CTRI Number |
CTRI/2023/04/052105 [Registered on: 28/04/2023] Trial Registered Prospectively |
Last Modified On: |
19/10/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
To evaluate the IQ enhancing effect of Swarnprashana in Preschool Children |
Scientific Title of Study
|
Single arm open labelled trial to evaluate the efficacy of Swarnprashana in reference of ‘Maasat Param Medhavi’ in Preschool Children |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shruti |
Designation |
MD Scholar |
Affiliation |
Shri Krishna Ayurvedic College Kurukshetra |
Address |
Room Number 99, Department of Kaumarbhritya, Shri Krishna Government Ayurvedic College Kurukshetra Sector 8, Umari Road Kurukshetra, Haryana
Kurukshetra HARYANA 136118 India |
Phone |
7069156655 |
Fax |
|
Email |
bharmauriashrutti@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Amit Kataria |
Designation |
Associate Profesor |
Affiliation |
Shri Krishna Ayurvedic College Kurukshetra |
Address |
Room Number 99, Department of Kaumarbhritya, Shri Krishna Government Ayurvedic College Kurukshetra Sector 8, Umari Road Kurukshetra, Haryana
Kurukshetra HARYANA 136118 India |
Phone |
9034001230 |
Fax |
|
Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Amit Kataria |
Designation |
Associate Profesor |
Affiliation |
Shri Krishna Ayurvedic College Kurukshetra |
Address |
Room Number 99, Department of Kaumarbhritya, Shri Krishna Government Ayurvedic College Kurukshetra Sector 8, Umari Road Kurukshetra, Haryana
Kurukshetra HARYANA 136118 India |
Phone |
9034001230 |
Fax |
|
Email |
dramitkataria@rediffmail.com |
|
Source of Monetary or Material Support
|
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra, Haryana, 136118 |
|
Primary Sponsor
|
Name |
Shri Krishna Govt Ayurvedic College and Hospital Kurukshetra Haryana |
Address |
Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector-8, Kurukshetra, Haryana, 136118 |
Type of Sponsor |
Government 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 Amit Kataria |
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
Depatment of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College and Hospital, Umri road, Sector-8, Kurukshetra, Haryana, 136118
Kurukshetra
HARYANA Kurukshetra HARYANA |
9034001230
dramitkataria@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Shri Krishna Ayush University Kurukshetra |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Appropriately healthy preschool children |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Swarnaprashna, Reference: Kashypa Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Dose of of Swarnaprashna will be calculated by using to the Clarks formula according to dose of swarna bhashma. The basis of swarna bhasham dose will Rastangini |
|
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
6.00 Year(s) |
Gender |
Female |
Details |
1.Healthy children of either sex belonging to age group 3 to 6 years.
2.Parents willing their children to participate in the trial.
|
|
ExclusionCriteria |
Details |
1.Age below 3 years and above 6 years.
2.All congenital anomalies and all hereditary diseases.
3.Children with acute and chronic systemic infectious diseases, metabolic disorders, learning disability, Mental Retardation, Cerebral palsy.
4.All the contraindications of lehana mentioned in Kashyapa Samhita like - Jwara, Agnimandya, Atisara etc.
5. Subject having known history of allergy from trial drug ingredients.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Intelligence Quotient by Binet Kamat Test adaptation of the Stanford -Binet Test |
0 day and 45th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improvement in the general growth parameters of healthy pre-school going children viz. height, weight, MUAC, head circumference, chest circumference and BMI. |
0 day and 45th day |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
03/07/2023 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
29/01/2024 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
v Swarnaprashana prepared
in this study demonstrates a range of beneficial properties including antioxidant,
anti-inflammatory, antimicrobial, immunomodulatory, nootropic properties.
These
effects contribute to promote immunity, growth and development, ultimately
enhancing
overall
health in children.
v All
the ingredients of this herbomineral prepration Swarnaprashana
exhibits
nootropic effect and hence lead to improvement in IQ scores of the preschool
children when administered for continuous one month duration in the present
study and further stating the fact of “Maasat Param Medhavi†as
described in the ancient text by Acharya Kashyapa.
v Total
effect of therapy showed varied results on IQ score improvement data among
participants.
v Moderate
Improvement: The majority of participants
experienced moderate gains, with 42 individuals increasing their IQ scores by
1-2 points.
v Significant
Improvement: A smaller group of 7 participants achieved significant
improvements of more than 3 points, indicating substantial cognitive
enhancement.
v Mild
Improvement: Mild improvement was noted in 7 cases.
v Marked
Improvement: Four participants demonstrated marked improvement, with increases
of 2-3 points.
v Interestingly,
none of the participants reported no improvement at all.
v There
was a statistically significant increase in haemoglobin levels from 11.35 ±
1.07 gm% to 11.88 ± 1.09 gm% (p < 0.0001). This indicates a highly
significant improvement in hemoglobin levels post-trial. |