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CTRI Number  CTRI/2023/06/053628 [Registered on: 07/06/2023] Trial Registered Prospectively
Last Modified On: 05/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda Management Of Global Developmental Delay  
Scientific Title of Study   Clinical Study To Evaluate The Combined Effect Of Panchagavya Ghrita And Selected Ayurveda Treatment Modality As An Early Intervention In The Management Of Global Developmental Delay. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ANJITH C BABU 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan  
Address  Department Of Kaumara Bhritya Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan 573201
Thanniruhalla Hassan, 573201
Hassan
KARNATAKA
573201
India 
Phone  7996602710  
Fax    
Email  anjith.babu2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR VIJAYALAXMI MALLANNAVAR 
Designation  HOD, Associate professor 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan  
Address  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan
Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax    
Email  drvijayalaxmim@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  DR VIJAYALAXMI MALLANNAVAR 
Designation  HOD, Associate professor 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  
Address  Department Of Kaumarabhritya Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan
Thanniruhallla, Hassan,573201
Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax    
Email  drvijayalaxmim@sdmcahhassan.org  
 
Source of Monetary or Material Support  
sri dharmasthala manjunatheswara college of ayurveda and hospital 
 
Primary Sponsor  
Name  DR ANJITH C BABU 
Address  Department Of Kaumarabhritya Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan  
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 ANJITH C BABU  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital   Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan
Hassan
KARNATAKA 
7996602710

anjith.babu2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Ashtanga Hrudayam , Procedure details: Matra basti with Panchagavya Ghrita 10 Ml once a day immediately after food )
(1) Medicine Name: Panchagavya Ghrita , Reference: Bhaishajya Ratnavali , Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 20 Days
2Intervention ArmDrugClassical(1) Medicine Name: Panchagavya Ghrita, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 68 Days, anupAna/sahapAna: Yes(details: Honey ), Additional Information: -
3Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Ashtanga Hrudayam , Procedure details: Prathimarsha Nasya with Panchagavya Ghrita 2 drops twice a day )
(1) Medicine Name: Panachagavya Ghrita, Reference: Bhaishajya Ratnavali , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 68 Days
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  2.00 Year(s)
Gender  Both 
Details  1.Children between the age group of 6 months to 24 months irrespective gender fulfilling the
diagnostic criteria(DEVELOPMENTAL ASSESSMENT SCALE FOR INDIAN INFANTS DASII)
2.The children whose parents are willing to participate their child in the study and ready to
sign the consent form 
 
ExclusionCriteria 
Details  1. Children K/C/O Genetic & Chromosomal Abnormalities
2. Inborn Errors of Metabolism
3. All Diagnosed cases of congenital anomalies, protein energy malnutrition, rickets, 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvements in attainment of age-appropriate developmental milestones after intervention which were delayed during the initial assessment will be re- assessed using DASII ( Developmental Assessment Scale For Indian Infants)  0/90 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
General improvement in the quality of children with developmental delays is assessed during the course of intervention between & after the completion of the intervention using CDC Grading.  1/10/45/56/90 day 
 
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)   18/06/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Global developmental delay is one of the major issues of concern during the early childhood which is unnoticed due to lack of early screening. The prevalence of Global developmental delay in children under 2 years of age in India is 1.5 to 2.5 % among the live births1.Growth and development occurs simultaneously as a continuous process. Growth denotes the quantitative increase in the cell mass whereas Development is the gradual and systematic maturation of the nervous system. Maturity of the central nervous system, which is very much essential for a child to learn particular skill or to achieve a milestone. Growth being a quantitative parameter, growth retardations are identified at the earliest. Whereas normal developmental pattern is assessed using different developmental milestones, which are unnoticed due to lack of awareness and tendency to pretend it as normal even if there is lag or delay. Global developmental delay can be defined as the failure to attain the age-appropriate developmental milestones in 2 or more domains of development. Development depends on the functional maturation of the nervous system. As the brain matures, certain primitive reflexes are lost and specific milestones are achieved. If the primitive reflexes are persisting beyond the expected age of regression, it is an early indicator for developmental delay. Previous studies suggest that early screening, identification and early intervention has shown considerable improvement in the condition2. Stimulation through Ayurveda procedures as an early intervention is a new ray of hope for a healthy future among the kids with developmental delay. Masthishka abhighata can be considered as one among the cause for developmental delay. In Bhaishajyaratnavali in the context of Mastishkachayaapachaya, Panchagavya ghrita is mentioned as Rasayana3. Hence the present study is planned to evaluate the effect of administration of Panchagavya ghrita in various forms (Basthi, Pratimarsha nasya & oral intake) as an early intervention along with external stimulation procedures like Sarvanga abhyanga and Parisheka.

                                 

 
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