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CTRI Number  CTRI/2024/10/075537 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic treatment for improvement of cognition in Cerebral palsy. 
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of panchabhautika ghrita nasya over asta mangala ghritha nasya for cognitive enhancement in children with cerebral palsy. 
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 Radhika Injamuri 
Designation  PhD Scholar 
Affiliation  Sri Sri college of Ayurveda and Research Hospital, Cuttack, Odisha 
Address  Department of Kaumarabhritya, Sri Sri College of Ayurveda and research hospital, Sri Sri University, Sri Sri Vihar, Ward No – 3 Godi Sahi, Cuttack, Odisha, India

Cuttack
ORISSA
754006
India 
Phone  9108304745  
Fax    
Email  raadhika.ayu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Durga Prasad Dash 
Designation  Professor and Head of the department 
Affiliation  Sri Sri College of Ayurveda and Research Hospital, Cuttack,Odisha 
Address  Department of Kaumarabhritya, Sri Sri College of Ayurveda and research hospital, Sri Sri University, Sri Sri Vihar, Ward No – 3 Godi Sahi, Cuttack, Odisha, India


ORISSA
754006
India 
Phone  9108304745  
Fax    
Email  durga.d@srisriuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Radhika Injamuri 
Designation  PhD Scholar 
Affiliation  Sri Sri college of Ayurveda and Research Hospital, Cuttack, Odisha 
Address  Department of Kaumarabhritya, Sri Sri College of Ayurveda and research hospital, Sri Sri University, Sri Sri Vihar, Ward No – 3 Godi Sahi, Cuttack, Odisha, India


ORISSA
754006
India 
Phone  9108304745  
Fax    
Email  raadhika.ayu@gmail.com  
 
Source of Monetary or Material Support  
Self-financed study as a part of PhD thesis. Dr.Radhika Injamuri, PhD Scholar, Department of Kaumarabhritya, Sri Sri College of Ayurveda and research hospital, Ward No.3, Sandhapur, Godisahi, Cuttack-754006, Odisha, India.  
 
Primary Sponsor  
Name  Dr Radhika Injamuri 
Address  PhD Scholar, Department of Kaumarabhritya, Sri Sri College of Ayurveda and research hospital, Ward No.3, Sandhapur, Godisahi, Cuttack-754006, Odisha, India. Sri Sri Vihar, Ward No – 3 Godi Sahi, Cuttack, Odisha, India. 
Type of Sponsor  Research institution and hospital 
 
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 Radhika Injamuri  Shree Jagadguru Gavisiddheshwara Ayurvedic hospital  Kaumarabhritya OPD, Room no.13, Shree Jagadguru Gavisiddheshwara Ayurvedic medical college and hospital, Gavimath Campus, Koppal-583231.
Koppal
KARNATAKA 
9108304745

raadhika.ayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam, नस्यम् (Procedure Reference: Kashyapa samhita, Procedure details: Panchabhutika ghrita Nasya of 2drops will be instilled Intra-nasally once in a day in the Morning on an empty stomach. )
(1) Medicine Name: Panchabhutika ghrita, Reference: Kashyapa samhita, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 90 Days
2Comparator ArmProcedure-nasyam, नस्यम् (Procedure Reference: Saranghadhara Samhita,Madhyama khanda,chapter 9, Procedure details: Astamangala ghrita Nasya of 2drops will be instilled Intra-nasally once in a day in the Morning on an empty stomach.)
(1) Medicine Name: Astamangala ghrita, Reference: Saranghadhara Samhita,Madhyama khanda,chapter 9, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 90 Days
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  2.00 Year(s)
Gender  Both 
Details  Children with all types of cerebral palsy are aged between 1-2 years irrespective of gender, religion, or socio-economic status, children associated with cognitive impairment will be included. 
 
ExclusionCriteria 
Details  Cerebral palsy with severe form seizures, and intellectual disability will be excluded.
Cerebral palsy associated with other systemic illnesses, metabolic disorders, congenital malformations, and congenital myopathies will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of Panchabhautika ghrita nasya in the enhancement of cognitive functions in cerebral palsy.
2. To evaluate the efficacy of Astamangala ghritha nasya in the enhancement of cognitive
functions in cerebral palsy.
3. To evaluate the comparative efficacy of Panchabhautika ghritha nasya over the
Astamangala ghritha nasya in the enhancement of cognitive functions in cerebral palsy
 
Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days.
 
 
Secondary Outcome  
Outcome  TimePoints 
Milestones development leading to the achievement of functional and financial independence thereby burden on the families and society will be decreased and further which will enhance motor development too.  Clinical assessment will be done on both subjective and objective parameters at days 1 and 30 and follow-up at the 60th and 90th days. 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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/ Phase 4 
Date of First Enrollment (India)   02/12/2024 
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 Applicable 
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  

BRIEF REVIEW OF INTENDED WORK:

 INTRODUCTION:

Cerebral palsy (CP) is a nonprogressive neuromotor disorder that begins in childhood, often accompanied by disturbance of sensation, perception, cognition, communication, and behavior as well as making them physically, mentally handicapped, and socially apart.

The prevalence of the disease is ranging from 1-4/1000 live births with a male-to-female ratio of 1.4: 1, based on motor deficit, cerebral palsy is classified into spastic, hypotonic, dyskinetic and mixed cerebral palsy. Many cases of cerebral palsy are because of a combination of prenatal, perinatal, and post-natal factors.

Children with cerebral palsy exhibit symptoms like visual, hearing, speech, cognitive impairment, behavioral abnormality, drooling of saliva, feeding difficulties, communication difficulties, delay in reaching skill milestones, and lack in the attainment of higher mental functions which in turn leads to burden over the families and society.

Multisystem involvement in cerebral palsy makes its management symptomatic like speech therapy, occupational therapy, physiotherapy, medication, and surgery but still recovery is obscure and there is no availability of definitive treatment. Hence the parents of cerebral palsy children seek the support of another system of medicine like Ayurveda with a ray of hope.

In Ayurvedic literature analogs disease of cerebral palsy is not exactly mentioned but based on clinical features of the disease, it can be understood as a vata pradhan kaphanubandha vyadhi, which is manifested in various forms like sarvangavata, pakshaghata, ekangavata, pangu, khanja, kampavata, jadatwa, mukatwa due to siromarmabhighata. Etiologically it can be compared to shiromarmabhighata vata pradhan tridoshaja yapya vyadhi.

NEED FOR THE STUDY:

There is a need for study on the topic of cognitive enhancement in cerebral palsy because cognitive impairment is one of the biggest challenges for cerebral palsy survivors. Population registry data indicates that one in two children with CP has a cognitive impairment which elevates the risk for shortened life expectancy, comorbidities, and unemployment. 

About 30 to 50 % of children with cerebral palsy have some level of cognitive impairment. Children with severe cerebral palsy have a greater likelihood of having cognitive impairments .

Cognitive impairment can affect various domains such as attention, memory, language, perception, and executive functions, which are essential for learning, communication, and daily functioning. Cognitive impairment can also have negative impacts on the quality of life, mental health, and social integration of individuals with CP.

In Ayurvedic classics, there are many treatments mentioned in vatavyadhi like snehapana, swedana, abhyanga, mrudu samshodana, basti, nasya, parisheka, rasayana chikista.

Few researches were been done motor development but not on cognition alone. As nasya is one  of the effective procedure  among the above treatments since it is best treatment in shiroadhistana gata rogas hence the nasya has been taken for proving its cognitive enhancing effect in children with cerebral palsy.

                Among various drugs mentioned, Panchabhautika ghrita is selected as a trial drug to prove its        efficacy in enhancement of cognitive functions in cerebral palsy, as it is mentioned as panchendriya vivardhana and which will be compared with Asta Mangala ghritha. 
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