Efficacy of Hingvastaka Churna Arka with Vilvadi Gutika in reducing Functional Gastrointestinal Disorders in children with Autism Spectrum Disorders, aged between 3- 10 years.

Efficacy of Hingvastaka Churna Arka with Vilvadi Gutika in the management of Functional Gastrointestinal Disorder in children with Autism Spectrum Disorder: A Randomized Controlled Trial. - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102631

Enrollment

Registered

2026-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder Health Condition 2: K599- Functional intestinal disorder, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Parents or legal guardians who provide informed consent/ assent and demonstrate willingness to ensure full compliance with the study protocol. 2. Children of either gender, aged between 3 and 10 years, diagnosed with Autism Spectrum Disorder as per DSM-5 TR criteria and screened positive on the M-CHAT-R tool. 3. Children diagnosed with Autism Spectrum Disorder presenting with 2 or more items on the 6-GSI Scale and the ROME IV Criteria for the diagnosis of Functional Gastrointestinal Disorders.

Exclusion criteria

Exclusion criteria: 1. History of prebiotic or probiotic use within the past three months, use of laxatives, or adherence to special diets or food restrictions. 2. Presence of any acute infections and is undertaking any specific pharmacological treatments for the same. 3. Children with Autism Spectrum Disorder presenting with other co-morbid systemic illnesses, or any other chronic neurological or metabolic disorders.

Design outcomes

Primary

Measure	Time frame
End point assessment for the reduction in the symptoms of Functional Gastrointestinal disorders will be done based on the 6 Gastrointestinal Severity Index Scale and Gastrointestinal Symptom Rating Scale- GSRS Scale.Timepoint: 30 days	—

Secondary

Measure	Time frame
Reduction in Autism Spectrum Disorder-related manifestations based on the Autism Treatment Evaluation Checklist (ATEC) based on Parental feedback.Timepoint: 30 days	—

Countries

India

Contacts

Public ContactDr K Smruthi

SDM Institute of Ayurveda and Hospital, Bangalore

drreenakulkarni@gmail.com9480478639

Outcome results