| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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 Yogasâ€, 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. |