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
|
|
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
|
|
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. |