Clinical study on the effect of Kalyanaka Kashaya, Kalyanaka Ghrita and Takradhara in gut health of children with Autism Spectrum Disorder

EFFECT OF KALYANAKA KASHAYA, KALYANAKA GRITHA AND TAKRADHARA IN IMPROVING GUT HEALTH OF CHILDREN WITH AUTISM SPECTRUM DISORDERS IN THE AGE GROUP 3 TO 12 YEARS IN COMPARISON TO A CONTROL OF BEHAVIORAL THERAPY AND DIETARY MODIFICATIONS - A NON-RANDOMISED CONTROLLED CLINICAL TRIAL - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101663

Enrollment

Registered

2026-01-20

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

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: ASD Diagnosed according to DSM 5 criteria ASD with gastric symptoms assessed using GSSS

Exclusion criteria

Exclusion criteria: ASD children with comorbid psychiatric disorders. Known GI issues unrelated to ASD Recent antibiotic use (within one month before study commencement) Currently undergoing probiotic or antibiotic therapy.

Design outcomes

Primary

Measure	Time frame
To assess the GSSS ScoreTimepoint: 0th, 15th, 30th day	—

Secondary

Measure	Time frame
To assess the change in Serum Zonulin levels. To assess the change in inflammatory markers IL1beta and IL10 post intervention To assess the clinical signs of autism based on ISAA and ATEC scores.Timepoint: 0th, 30th day	—

Countries

India

Contacts

Public ContactDr Roshni Anirudhan

Govt Ayurveda College Hospital for Women and Children, Poojapura

doctoroshni@gmail.com9447006585

Outcome results