| CTRI Number |
CTRI/2026/01/102492 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to See Whether Pedesheild Syrup Helps Improve Growth in Underweight Children |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECT OF PEDESHEILD SYRUP IN PROMOTING GROWTH PARAMETERS IN MODERATELY UNDERWEIGHT 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 |
Rehan mujeeb khan |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul institude of ayurved , Parul university |
| Address |
room no 204 , parul university , waghodia , Dept of kaumarbhritya
vadodara Gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
09604796363 |
| Fax |
|
| Email |
drrehankhan1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavya mohan |
| Designation |
Associate Professor |
| Affiliation |
Parul institude of ayurved , Parul university |
| Address |
room no 204 , parul university , waghodia , Dept of kaumarbhritya
vadodara Gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
9745727376 |
| Fax |
|
| Email |
kavya.thannickel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavya mohan |
| Designation |
Associate Professor |
| Affiliation |
Parul institude of ayurved , Parul university |
| Address |
room no 204 , parul university , waghodia , Dept of kaumarbhritya
vadodara Gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
9745727376 |
| Fax |
|
| Email |
kavya.thannickel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul university Limda Vadodara Gujrat 391760 |
|
|
Primary Sponsor
|
| Name |
PARUL UNIVERSITY |
| Address |
Parul university Limda Vadodara Gujrat 391760 |
| 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 Rehan khan |
Parul Institute Of Ayurved |
Room NO 204
Parul Institute Of Ayurved
Parul University
Vadodara
Gujarat
Vadodara
GUJARAT |
9604796363
drrehankhan1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | ICDS diet | ICDS Diet According To Government Protocol | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pedesheild Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: NA | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:ICDS Diet According To Government Protocol, Pathya/Apathya:no, Pathya:ICDS Diet According To Government Protocol, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Subjects within age group 3 to 5 years will be included in the study irrespective of sex, caste and religion
Subjects with the weight from less than minus 2 SD for the expected weight for age
Parents or Guardian willing to give informed written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patient associated with Severe malnutrition.
K or co or o Congenital Diseases, Inborn Errors of Metabolism and any other systemic disorders.
Severely underweight children. (less than 3 SD as per WHO Child Growth Standard 2006)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Pedesheild Syrup along with ICDS standard diet on physical growth parameters such as weight and height and BMI in moderately underweight children
|
30 days 60 days 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety, palatability, and compliance of the Pedesheild Syrup along with ICDS standard diet in moderately underweight pediatric population |
30 days 60 days 90 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2026 |
| 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
|
This open label randomized clinical trial evaluates the efficacy and safety of Pedesheild Syrup a polyherbal Ayurvedic formulation in improving growth parameters of moderately underweight children aged 3 to 5 years along with the ICDS standard diet Based on Ayurvedic principles of Rasayana Deepana Pachana Agni enhancement Dhatu nourishment and Ojas support 120 children will be treated for 90 days with assessment of weight height BMI and other anthropometric measures aiming to establish Pedesheild Syrup as a safe palatable and effective integrative therapy for healthy growth |