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CTRI Number  CTRI/2023/07/055658 [Registered on: 25/07/2023] Trial Registered Prospectively
Last Modified On: 22/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the efficiency of panchabhautika ghrita nasya over panchabhautika taila nasya for enhancement of cognitive function in cerebral palsy 
Scientific Title of Study   A Controlled Clinical Study To Evaluate The Efficacy of Panchabhautika Ghrita Nasya Over Panchabhautika Taila Nasya For Enhancement of Cognitive Functions in Cerebral Palsy in Children  
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja nagappa Kuchanur 
Designation  PG scholar 
Affiliation  Shree jagadguru Gavisiddheshwara ayurvedic medical college and hospital koppal 
Address  Shree jagadguru Gavisiddheshwara ayurvedic medical college and hospital Room No 13 Kaumarabhritya OPD koppal
Department of Kaumarabhritya Room No 13 Koppal
Koppal
KARNATAKA
583231
India 
Phone  8792301108  
Fax    
Email  poojakuchanur5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radhika Injamuri 
Designation  Associate Professor,Dept.of Kaumarabhritya 
Affiliation  Shree Jagadguru Gavisiddeshwara ayurvedic Medical College and Hospital Koppal 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital ,Room No 13 Kaumarabhritya OPD ,Koppal
Department of Kaumarabhritya Room No 13 Koppal
Koppal
KARNATAKA
583231
India 
Phone  9108304745  
Fax    
Email  raadhika17@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Radhika Injamuri 
Designation  Associate Professor,Dept.of Kaumarabhritya 
Affiliation  Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital ,Room No 13 Kaumarabhritya OPD ,Koppal
Department of Kaumarabhritya Room No 13 Koppal
Koppal
KARNATAKA
583231
India 
Phone  9108304745  
Fax    
Email  raadhika17@outlook.com  
 
Source of Monetary or Material Support  
Shee Jagadguru Gavisiddeshwara Ayurvedic Medical College Koppal 
 
Primary Sponsor  
Name  Dr Pooja Nagappa Kuchanur 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital ,Koppal,Karanataka 
Type of Sponsor  Other [self sponsoring] 
 
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 Pooja Nagappa Kuchanur  Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Koppal karnataka  Department of Kaumarabhritya OPD No 13 Koppal
Koppal
KARNATAKA 		 8792301108

poojakuchanur5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Istitutional Ethical Committee clearance Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital Koppal   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
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Kashyapa Samhita, Procedure details: Urdwajatru Bhaga Abhyanga with Panchabhautika Taila Swedana Nasya with Panchabhautika Taila Kavala or mridu Dhumapana)
(1) Medicine Name: Panchabhautika Taila, Reference: Kasyapa Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 7 Weeks
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Kashyapa Samhita, Procedure details: Urdwajatrubhaga Abhyanga with Panchabhautika Ghrita Swedana Nasya with Panchabhautika Ghrita kavala or mild Dhumapana )
(1) Medicine Name: Panchabhautika Ghrita, Reference: Kashyapa Samhita, Route: Nasal, Dosage Form: Ghrita, Dose: 2(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  children with cerebral palsy aged between 2 – 16 years. Irrespective of gender, religion, socio economical status and types of the cerebral palsy. And cerebral palsy with moderate to severe intellectual disability will be included. 
 
ExclusionCriteria 
Details  cerebral Palsy associated with seizers systemic illness, metabolic disorder ,congenital malformation ,congenital myopathies will be excluded. If progressive neuro degenerative disorder 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 
To assess cognitive function.  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess gross motor function.  1st day- before treatment
7th day- first cycle of treatment
28th day- second cycle of treatment
42nd day- after treatment follow up  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/08/2023 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poojakuchanur5@gmail.com].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 01-11-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Children with cerebral palsy exhibits symptoms like visual, hearing, speech, cognitive, behavioral abnormality, drooling of saliva, feeding difficulties, communication difficulties, delay in reaching skill milestones1 and lacking in attainment of higher mental functions which in turn leads to burden over the families and society  As nasya is one among the above procedures, the present study is selected. In which panchabhautika ghrita and panchabhautika taila are taken to prove their efficacy in enhancement of cognitive functions in cerebral palsy, as it is mentioned as panchendriya vivardhana by Acharya Kashyapa. As per classical reference panchabhautika taila nasya and ghrita nasya where it is said to be taken in both forms6. Hence the present study is planned to compare the efficacy of both panchabhautika taila and panchabhautika ghrita nasya in enhancement of cognitive functions in cerebral palsy.

 
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