 180th day).

b)      Changes in the adaptive and social functioning using Vineland Social Maturity Scale. (Timeframe: 0 day, 90th day and 180th day).

**FOLLOW UP:** 3 month at the end of completion of intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Children between 3-9 years of age fulfilling the diagnostic criteria for mild to moderate form of Autism using Childhood Autism Rating Scale (CARS-2) 2.Parents / Guardian willing to give informed written consent to participate in the study.

Exclusion Criteria

• 1.Children with severe intellectual disability and diagnosed genetic and metabolic disorders.
• 2.Children currently on behavior therapy, occupational therapy, speech therapy, autism specific dietary intervention and any complementary and alternate medicine for Autism.
• 3.Children with chronic ailments like tuberculosis, malignancy, juvenile Diabetes mellitus and any other chronic systemic illness.
• 4.Children taking anti-epileptic and anti-psychotic drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of the Ayurveda Treatment Protocol in reducing the core clinical features i.e. social communication and interaction and restricted, repetitive behaviors of ASD using Childhood Autism Rating Scale (CARS-2).	0 day, 90th day and 180th day

Secondary Outcome Measures

Name	Time	Method
Changes in the behavioral problems i.e. Irritability, Social Withdrawal, Stereotypic behavior, Hyperactivity and inappropriate speech using Aberrant Behavior Checklist.	Changes in the adaptive and social functioning using Vineland Social Maturity Scale.

Trial Locations

Locations (1)

All India Institute of Ayurveda, New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Ayurveda, New Delhi

🇮🇳South, DELHI, India

Dr Praveen Kumar Sharma

Principal investigator

9990177803

drpraveensharma1985@gmail.com