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.
(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
2
Comparator Arm
Procedure
-
nasyam, नसà¥à¤¯à¤®à¥
(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.