| CTRI Number |
CTRI/2025/03/083208 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know effect of astanga ghrita nasya and astanga granules in low average intelligence in 5th standard children
|
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Scientific Title of Study
|
A Clinical study to evaluate efficacy ofastanga ghrita nasyaand astanga granules internally in 5th standard of low average intelligence |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Inchara P |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Univarsity Of Health Sciences,Bangalore |
| Address |
Room number 16, Ground floor Department of Kaumarabhritya Sri Dharmasthala Manjunateshwara Ayurveda College and Hospital Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9164460383 |
| Fax |
|
| Email |
incharaprakash24@gmail com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Kumar S |
| Designation |
Associate Professor |
| Affiliation |
Rajiv Gandhi University of Healthcare Science, Bangalore |
| Address |
Room Number 16 Department of Kaumarabhritya Sri Dharmasthala manjunateshwara Ayurveda College and Hospital hassan Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
8197589426 |
| Fax |
|
| Email |
drnayankumar@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan Kumar S |
| Designation |
Associate Professor |
| Affiliation |
Rajiv Gandhi University of Health sciences Bangalore |
| Address |
Room Number 16 Ground floor Department of Kaumarabrithya Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 Karnataka India
Hassan,KARNATAKA
Hassan
KARNATAKA
573201
India |
| Phone |
8197589426 |
| Fax |
|
| Email |
drnayankumar@sdmcahhassan.org |
|
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Source of Monetary or Material Support
|
| 1. Department of Kaumarabhritya Sri Dharmasthala manjunateshwara Ayurveda College and Hospital Hassan 573201, Karnataka,India |
| Department of Kaumarabhritya Sri Dharmasthala manjunateshwara Ayurveda College and Hospital Hassan 573201 Karnataka India |
|
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Primary Sponsor
|
| Name |
Dr Inchara P |
| Address |
Sri Dharmasthala Manjunateshwara Ayurveda College and Hospital hassan 573201 Karnataka,India |
| Type of Sponsor |
Other [Other] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Inchara P |
Sri Dharmasthala manjunateshwara Ayurveda College hospital |
OPD Department of Kaumarabhritya,Thanniruhalla, BM road, Hassan
Hassan
KARNATAKA |
9164460383
incharaprakash24@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe SDM |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F70||Mild intellectual disabilities. Ayurveda Condition: BUDDHIMANDYAM (KEVALA-KAPHA), |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Astanga hridaya, Procedure details: Astanga ghrita 6 drops to each nostril is instilled for 2 times in a day for 45 days)
(1) Medicine Name: Astanga ghrita , Reference: Astanga hridaya , Route: Nasal, Dosage Form: Ghrita, Dose: 6(drops), Frequency: bd, Duration: 45 Days |
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. The children of either gender studying in 5thstandard fulfilling the diagnostic criteria.
2. Children whose parents are willing to participate the in the study after giving informed parent consent and oral assent by child. |
|
| ExclusionCriteria |
| Details |
1.Children with learning disabilities or any other neuro-cognitive dysfunction like ADHD,Autism.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined effect of astanga ghrita nasya and astanga granules orally in 5th standard children of low average 1q |
Initially screening is done with Draw man test then assessment on 1st day with binet kamath scale of intelligence and reassessment is done on 45th day after treatment using binet kamath scale of intelligence |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined effect of astanga ghrita nasya and oral administration of astanga granules in 5th standard children with low average IQ. |
Assesment 1st day before treatment and 45days after treatment |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
In today’s competitive world, assessing a child’s intelligence is crucial for their academic and extracurricular success. Intelligence, involves cognitive abilities like acquiring, storing, and reproducing knowledge1. In Ayurveda, intelligence is described through terms like buddhi, smriti, medha, dhi, and dhruti, highlighting deep and comprehensive knowledge2. Every child is unique, distinguished by their intelligence, learning skills, activities, memory, and courage. Lower IQ levels are associated with decreased happiness and poorer health outcomes3. Studies indicate that about 6-7% of the population has low average intelligence, affecting their school performance4. A survey conducted in and around Hassan found that 2% of children has low average intellectual capacity5.It’s observed that 15-20% of students in a classroom struggle academically to excel in their academics 6. Low average intelligence is a person possessing below average cognitive ability(generally an IQ 0f 75-86 through Binet kamath test of intelligence7 which is indicative of less school performance. Children with lower average intelligence are at risk of long-term learning difficulties, poor reasoning, planning, and abstract thinking. Without appropriate support, they may face academic, social, and emotional challenges leading to personal and professional setbacks.
Interventions to enhance intellectual development can significantly benefit these children. Ayurvedic literature mentions medhya dravyas (nootropic substances)8 that can boost brain function. Astanga ghrita, an Ayurvedic formulation mentioned in astanga hridaya, is known for its nervine tonic properties, especially beneficial for children which is medhavardaka, smritivardaka (improves memory)and budhivardaka (improves intellectual capacity,cognition and perception). It contains ingredients like mandukaparni, shankapushpi, brahmi, and amrita,9 known for their cognitive-enhancing effects.Administering Astanga ghrita as nasya (nasal medication) can stimulate higher brain centers, enhancing neurological functions. Astanga ghrita is formulated into palatable granules, making it easier for children to consume.
Though earlier studies conducted on intellectual disabilities, their were no attempts made to provide medication in nasal route thus this study becomes unique in exploring the effects of ashtanga ghrita nasya and as granules for supporting children’s cognitive development , academic performance and overall well-being. |