A clinical study to evaluate the effect of virechana karma followed by kalyanaka kashaya and kalyanaka kashaya in the management of childhood autism

Phase 2/3

Not yet recruiting

• Conditions: Other childhood disorders of social functioning. Ayurveda Condition: UNMADAH,

• Registration Number: CTRI/2023/06/053839
• Lead Sponsor: DR VASUKI RAO N

Brief Summary

This study is a randomized, open lablled,parallel group, comparing the efficacy of virechana karma followed by oraladministration of kalyanaka Kashaya in dose of 10 ml or 20 ml according to age dailyand only oral administration of kalyanaka Kashaya 10 ml or 20 ml according toage daily in 30 children diagnosed with childhood Autism that will be conductedin single centre i.e SDM Institute of Ayurveda in India.The primary outcomemeasures will be reduction in hyperactivity,  Improvement in the eye contact,Improvement inthe sensory issues,Improvement in the behavioral patterns, improvement insocial reciprocity and secondary measures like reduction in scores of MCHAT andISAA.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-06
• Study Start: 2023-06-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Children diagnosed with autism 2.5-16 years 3.Children of either gender 4.Children whose parents are willing to sign the informed assent.

Exclusion Criteria

• 1.Children aged below 5 years 2.Children above 16 years of age.
• 3.Children with co- morbidities such as uncontrolled seizures, bi-polar disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in the hyper activity	1 MONTH
4.Improvement in the behavioral patterns	1 MONTH
5.improvement in social reciprocity	1 MONTH
2.Improvement in the eye contact	1 MONTH
3.Improvement in the sensory issues	1 MONTH

Trial Locations

Locations (1)

SDM INSTITUTE OF AYURVEDA AND HOSPITAL; 🇮🇳 Bangalore, KARNATAKA, India

SDM INSTITUTE OF AYURVEDA AND HOSPITAL

🇮🇳Bangalore, KARNATAKA, India

Dr VASUKI RAO N

Principal investigator

9686802779

vasukirao.n@gmail.com