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CTRI Number  CTRI/2024/12/078568 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Jeevaneeya Ghee Nasal drops and Pressure point therapy in special children  
Scientific Title of Study   Randomized comparative clinical study to evaluate the efficacy of Jeevaneeya Ghrita Pratimarsha Nasya and Marma Chikitsa in children with Autism with special reference to social relationship and emotional responsiveness 
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 N Logeshwaran  
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  Departnment of Kaumarabhritya, Room no 09 Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  7904430853  
Fax    
Email  drnlogeshwaran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudheer B R 
Designation  Preofessor and HOD 
Affiliation  Sri Sri College of Ayurvedic Science and Research  
Address  Departnment of Kaumarabhritya, Room no 09 Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  9900175777  
Fax    
Email  sudheerbrao@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr N Logeshwaran 
Designation  PG Scholar 
Affiliation  ri Sri College of Ayurvedic Science and Research  
Address  Departnment of Kaumarabhritya, Room no 09 Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore

Bangalore
KARNATAKA
560082
India 
Phone  7904430853  
Fax    
Email  drnlogeshwaran@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research, Bangalore,Karnataka,India Pincode:560082 
 
Primary Sponsor  
Name  Dr N Logeshwaran 
Address  Departnment of Kaumarabhritya, Room no 09 Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore  
Type of Sponsor  Other [SELF] 
 
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 N Logeshwaran  Sri Sri College Of Ayurvedic Science and Research Hospital, Bangalore  Departnment of Kaumarabhritya, Room no 09 Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore
Bangalore
KARNATAKA 		 7904430853

drnlogeshwaran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Charaka samhita siddhi sthana chapter 9, Procedure details: Procedure details: The medicine will be made luke warm by placing it in a vessel containing hot water. The child should be made to lie straight in supine position, legs should be slightly raised & the head should be slightly extended up to 45 degree. Later, tip of nose is drawn upward by the Vama Pradeshini (left index finger) and with the Dakshina Hasta (right hand), 2 Bindu (drops) of lukewarm medicament is instilled into both the nostrils one after the other, keeping one nostril closed while the other is instilled with medicine and marma chikitsa will be done.)
(1) Medicine Name: Jeevaniya Ghrita, Reference: Ashtanga Hridaya Uttara Sthana Chapter 6 verse 44, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 60 Days
2Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Charaka samhita siddhi sthana chapter 9, Procedure details: The medicine will be made luke warm by placing it in a vessel containing hot water. The child should be made to lie straight in supine position, legs should be slightly raised & the head should be slightly extended up to 45 degree. Later, tip of nose is drawn upward by the Vama Pradeshini (left index finger) and with the Dakshina Hasta (right hand), 2 Bindu (drops) of lukewarm medicament is instilled into both the nostrils one after the other, keeping one nostril closed while the other is instilled with medicine.)
(1) Medicine Name: Jeevaniya Ghrita, Reference: Ashtanga Hridaya Uttara Sthana Chapter 6, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 60 Days
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children in the age group of 3 years – 8 years
2.Children diagnosed with mild to moderate Autism , irrespective of their gender, religion and socio-economic status will be included.
3.Children in whom parents are willing to sign the written consent form will be included. 
 
ExclusionCriteria 
Details  1.Children who are known case of ADHD and the other syndromes associated with ASD such as Asperger’s syndrome, Rett syndrome, childhood disintegrative disorder, Kanner’s syndrome and Anxiety disorder, Mental Retardation, will be excluded.
2.Children with other chronic systemic illnesses 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 social relationship and emotional responsiveness in children with Autism assessed based on Indian Scale for Assessment of Autism (ISAA)
 		 0-30-60-90 th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Generation of in – depth analysed data on the different aspects of the disease.
2.Generation of data on possible unexpected drug reaction or of Marma Chikitsa.
 		 1st assessment on 0th day
2nd assessment on 30th day
3rd assessment on 60th day
4th assessment on 90th day
 
 
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)   30/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/12/2024 
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  
•Autism is a developmental disability caused by hypoconnectivity in the brain . People with ASD experience myriad of  difficulties in communicating with others or understanding social cues.
•Autism is characterized by difficulties in initiating social interaction and communication; restricted interests and repetitive behavior which poses a great challenge to individuals and to societies not just in early ages but across lifespan due to its pervasive nature. 
•Autism is the third most common developmental disorder. According to WHO, it is estimated that worldwide about 1 in 100 children has autism. In 2021 About 1 to 1.5 % of children aged 2 to 9 years are diagnosed with ASD, In 2023 about 18 million people in India are diagnosed with Autism. 
•Social deficits in autism include initiating interaction, responding to initiations, maintaining eye contact etc. these social deficits make it difficult for the child to develop personal relationships, peer rejection, anxiety, depression etc.
•Along with social deficits they also face difficulties in emotional regulation and processing leading to difficulty in identifying and attributing emotions, lack of pragmatic understanding etc.
•Autism in Ayurveda is an Anuktha Vyadhi and it can be nearly considered under a state of Unmada spectrum conduct disorder where there is defective endowment called pervasive disorder or Jadatwa. This is dominated by complete Buddhi Nirodha by Tamoguna.
•Along with Manasika Doshas, Shareerika Doshas also play an important role in stabilizing the Manas and Indriyas. The balanced state of Pitta and Vata helps to control emotional imbalances and promotes wise social interaction. Jeevaneeya Ghrita mentioned in Pittaja Unmada is one such Yoga which promotes above benefits by its Madhura , Tikta, Snigdha , Brimhana , Ojasya properties.
•Administration of Jeevaneeya Ghrita in the form of Pratimarsha Nasya is more beneficial, as Nasa (nasal cavity) is the nearest route for Shiras, the drug administered through Nasa will have a quicker effect on Shirohridaya and helps in reducing Pittavataja Lakshanas of Unmada.
•There are certain special points called as Marma Sthanas in the body which control the endocrinal , neuromuscular activities of the surrounding areas . Stimulation of these Marmas facilitates the removal of Srotorodha and proper flow of energy resulting in cure of diseases. Marma Chikitsa is an emerging branch of supportive therapy which focuses on systematic stimulation of Marmas for achieving therapeutic effect.
•Clinically, performance of Marma Chikitsa on Sthapani Marma (Thilartha kalam) has shown improvement in clinical features of autism, but its effectiveness is not validated systematically.
•There is a strong need for intervention on developing the social skills and regulation of emotional states in children with ASD as they have life long implications and are extremely difficult to learn.
•Thus the current study aims at improving the emotional responsiveness and social relationship of children with autism by the use of Pittahara Brimhana Ghrita Pratimarsha Nasya and Marma Chikitsa and validating the findings on a standard scale.
 
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