| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 |