| CTRI Number |
CTRI/2025/03/082687 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of SwarnaPrashana on developmental delay children of below 1 years of age |
|
Scientific Title of Study
|
Comparative study of Swarnaprashana wrt madhu & ghrita . A single blind placebo control clinical trial |
| 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 Rupesh Agrawal |
| Designation |
Post Graduate Student |
| Affiliation |
GOPABANDHU AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
| Address |
Post Graduate Department Of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri
Post Graduate Department Of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri
Puri
ORISSA
752002
India |
| Phone |
9178801549 |
| Fax |
|
| Email |
rupeshagrawal046@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangita Prusty |
| Designation |
Reader & HOD |
| Affiliation |
GOPABANDHU AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
| Address |
Post Graduate Department Of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri
POST GRADUATE DEPARTMENT OF KAUMARBHRITYA GOPABANDHU AYURVEDA MAHAVIDYALAYA VIP ROAD Puri
Puri
ORISSA
752002
India |
| Phone |
7008329522 |
| Fax |
|
| Email |
prustydrsangita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangita Prusty |
| Designation |
Reader & HOD |
| Affiliation |
GOPABANDHU AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
| Address |
Post Graduate Department Of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri
POST GRADUATE DEPARTMENT OF KAUMARBHRITYA GOPABANDHU AYURVEDA MAHAVIDYALAYA VIP ROAD Puri
Puri
ORISSA
752002
India |
| Phone |
7008329522 |
| Fax |
|
| Email |
prustydrsangita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri
pin-752002 state-odisha india
|
|
|
Primary Sponsor
|
| Name |
Dr Rupesh Agrawal |
| Address |
Post Graduate Department Of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri 752002 odisha india |
| Type of Sponsor |
Other [Self] |
|
|
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 Sangita Prusty |
Gopabandhu Ayurveda Mahavidyalaya |
Post Graduate Department Of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya Vip Road Puri pin-752002 odisha india
Puri
ORISSA |
7008329522
prustydrsangita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE GOPABANDHU AYURVEDA MAHAVIDYALAYA AND VIP ROAD PURI 752002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INFANT
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: madhu and ghrita, Reference: kashyap sutra sthana-18/25-28, Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 5(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: swarnaprashana, Reference: kashyap samhita sutra sthana--18/25-28, Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 5(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1) Full term infants.
2) Patients suffering from frequent cold
3) Developmental Delay Cases Without CP ADHD Muscular Dystrophy And Other systemic and grave diseases |
|
| ExclusionCriteria |
| Details |
1) Children above 1 years of age.
2)Already undergoing Swarnaprashana.
3)Suffering fro infectious Heriditary and Systemic diseases.
4)Suffering fro Grave diseases.
5)Not willing to take Swarnaprashana. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| physical and mental growth child |
1 month(30 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in the developmental delay cases frequency of common diseases reduces & body immunity increases |
1 month(30days) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/03/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Children suffers from many diseases and delayed milestone development so need has felt to developed certain ayurvedic formulations for the maintenance of health of a child and proper milestone development by which we can create future generation more talented . So keeping all the facts in mind i have taken it for study |