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CTRI Number  CTRI/2024/01/060989 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 20/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the Effect of Daily Abhyanga with Balaswagandha Lakshadi taila in Response Inhibition among Children with Hyperactivity. 
Scientific Title of Study   A Randomized Controlled Trial to Evaluate the Effect of Daily Abhyanga with Balaswagandha Lakshadi Taila in Response inhibition Among Children with Hyperactivity. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arathi M Nair 
Designation  PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Swasthavritta, Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O

Kollam
KERALA
690525
India 
Phone  8281150395  
Fax    
Email  starshine848@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vandana Rani M 
Designation  Professor and HOD 
Affiliation  Amrita School of Ayurveda 
Address  Department of Swasthavritta, Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O

Kollam
KERALA
690525
India 
Phone  9446441441  
Fax    
Email  drvandana@ay.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr Arathi M Nair 
Designation  PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Swasthavritta, Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O

Kollam
KERALA
690525
India 
Phone  8281150395  
Fax    
Email  starshine848@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda 
 
Primary Sponsor  
Name  Dr Arathi M Nair 
Address  Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri Clappana P.O, Kollam-690525, Kerala, India 
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 Arathi M Nair  Amrita School of Ayurveda  Department of Swasthavritta, Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O , Kollam -690525
Kollam
KERALA 		 8281150395

starshine848@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Amrita School of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: BALAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Behavioural modificationBehavioural modifications include physical activities, positive reinforcement, Alternate thought making and cognitive reframing.
2Intervention ArmProcedure-Abhyanga (Procedure Reference: Ashtanga Hridayam, Procedure details: The parents will receive guidance on how to perform Abhyanga, along with a handout explaining the oil massage techniques, frequency & duration, precautions and instructions for home care.It is recommended to perform Abyanga on the entire body, paying special attention to the sira,sravana and paada.)
(1) Medicine Name: Balashwagandha Lakshadi Taila, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Screened for hyperactivity using Conner Abbreviated Teacher Rating scale and selected subjects who has a score above 15
Consent from Parents / Guardian.
Assent.

 
 
ExclusionCriteria 
Details  Children who are under medication for epilepsy.
Children who have asthma and experience repeated or frequent episodes of asthma attacks.
Children with skin disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Response inhibition.  • At baseline, 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Hyperactivity  at baseline, 3 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 3 
Date of First Enrollment (India)   08/01/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is a Randomized Controlled Trial to evaluate the effect of Balaswagandha Lakshadi taila over Behaviour modification in Response Inhibition among children with Hyperactivity aged 7-12 years. Participants who meet the criteria for hyperactivity (who has a score above 15), as determined by the Conner’s Abbreviated Teacher rating scale will be separated into two group using simple random sampling technique. One group provided with behavioural modification and the other group with Abhyanga along with behavioural modification. 
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