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CTRI Number  CTRI/2023/06/053839 [Registered on: 13/06/2023] Trial Registered Prospectively
Last Modified On: 03/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to evaluate the effect of virechana karma followed by kalyanaka kashaya and kalyanaka kashaya in the management of childhood autism 
Scientific Title of Study   A comparative clinical study to evaluate the effect of virechana karma followed by kalyanaka kashaya and kalyanaka kashaya in the management of childhood autism 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VASUKI RAO N 
Designation  PG SCHOLAR  
Affiliation  SDM INSTITUTE OF AYURVEDA AND HOSPITAL 
Address  OPD-7,8,9 Ground Floor Department of Kaumarabhrtiya SDM INSTITUTE OF AYURVEDA AND HOSPITAL NH 275, Anchepalya, Bengaluru, Karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  9686802779  
Fax    
Email  vasukirao.n@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr POORNIMA N  
Designation  ASSOCIATE PROFESSOR  
Affiliation  SDM INSTITUTE OF AYURVEDA AND HOSPITAL 
Address  OPD-7,8,9 Ground Floor Department of Kaumarabhrtiya SDM INSTITUTE OF AYURVEDA AND HOSPITAL NH 275, Anchepalya, Bengaluru, Karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  9590770170  
Fax    
Email  dr.poornimaravish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr POORNIMA N  
Designation  ASSOCIATE PROFESSOR  
Affiliation  SDM INSTITUTE OF AYURVEDA AND HOSPITAL 
Address  OPD-7,8,9 Ground Floor Department of Kaumarabhrtiya SDM INSTITUTE OF AYURVEDA AND HOSPITAL NH 275, Anchepalya, Bengaluru, Karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  9590770170  
Fax    
Email  drpoornimaraveesh@gmail.com  
 
Source of Monetary or Material Support  
SDM Institute of Ayurveda and Hospital Anchepalya Bengaluru 
 
Primary Sponsor  
Name  DR VASUKI RAO N  
Address  SDM INSTITUTE OF AYURVEDA AND HOSPITAL NH 275, Anchepalya, Bengaluru, Karnataka 560074 
Type of Sponsor  Other [SELF ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr VASUKI RAO N   SDM INSTITUTE OF AYURVEDA AND HOSPITAL   OPD-7,8,9 Ground Floor Department of Kaumarabhrtiya SDM INSTITUTE OF AYURVEDA AND HOSPITAL NH 275, Anchepalya, Bengaluru, Karnataka 560074
Bangalore
KARNATAKA 		 9686802779

vasukirao.n@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F948||Other childhood disorders of social functioning. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: CHARAKA, Procedure details: DEEPANA WITH CHITRAKADI VATI FOR 3 DAYS SNEHAPANA WITH SWALPACHETASA GRITHA FOR 3 TO 5 DAYS ABHYANGA WITH MOORCHITHA TAILA FOR 4 DAYS VIRECHANA WITH TRIVRUTH LEHYA )
(1) Medicine Name: KALYANAKA KASHAYA, Reference: ASHTANGA HRUDAYA , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(ml), Frequency: bd, Duration: 30 Days
2Comparator ArmDrugClassical(1) Medicine Name: KALYANAKA KASHAYA, Reference: ASHTANAGA HRUDAYA , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: JALA ), Additional Information: 5-10 YEARS-10 ML 11-16 YEARS-20 ML
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in the hyper activity
2.Improvement in the eye contact
3.Improvement in the sensory issues
4.Improvement in the behavioral patterns
5.improvement in social reciprocity
 		 1 MONTH 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  - 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   13/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

 
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