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CTRI Number  CTRI/2021/04/033238 [Registered on: 29/04/2021] Trial Registered Prospectively
Last Modified On: 28/04/2021
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 Ashtamangala ghrita in Developmental Learning Disorder in Children 
Scientific Title of Study   Randomized Controlled Clinical study to evaluate the efficiency of Ashtamangala ghrita in Developmental Learning Disorder in Children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megha G 
Designation  PG Scholar  
Affiliation  Sri Sri College of Ayurvedic science and Research 
Address  Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura road, Udayapura post, Bengaluru

Bangalore
KARNATAKA
560082
India 
Phone  7204992517  
Fax    
Email  drmeghagopi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudheer BR 
Designation  H.O.D, Professor, Department of PG studies in Kumarabhritya 
Affiliation  Sri Sri College of Ayurvedic science and Research 
Address  Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura road, Udayapura post, Bengaluru

Bangalore
KARNATAKA
560082
India 
Phone  9900175777  
Fax    
Email  sudheerbrao@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Megha G 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura road, Udayapura post, Bengaluru

Bangalore
KARNATAKA
560082
India 
Phone  7204992517  
Fax    
Email  drmeghagopi@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road,Udayapura post 
 
Primary Sponsor  
Name  Sri Sri College of Ayurvedic science and Research Hospital 
Address  Sri Sri College of Ayurvedic Science and Research Hospital, 21st Km, Kanakapura road, Udayapura post, Bengalur 
Type of Sponsor  Private medical college 
 
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 Sudheer BR  Sri Sri College of Ayurvedic Science and Research  OPD no.9, department of PG studies in Kaumarabhritya, 21st Km, Kanakapura road, Udayapura post
Bangalore
KARNATAKA 
9900175777

sudheerbrao@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Intuitional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F819||Developmental disorder of scholastic skills, unspecified. Ayurveda Condition: MANOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AshtamangalA Ghrita (Ghee)  To be given internally for 60days of duration, dose according to age.(8 to 9 years- 8ml, 9 to 10 years -9ml, 10 to 11 years - 10ml, 11 to 12 years - 11ml) 
Comparator Agent  Saraswata Churna   To be given orally for 60 days of duration, dose according to age(8 to 10 years - 5grams, 10-12 years - 6grams) 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children in the age group 8 to 12 years with Developmental learning disorder, irrespective of gender, religion and socio-economic status.
b) Children of those parents who are willing to sign the written consent form will be included.
 
 
ExclusionCriteria 
Details  ) Children in the age group below 8 years and above 12 years will be excluded.
b) Children with sensory impairment will be excluded.
c) Children clinically diagnosed with seizures, psychiatric disorders and other neurodevelopment disorders like ADHD, ASD will be excluded.
d) Children with Congenital and Genetic disorder will be excluded.
e) Children with chronic systemic illness, requiring regular medications will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ashtamangala Ghrita is effective in Developmental learning disorder i.e. their will be improvement in reading, writing and calculations/mathematics, it will be assessed with NIMHANS index for SLD.  1st day, 60days, 90days 
 
Secondary Outcome  
Outcome  TimePoints 
Saraswata Churna was proved to be effective in treating Dyslexia, one among the Developmental learning disorder, so it will be effective in all the parameters of Developmental learning disorder, i.e. Dyslexia, Dysgraphia and Dyscalculia.  1st day, 60days, 90days. 
 
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)   28/05/2021 
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="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The physical, social and emotional development of young children has a direct effect on their adulthood.

Reading and writing is a form of communication and communication becomes limited in absence of these skills. These skills develop the mind, imagination and creativity and the child discovers new things. During concrete operational stage of cognitive development, children develop logical thinking and reasoning, their reading and writing skills also matures during this phase. The initial difficulties faced in learning may continue to persist in later life and the child may have to face challenges in the competitive world.

Learning disorders are among the most frequently diagnosed developmental disorders in childhood. There are many different kinds of learning disabilities and they can affect children differently.

Learning disabilities refer to ongoing problems in one of three areas, reading (dyslexia), writing (dysgraphia) and mathematics (dyscalculia), which are foundational to one’s ability to learn. The treatment of DLD is only remedial education by introduction of special education training program effectively. With all research efforts so far no specific medication is proven effective. Administration of internal medications along with special training shall be a better approach to DLD.

Learning disability can be understood as a defective processing of knowledge; involving  Dhee (power of acquisition), Dhriti (retention), Smriti (memory), Manas (mind) and Buddhi (knowledge). Medhya dravyas (Nootropics) which influence the above factors enhance the learning process there by correcting the learning difficulties. Ghrita (ghee) is known as wholesome to all humans irrespective of the age. It imparts Dhee, Smriti, Medha as it is known to cross the blood brain barrier. Ashtamangala ghrita is one of the Medhya yoga, mentioned in Chakradatta. It has the capacity to render Dridha smriti, Kshipra medha (instant intelligence) and makes the child Buddhiman (intelligent). 

Very few studies have been conducted with regard to the Ayurvedic approach of Developmental learning disorder. Thus this study is an effort to explore the lesser known facts on the effect of Ashtamangala ghrita on DLD.

 
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