| CTRI Number |
CTRI/2024/12/078615 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Herbal] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study on Vasu Suvarnaprashan Drops in improving immunity in children. |
|
Scientific Title of Study
|
A clinical study to assess the efficacy & safety of Vasu Suvarnaprashan Drops in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/035 Version: 1.00; 30 September 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamlesh Satras |
| Designation |
Principal Investigator |
| Affiliation |
Sangvi Multispeciality Hospital Pvt. Ltd |
| Address |
Survey No 71/1/2/189 City Survey No 2387 Shirode Road
Vinayak Nagar Ln. No. 2 near Krushna Chowk, Krishna Nagar
New Sangavi
Pune
MAHARASHTRA
411027
India |
| Phone |
9975212576 |
| Fax |
- |
| Email |
drkamlesh.sangvihospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hardik Soni |
| Designation |
Asst. General Manager (R & D) |
| Affiliation |
Vasu Healthcare Pvt Ltd |
| Address |
967 4, GIDC, Opposite ERDA, Makarpura Vadodara
Vadodara
GUJARAT
390010
India |
| Phone |
9428692240 |
| Fax |
- |
| Email |
hsoni@vasuresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hardik Soni |
| Designation |
Asst. General Manager (R & D) |
| Affiliation |
Vasu Healthcare Pvt Ltd |
| Address |
967 4, GIDC, Opposite ERDA, Makarpura Vadodara
Vadodara
GUJARAT
390010
India |
| Phone |
9428692240 |
| Fax |
- |
| Email |
hsoni@vasuresearch.com |
|
|
Source of Monetary or Material Support
|
| Vasu Healthcare Pvt. Ltd. 967 4 GIDC Opposite ERDA, Makarpura Vadodara Gujarat 390010 |
|
|
Primary Sponsor
|
| Name |
Vasu Healthcare Pvt Ltd |
| Address |
967 4 GIDC Opposite ERDA Makarpura Vadodara Gujarat
390010
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Kamlesh Satras |
Sangvi Multispeciality Hospital Pvt Ltd |
Survey No 71/1/2/189, City Survey No 2387, Shirode Road,
Vinayak Nagar Ln. No. 2 near Krushna Chowk, Krishna Nagar
New Sangavi
Pune
MAHARASHTRA |
9975212576
-
drkamlesh.sangvihospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vasu Swarnaprashan
Drops |
3 drops of Vasu Suvarnaprashan drops daily for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children Aged 0-16 years inclusive (both gender) Participants will be equally distributed to age range from 0-5 years (Both inclusive) 5 plus to 10 years (Both inclusive) and 10 plus to 16 years (Both inclusive) that is 10 participants in each category.
2.Parents or guardians understand and are willing, able and likely to comply with all study procedures and restrictions. |
|
| ExclusionCriteria |
| Details |
1.Participant has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product.
2.The participant has an ongoing illness requiring medical management.
3.The participant has a gastrointestinal infection and or acute diarrhea at the time of inclusion in the study.
4.The participant is currently taking medication that could affect the absorption or metabolism of the study product or the weight of the child.
5.The participant is diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes congenital abnormalities of the respiratory tract congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma (As per history and or the medical records).
6.Any other condition that could interfere with the study outcomes as per the discretion of the investigator will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in physical growth parameters
•Anthropometric parameters like height, body weight upper arm & chest circumference, and BMI. |
screening, day 30, day 60, and day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Effect on Immunological parameters like-
•Serum Immunoglobulin A, G levels
•Changes in frequency severity and recovery of URTI
2.cardiorespiratory fitness- VO2 and Pre-school adapted 20m Shuttle run test (PREFIT).
3.Learning ability memory and concentration- Questionnaire for Evaluation of Development and Behaviour (Parent version)- Attention and concentration memory reading writing arithmetic learning new things and applying knowledge in school domain scores will be analyzed.
4.Quality of sleep- Pittsburgh Sleep Quality Index (PSQI) will be assessed.
5.Change in appetite score using the child eating behaviour questionnaire (CEBQ).
6.Parent or Guardian reported an overall improvement in child growth and development after treatment on the 5-point Likert scale.
|
screening and end of the study
screening, day 30, day 60, and day 90.
screening and day 90 (Only for groups B and C)
screening and day 90
screening and day 90
screening, day 30, day 60, and day 90
day 90
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
03/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Suvarnaprashan drops, containing traditional Ayurvedic herbs like Shankhpushpi, Brahmi, Vacha, Honey, and Swarna Bhasma, have been historically used to promote cognitive function, immunity, growth, cardiorespiratory fitness, appetite, and sleep in children. Despite their historical usage, and demonstrated individual benefits in preliminary studies, modern scientific validation of these formulations in paediatric populations is limited, particularly in clinical safety and efficacy. Given the critical physical and cognitive development in children aged 0 to 16 years, it is essential to provide evidence-based supplements that support optimal growth, development, and immune function. This open-label clinical trial will provide valuable data on the efficacy of Vasu Suvarnaprashan Drops in promoting growth, development, cardiorespiratory fitness, learning, cognition, concentration, and immune health while ensuring their safety for long-term use. This study aims to fill the current gap in evidence, offering insights that could inform both clinical practice and the broader acceptance of traditional Ayurvedic interventions in the pediatric population. |