| CTRI Number |
CTRI/2025/04/084709 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Poshana biscuit an ayurvedic supplementary nutrition for low weight participants |
|
Scientific Title of Study
|
Evaluation of effectiveness of Poshan biscuit supplementation in underweight school going children |
| 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 Shwetha D |
| Designation |
BAMS MD-BalaRoga |
| Affiliation |
Tapovana Ayurvedic Medical College and Hospital |
| Address |
Professor
Department of Bala Roga
Tapovana Ayurvedic Medical College and Hospital Doddabathi Davangere
Davanagere
KARNATAKA
577566
India |
| Phone |
9844938263 |
| Fax |
|
| Email |
shwethad7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetha D |
| Designation |
BAMS MD-BalaRoga |
| Affiliation |
Tapovana Ayurvedic Medical College and Hospital |
| Address |
Tapovana Ayurvedic Medical College and Hospital Doddabathi Davangere
Doddabathi Davangere
Davanagere
KARNATAKA
577566
India |
| Phone |
9844938263 |
| Fax |
|
| Email |
shwethad7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shwetha D |
| Designation |
BAMS MD-BalaRoga |
| Affiliation |
Tapovana Ayurvedic Medical College and Hospital |
| Address |
Professor
Department of BalaRoga
Tapovana Ayurvedic Medical College and Hospital Doddabathi Davangere
Davanagere
KARNATAKA
577566
India |
| Phone |
9844938263 |
| Fax |
|
| Email |
shwethad7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| DrShwethaD |
Sir. M. Vishveshwarayya Residential School |
Doddabathi,
Davangere.
Davanagere
KARNATAKA |
9844938263
shwethad7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tapovana Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSHNYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Poshana biscuit, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Dugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
8-12 years regardless of their gender and ethnicity, having below 3rd percentile |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessing the changes in the anthropometric measurements |
0th day, 1st month, 2nd month and after the completion of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessing the changes in the Ahara jeerna shakti. |
0th day and at the end of the intervention. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="36"
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)
|
22/04/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Undernutrition is a major global health issue, especially in low- and middle-income countries. A third of the undernutrition burden worldwide is attributed to India. India, a developing nation, is responsible for around one-third of the world’s malnutrition cases. In India, 35% of children suffer from underweight, according to the NFHS report. In its acute phases, underweight is reversible. In this regard, there are several practical but efficient solutions for this period of the children’s development in our indigenous system, Ayurveda. Our research attempts to evaluate the effectiveness of the produced medication (anubhuta yoga supported by classical references) in school-age children who suffer from underweight. |