| CTRI Number |
CTRI/2025/02/080066 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to Assess the Safety and Benefits of JB Bal Vita for Improving Childrens Health. |
|
Scientific Title of Study
|
An Open-Label, Single-Center, Single-Arm Clinical Study to Evaluate the Safety and Efficacy of JB BAL Vita (Bal Poshak Rasayana) In Enhancing Children’s Health. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CTSRS/2423 Version No. 2.0 Dated 19/Dec/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JamunaBA |
| Designation |
Principal Investigator |
| Affiliation |
RVS Ayurvedic Medical College Hospital and Research Centre |
| Address |
Rom No. 201, 1st floor, RVS Ayurvedic Medical College, Hospital and Research Centre, Srigandhadakavalu, Vishwaneedam Post,
Outer Ring Road,Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
pi.clinicaltrial@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
9739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Ms Mamatha B Gokavi |
| Designation |
Project Manager |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
mamatha@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmaceuticals Pvt. Ltd. Paprola Tehsil, Baijnath, Himachal Pradesh 176115 |
|
|
Primary Sponsor
|
| Name |
Baijnath Pharmaceuticals Pvt. Ltd |
| Address |
Paprola Tehsil, Baijnath, Himachal Pradesh 176115 |
| 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 JamunaBA |
RVS Ayurvedic Medical College, Hospital and Research Centre |
RVS Ayurvedic Medical College, Hospital and Research Centre,
Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road,
Bangalore
Bangalore
KARNATAKA |
6364898825
pi.clinicaltrial@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R633||Feeding difficulties. Ayurveda Condition: AGNIVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: JB Bal Vita, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 180 Days, anupAna/sahapAna: No, Additional Information: -
The Investigational Product (IP) in this study is JB Bal Vita (Bal Poshak Rasayana). Each participant will receive a daily dose of 1 sachet, which should be consumed orally. The treatment will continue for a period of 180 days for each participant throughout the study. |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: Children aged 3 to 6 years, inclusive.
2.Parental Consent: Consent must be provided by the mother or legal guardian through a signed informed consent form. The parent/guardian should agree to complete study activities and attend follow-up visits.
3.Willingness to Comply: The parent/legal guardian must agree to comply with study procedures, including scheduled visits and reporting on health metrics.
4.Nutritional Concerns: The child must exhibit poor appetite or inadequate nutritional intake, evidenced by symptoms such as weakness, emaciation, or refusal to eat.
5.Study Exclusivity: The child must not participate in any other clinical studies during their involvement in this study. |
|
| ExclusionCriteria |
| Details |
1. Chronic Illness or Genetic Disorders: Children with significant chronic illnesses (e.g., heartdisease, chronic respiratory conditions) or genetic disorders that could impact growthordevelopment are excluded. 2. Allergies: Any known allergy or hypersensitivity to the ingredients in JB Bal Vita (Bal PoshakRasayana). 3. Investigator’s Discretion: Children deemed unsuitable for the study by the investigatororphysician due to medical or behavioral
4. Medication Use: Children using medications or supplements that may interfere withthestudyproduct or affect growth and nutritional outcomes. 5. Lack of Consent: Children whose parents or legal guardians are unwilling or unable toprovideconsent or adhere to study requirements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Growth Metrics:
Changes in BMI from baseline to end of study to assess physical growth. Assessment of age-appropriate developmental milestones to evaluate physical and cognitive development.
Appetite and Nutritional Status:
Changes in appetite based on caregiver reports using structured questionnaires. Assessment of food intake through caregiver feedback on meal frequency and portion size. Overall nutritional status assessed through caregiver observations and anthropometric measures. |
Day 0, Day 30, Day 60, Day 90 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Health Perception Questionnaire:
• Parental/Caregiver Perception: Collection of data from parents or caregivers on perceived
health improvements, such as energy levels, immune health (reduction in frequency of minor
illnesses), & general well-being of the child.
Safety Endpoints:
• Adverse Events (AEs): Monitoring & recording any adverse events throughout the study
to ensure the safety profile of JB Bal Vita in children aged 3 to 6 years.
• Tolerability: Assessment of any side effects or discomfort reported by parents or caregivers
to evaluate overall tolerability.
|
Day 0, Day 30, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Brief Summary: Childhood is a critical period for growth and development, where proper nutrition plays a vital role in a child’s health. However, many children face challenges such as poor appetite and undernutrition, leading to growth delays and an increased risk of infections. JB Bal Vita (Bal Poshak Rasayana) is a nutritional supplement designed to support children’s overall health, growth, and immune function. Based on traditional Ayurvedic principles, it includes ingredients that may enhance appetite, support digestion, and improve nutritional status. The product is aimed at children aged 3 to 6 years and is administered as a daily sachet. This study will evaluate the safety and efficacy of JB Bal Vita in improving health markers like growth, appetite, and nutrition in children with poor dietary intake and general weakness. Purpose of the Study: The purpose of this clinical study is to confirm the safety and effectiveness of JB Bal Vita in improving health markers such as growth, appetite, and overall nutritional status in children. By conducting this clinical trial, we aim to provide empirical evidence to support the product’s claims and ensure its adherence to modern clinical standards. This study will help establish JB Bal Vita as a safe and effective nutritional supplement, offering a natural solution for improving children’s health and addressing issues related to poor appetite and undernutrition. |