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CTRI Number  CTRI/2023/07/054857 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 05/07/2023
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 Study to Evaluate the Efficacy of Abheerumuladi Ghrita in Children with Attention Deficit Hyperactivity Disorder 
Scientific Title of Study   Randomised Controlled Clinical Study to Evaluate the Efficacy of Abheerumuladi Ghrita in Children with Attention Deficit Hyperactivity Disorder 
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 BALASREE R JEEVAN 
Designation  PG SCHOLAR 
Affiliation  Sri Sri College of Ayurvedic Science and Research hospital, Bangalore 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9633891503  
Fax    
Email  drbalasreerjeevan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divyasri R A 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital Bangalore 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9448939421  
Fax    
Email  divya_mesha@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Divyasri R A 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital Bangalore 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9448939421  
Fax    
Email  divya_mesha@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital 
 
Primary Sponsor  
Name  Dr BALASREE R JEEVAN 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore KARNATAKA 560082 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 BALASREE R JEEVAN  Sri Sri College of Ayurvedic Science and Research Hospital Bangalore  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli 560082 Bangalore
Bangalore
KARNATAKA 
9633891503

drbalasreerjeevan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE BENGALURU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F902||Attention-deficit hyperactivity disorder, combined type. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Abheerumuladi Ghrita, Reference: Arogyarakshakalpadrumah 38/9, Route: Oral, Dosage Form: Ghrita, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -with food), Additional Information: Age wise dosage per day 7-8years - 7g 8.1-9years - 8g 9.1-10years - 9g 10.1-11years - 10g 11.1- 12years - 11g
2Comparator ArmDrugClassical(1) Medicine Name: Kushmanda Ghrita, Reference: AH.U.10/28, Route: Oral, Dosage Form: Ghrita, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: With food), Additional Information: Age wise dosage per day 7-8years - 7g 8.1-9years - 8g 9.1-10years - 9g 10.1 - 11years - 10g 11.1- 12years - 11g
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children in the age group of 7-12 years, irrespective of their gender, religion and socio- economic status.
2.Children fulfilling the diagnostic criteria of ADHD as per DSM 5.
3.Children whose parents are willing to sign the written consent form and follow the treatment protocol will be included. 
 
ExclusionCriteria 
Details  1.Children below 7 years and above 12 years of age will be excluded.
2.Children with other neurodevelopmental disorders and psychotic disorders like childhood Epilepsy, Mental Retardation, Pervasive Developmental Disorder not other-wise specified, Depression and Anxiety disorders, Rett’s syndrome, Conduct Disorder, Schizophrenia etc will be excluded.
3.Children with other systemic diseases will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of Attention Deficit Hyperactivity Disorder based on 33 items in ADHD T2 scale. Namely two sub scales -
1. Inattention
2. Hyperactivity/ Impulsivity 
Before intervention - 0th day
After intervention - 60th day, 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Attention Deficit Hyperactivity Disorder by assessing Lakshanas of vibhramas mentioned in unmada like
1. chesta vibhrama
2. Achara vibhrama
3. Bhakti vibhrama
4. Smriti vibhrama 
Before intervention - 0th day
After intervention - 60th day, 90th day 
 
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 
Date of First Enrollment (India)   20/07/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Child development refers to the sequence of physical, cognitive, emotional and social changes that occurs  from birth till the conclusion of adolescence.Cognitive skills allow children to understand the relationships between ideas, to grasp the process of cause and effect and to improve their analytical skills. Neurodevelopment is a part of cognitive development and neurodevelopmental dysfunctions reflect disruptions of neuroanatomic structure or psychophysiologic functions and may be associated with academic under achievement, behavioural difficulties and problems with social adjustment. Attention Deficit Hyperactivity Disorder (ADHD) is one of the common neurobehavioural disorder and  one of the most prevalent chronic health conditions affecting school aged children. It is mainly characterised by inattention, hyperactivity and impulsivity among children, adolescents and even in adults.  The prevalence of ADHD among children and adolescents in India (2009-2019) ranges from  7.6%–15%. The prevalence is more in male children (9.40%) than female children(5.20%). The peak prevalence in males is observed in the age group of 8-15 years and in females from 7.6 – 15 years. Children with ADHD have poor social interactions, thus they have poor relationships with parents, siblings and teachers. They are also poor in academics, thus, resulting in poor self esteem, peer rejection, inability to evaluate self and have negative emotions. The abnormal behaviour of the child is a major cause of concern for the parents as it affects their social status. This may eventually lead to psychological stress in parents and has serious implication on the quality of life of the family members.  Children with behavioural disorders are incredibly vulnerable to rejection and anger and they deserve to grow up in a safe environment, with warm acceptance from the society. Thus, interventions are required to tackle down this serious social burden. Currently psychosocial and behavioural therapies are widely adopted in the management of ADHD and to control the symptoms of ADHD psychostimulant drugs are being used rarely. The psychostimulant drugs used, increase the release and inhibit the reuptake of dopamine, thus enhancing attention span, concentration, and reducing impulsivity. They have no role in enhancing the academic performance of the child, but have severe adverse effects like sleep disturbances, irritability, growth suppression, adverse cardiovascular events like sudden cardiac death, and myocardial infarction.   ADHD can be considered under ‘Unmada’ spectrum of disorders in Ayurveda. The features like Cheshta Vibhrama(unsteadiness in activities), Ä€chara Vibhrama (perversion of conducts), Smriti Vibhrama (perversion of memory) and Bhakti Vibhrama (perversion of interest) of Unmada are predominantly observed in ADHD.   Ayurveda aims at correcting these Vibhramas by correcting the functions of Buddhi and Manas through various measures. One such time tested measure is administration of “Medhya Yogas”, which sharpens the cognitive skills of the child. Though several Medhya Yogas are mentioned in Ayurveda, only a handful of them have been evaluated in the treatment of ADHD, a disease which has multiple deficits.   Abheerumuladi Ghrita is one such formulation mentioned in Unmada Chikitsa which aims at correcting the Chestadi Vibhramas through its Medhya properties.   Hence, the Present study is an effort to evaluate the efficacy of Abheerumuladi Ghritha in children with Attention Deficit Hyperactivity Disorder.

 
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