| CTRI Number |
CTRI/2024/06/069227 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
the efficacy of shatapushpa ghrita and shatavari ghrita in slow learners of childhood. |
|
Scientific Title of Study
|
Randomized comparative clinical study to evaluate the efficacy of Shatapushpa Ghrita and Shatavari Ghrita in slow learners of childhood. |
| 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 Veena |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
9341319933 |
| Fax |
|
| Email |
veenapanchal93413@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheer B R |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
9900175777 |
| Fax |
|
| Email |
sudheerbrao@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudheer B R |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
9900175777 |
| Fax |
|
| Email |
sudheerbrao@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Veena |
| Address |
Sri Sri College of Ayurvedic science and Research hospital 21st KM kanakpura main road, udayapura post, bengluru 560082 |
| 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 Veena |
Sri Sri College of Ayurvedic and Research Hospital, Bangalore |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA |
9341319933
veenapanchal93413@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL 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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shatapushpa ghrita, Reference: kashyapa samhita, Route: Oral, Dosage Form: Ghrita, Dose: 8(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Ksheera), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shatavari ghrita, Reference: kashyapa samhita, Route: Oral, Dosage Form: Ghrita, Dose: 8(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Ksheera), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the age group 7 to 9 years irrespective of gender, religion, and socio- economic status.
2. Children fulfilling the diagnostic criteria of Slow learners.
3. Children with IQ between 80 and 90 will be included.
4. Children of those parents who are willing to sign the written consent form will be included.
|
|
| ExclusionCriteria |
| Details |
1. Children with sensory impairment will be excluded.
2. Children clinically diagnosed with seizures, psychiatric disorders, and other neurodevelopment disorders like Mental retardation, ADHD, and ASD will be excluded.
3. Children with Congenital and Genetic disorders will be excluded.
4 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
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in the IQ and academic performance of Slow learners of childhood.
|
0 - 30 - 60 and 90 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generation of in-depth analyzed data on Slow learners in the different aspects of the disease. |
6 - 9 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="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
|
Intelligence plays a significant role in the development and well-being of children. Children exhibit variations in their physical attributes, intellectual capacities, academic performance, emotional characteristics, and cultural background. Intelligence is used to talk about the property of the entire human cognitive system.
Cognitive systems attain maturity gradually which involves the progressive building of learning skills, such as attention, memory and thinking. Cognitive skills are crucial for children to achieve high academic standards. In today’s fiercely competitive society, limited intellectual capabilities can lead to a significant challenge. It has been estimated that 5 to 15 percent of school-going children suffer from scholastic backwardness.
A Slow Learner is a child of below-average intelligence whose thinking skills and scholastic performance have developed significantly more slowly than the pace of his or her age with an IQ of 80-90. Neglecting them in terms of appropriate support may result in a decline in their academic motivation, potentially leading to alienation from school, school dropout, sometimes social maladjustment. This in turn attributes to low self- esteem, lack of goal-setting, problem-solving skills, poor memorizing abilities, poor peer relationships, etc. Educational Institutions have undertaken numerous initiatives to identify, and observe through scholastic performance (throwing light on areas like arithmetic, Reading, spelling etc.), and formulate remedial strategies for such children to enhance their learning abilities and support them. Slow leaners still struggle to attain the expected standards, despite the efforts made by the educational institutions and parents.
Intellectual functioning can be correlated to Medha(cognition) or Buddhi (Knowledge) in Ayurveda, whose proper functioning leads to Samyak Inyana (proper knowledge) and dysfunction leads to improper cognitive development.
Slow learners face auditory perceptual and visual motor problems. Thus in slow learners there is an insufficient processing of information to be learned, by the brain. The Manas is inefficient in obtaining Samyak Inyana through Shrotra and Chakshurendriya and the further processing of the Inyana obtained is insufficient due to Karma Kshaya of the Buddhi having implication on Dhriti and Smriti resulting in weak memory and poor retention power.
There are ample Medhya (cognition) drugs mentioned in Ayurveda. The effect of these medicine on improving Dhee, Dhriti, and Smriti needs to be evaluated. Two such formulations have been mentioned in Kashyapa Samhitha, namely Shatavari Ghrita and Shatapushpa Ghrita." Both are said to be Smritivardhaka (memory), Medhavardhaka (cognition), and Matikara along with being Balya and Ojasya due to the virue of the drugs in the form of Ghrita. 8.9 Continuous use of these drugs for a month makes a person Shrutadhara. le improve the learning skills and become a fast learner. Considering the effect on learning, this study entitled "Randomized comparative clinical study to evaluate the efficacy of Shatapushpa Ghrita and Shatavari Ghrita in slow learners of childhood" has been chosen. |