FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/079975 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of developmental delay in 6-24months children  
Scientific Title of Study   Clinical study to evaluate the efficacy of samvardhana ghrita through various routes of administration as an early intervention in the management of developmental delay  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja HP 
Designation  Post graduate scholar  
Affiliation  SDM college of Ayurveda and hospital, Hassan 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Hassan KARNATAKA INDIA
-
Hassan
KARNATAKA
573201
India 
Phone  7829381507  
Fax  -  
Email  poojapartha22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijayalaxmi Mallannavar  
Designation  Professor  
Affiliation  SDM college of Ayurveda and hospital, Hassan 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Hassan KARNATAKA INDIA
-
Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax  -  
Email  abtittu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pooja HP 
Designation  Post graduate scholar  
Affiliation  SDM college of Ayurveda and hospital, Hassan 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Hassan KARNATAKA INDIA
-
Hassan
KARNATAKA
573201
India 
Phone  7829381507  
Fax  -  
Email  poojapartha22@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan Thanniruhalla BM Road Hassan, Karnataka, India, 573201 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And HospitalHassan 
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan Thanniruhalla BM Road Hassan, Karnataka, India, 573201 
Type of Sponsor  Private medical college 
 
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 HP  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Thanniruhalla BM Road Hassan  Out Patient Department of Kaumarabhritya Room No 16 and 18 Hassan Karnataka
Hassan
KARNATAKA 
7829381507
-
poojapartha22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe Sri Dharmasthala Manjunatheshwara 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:G968||Other specified disorders of central nervous system. Ayurveda Condition: BALA-PAKSHAGHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Samvardhana ghrita, Reference: Kashyapa samhitha, Route: Rectal, Dosage Form: Ghrita, Dose: 8(ml), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  Children aged between 6 months and 24 months, regardless of gender, who meet the diagnostic
criteria
Children whose parents are willing to enroll them in the study and are prepared to sign the consent form 
 
ExclusionCriteria 
Details  Children who are K/C/O Genetic & Chromosomal Abnormalities
Children who are diagnosed with cases of congenital anomalies protein-energy malnutrition rickets and uncontrolled seizures 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The following criteria will be assessed
Motor age
Mental age
And milestones attained appropriate for age  
Day 0
Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
The parameters assessed for the child
Motor age
Mental age
Developmental milestones
 
Day 0
Day 90 
 
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)   18/02/2025 
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)   Open to Recruitment 
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  
Developmental delay manifests as failure to reach age appropriate milestones in multiple domains 
Persistence of primitive reflexes beyond expected regression ages indicates potential delay. Early
screening and intervention have proven effective, with Ayurvedic methods offering promising
prospects. Masthishka abhighata, a possible contributor to developmental delay is addressed in
Ayurvedic texts. Certain factors influencing on growth and development of the child can be assessed to
the earliest i.e., from the very next moment after conception.The term samvardhana is found in kashyapa Samhita Lehanadhyayam while explaining Samvardhana
ghrita , different lehya formulations for developmental disorders like Mukatha, Panguta, Ashruthi,
etc.Samvardhana is a special characteristic feature of children, which distinguishes them from an adult.
Not all faculties develop at a time in the infant. The child acquires different skills and talents at different
periods of growth and development. Thus, failure to achieve different milestones could grossly be
termed as samvardhana vikaras which at earliest to be intervened and proper care to be taken. Thus
using of certain ayurvedic treatment like pratimarsha nasya, matra basti modalities will be useful in
achieving and attaining milestone domains at the earliest
 
Close