| CTRI Number |
CTRI/2026/01/101240 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on ayurvedic formulation balaposhaka granules for improving growth in children with poor weight gain |
|
Scientific Title of Study
|
Effect of balaposhaka granules in the management of failure to thrive in children - an open label, single arm, interventional 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 Dipali Rakeshbhai Agrawal |
| Designation |
P G Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8980852555 |
| Fax |
|
| Email |
dipaliagrawal1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rutu Patel |
| Designation |
Professor and HOD Department of Kaumarbhritya |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9428600605 |
| Fax |
|
| Email |
drrutu84@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali Rakeshbhai Agrawal |
| Designation |
P G Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad
Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8980852555 |
| Fax |
|
| Email |
dipaliagrawal1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar ayurveda teaching pharmacy of J S Ayurveda mahavidyalaya and P D Patel Ayurvedic hospital, Nadiad-387001,Gujarat, India |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
Department of kaumarbhritya, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001 |
| Type of Sponsor |
Private 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 Dipali Rakeshbhai Agrawal |
P D Patel Ayurveda hospital |
Department of kaumarbhritya, J S Ayurveda Mahavidyalaya, College road, Nadiad-387001, Kheda, Gujarat
Kheda
GUJARAT |
8980852555
dipaliagrawal1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-Maganbhai adenwala mahagujarat university Nadiad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R625||Other and unspecified lack of expected normal physiological development in childhood. Ayurveda Condition: KARSY, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Balaposhaka Granules, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1 Children belonging to age group 2 to 8 years irrespective of religion, gender and socio-economic status.
2 Children diagnosed with Failure to thrive below 3rd and 5th percentile of weight-for- age according to WHO growth chart.
3 Children with normal cognitive milestone for age to ensure proper feeding and compliance.
Children who are medically stable with no acute illness at the time of enrollment.
|
|
| ExclusionCriteria |
| Details |
1 Age below 2 years and above 8 years.
2 Children whose weight is above 5th percentile based on weight-for-age according to WHO growth chart.
3 Children having systemic, neurological, endocrinal, genetic disorders, congenital anomalies and anatomical defects.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in weight for age percentile as per WHO growth standard and overall general well being in children aged 2 to 8 years with failure to thrive after 4 weeks of treatment with balaposhaka granules |
Baseline and after 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Failure to thrive is a common pediatric growth disorder characterized by inadequate weight gain in children, leading to long-term physical and developmental consequences if untreated. Ayurveda emphasizes the role of proper nutrition, digestion, and strength-promoting formulation in ensuring healthy growth during childhood. Balaposhaka granules is an ayurvedic formulation traditionally made to enhance digestion, nourishment, and immunity in children. This study is an open label, single arm interventional clinical trial planned to evaluate the effect of balaposhaka granules in children aged 2 to 8 years diagnosed with failure to thrive based on WHO weight fpr age standards. A total of 40 participants will receive age appropriate dose of balaposhaka granules orally twice daily with milk for a duration of 4 weeks. The primary outcome measure is improvement in weight for age, while secondary outcomes include assessment of general health parameters such as appetite, activity level, sleep, bowel habits and overall well being. The study aims to assess the efficacy and safety of balaposhaka granules in the management of failure to thrive in children |