| CTRI Number |
CTRI/2025/08/093409 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to check how well Baljeevan Syrup works in boosting immunity in children between 4 and 9 years |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Baljeevan Syrup as an Immunity Booster in Children aged 4-9 years old- An Open labelled, Double arm, Multi centric, Comparative, Post-Marketing Survillence Study (Phase IV) Clinical Study |
| 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 Kalpana Dhuri |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Deemed to be University, School of Ayurveda, Nerul-Navi Mumbai |
| Address |
A1- Ground Floor, Amba Apt, Pandurang Naik Marg, Shivaji Park Road no-5, Near Dinshaws ice cream parlor, Mahim-Mumbai
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9321835616 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Dhuri |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Deemed to be University, School of Ayurveda, Nerul-Navi Mumbai |
| Address |
A1- Ground Floor, Amba Apt, Pandurang Naik Marg, Shivaji Park Road no-5, Near Dinshaws ice cream parlor, Mahim-Mumbai
MAHARASHTRA
400016
India |
| Phone |
9321835616 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Dhuri |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Deemed to be University, School of Ayurveda, Nerul-Navi Mumbai |
| Address |
A1- Ground Floor, Amba Apt, Pandurang Naik Marg, Shivaji Park Road no-5, Near Dinshaws ice cream parlor, Mahim-Mumbai
MAHARASHTRA
400016
India |
| Phone |
9321835616 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rashtriya Shikshan Mandals Research Institute of Health Sciences and Management, Pune |
|
|
Primary Sponsor
|
| Name |
Rashtriya Shikshan Mandals Research Institute of Health Sciences and Management Pune |
| Address |
25,Karve Road,Khilarewadi, Deccan Gymkhana, Pune-411004 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalpana Dhuri |
D Y Patil Deemed to be University, School of Ayurveda, Nerul |
OPD no-7, Kaumarbhrutya OPD D Y Patil School of Ayurveda, Sector-7, Nerul- Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9321835616
dhurikalpana34@gmail.com |
| Dr Rachna Mohite |
Sai Child Care Hospital |
4/5, Vijay Marg, Opp. Shreeyash Hospital, Sector-19, New Panvel East, Panvel
Raigarh
MAHARASHTRA |
9769123024
rachnashanbhag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Standard of Care (SoC) | Participants in the comparator arm will receive Standard of Care (SoC) for immunity support, without Baljeevan Syrup. SOC will include age appropriate nutritional counselling and symptomatic treatment as per standard pediatric practice. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Syrup Baljeevan, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 4 to 9 years old.
2.Clinically diagnosed with recurrent respiratory allergic disorders.
3. Parents/guardians willing to provide written informed consent for participation.
|
|
| ExclusionCriteria |
| Details |
1. Children below 4 years or above 9 years of age.
2.Known cases of congenital heart disease, chronic kidney disease, diabetes, or tuberculosis.
3.Known cases of systemic disorders.
4.Known cases of immunodeficiency disorders.
5.Currently undergoing steroid treatment or immunosuppressive therapy.
6.Participation in any other clinical study within 3 months prior to screening for the present study.
7.Other conditions, which in the opinion of the investigators, render the patient unsuitable for enrolment or could interfere with adherence to the study protocol.
8.Inability or unwillingness of the parent/guardian to adhere to the follow-up schedule or instructions.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in frequency of respiratory allergic episodes.
|
Baseline, end of 6th month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Changes in immunological markers like IgE, IL6, IL10. |
Baseline, end of 6th month |
| 2.Improvement in general Health parameters. |
Every Visit |
| 3.Safety and tolerability of Baljeevan Syrup. |
Every Visit |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="0"
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
|
An open-labelled, double-arm, multicentric, Phase IV post- marketing surveillance study to assess the efficacy and safety of Baljeevan Syrup as an Immunity booster in children aged 4-9 years. The trial compares Baljeevan Syrup with standard care in improving immune status, reducing frequency and severity of infections, and ensuring safety in the pediatric population. |