| CTRI Number |
CTRI/2025/02/080452 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study to Evaluate Effect of Paushtika Biscuit in management of Karshya in Children |
|
Scientific Title of Study
|
EFFECTIVENESS OF PAUSHTIKA BISCUIT IN THE MANAGEMENT OF KARSHYA IN CHINDERN - A SINGLE ARM PRE-POST DESIGN 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 Fenil Prajapati |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital |
| Address |
Post Graduate Department of Kaumarbhrutya, J.S Ayurved Mahavidhyalaya,College Road Nadiad -387001.
Kheda,Gujarat.
Kheda
GUJARAT
387001
India |
| Phone |
9537363076 |
| Fax |
|
| Email |
fenilprajapati778@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rutu Patel |
| Designation |
Professor and HOD Department of kaumarbhrutya . |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital |
| Address |
Post Graduate Department of Kaumarbhrutya, J.S Ayurved Mahavidhyalaya,College Road Nadiad-387001
Kheda,Gujarat.
Kheda
GUJARAT
387001
India |
| Phone |
9428600605 |
| Fax |
|
| Email |
drrutu8784@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutu Patel |
| Designation |
Professor and HOD Department of kaumarbhrutya . |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital |
| Address |
Post Graduate Department of Kaumarbhrutya, J.S Ayurved Mahavidhyalaya,College Road Nadiad-387001
Kheda,Gujarat.
GUJARAT
387001
India |
| Phone |
9428600605 |
| Fax |
|
| Email |
drrutu8784@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurved Teaching PharmacyJ.S Ayurveda Mahavidhyalaya Nadiad |
|
|
Primary Sponsor
|
| Name |
J.S Ayurveda Mahavidhyalaya & P.D Patel Ayurved Hospital,Nadiad |
| Address |
Post Graduate Department of Kaumarbhrutya, J.S Ayurved Mahavidhyalaya,College Road Nadiad -387001.
Kheda,Gujarat. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Fenil Prajapati |
P D Patel Ayurved Hospital |
Post Graduate Department of Kaumarbhrutya, J.S Ayurved Mahavidhyalaya,College Road Nadiad -387001.
Kheda,Gujarat.
Kheda
GUJARAT |
09537363076
fenilprajapati778@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee MAM university-Nadiad |
Approved |
| Institutional ethical committee for Human research |
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: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Paushtika biscuit, Reference: NA, Route: Oral, Dosage Form: Ksheerpaka, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Age Group:- 2-5 years, irrespective of religion, gender and socio-economic status.
Patients with the weight,according to IAP Classification of Malnutrition
Grade-I (70-80%)(Mild underweight children) and
Grade-II (61-70%) (Moderate underweight children)-the expected weight for age. |
|
| ExclusionCriteria |
| Details |
Children with less than 60% of ideal weight for age .
Children having systemic,neurological,endocrinal disorders, congenital anomalies and anatomical defects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes of weight and general health in Children. |
treatment for 8 week and will be assesed for 2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the effect of paushtik biscuit and its other advantages and disadvantages |
treatment for 8 week and will be assesed for 2 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2025 |
| Date of Study Completion (India) |
01/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This part gives an overall
review of this research work undertaken and includes the conclusions derived
from the study. The bibliography and the research proforma are lastly appended.
|