| CTRI Number |
CTRI/2024/12/078456 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Nutrition Powder in children with severe and moderate acute malnutrition |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Non-comparator study to assess the efficacy and safety of AshwaVita Nutrition Powder in participants (children age between 1 to 15 years) with uncomplicated severe and moderate acute malnutrition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RD-001-ASH version 03 dated 25 Jul 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Rathod |
| Designation |
Principal Investigator |
| Affiliation |
Sardar Children Hospital |
| Address |
Sardar Children Hospital
Third Floor B/7
Sardar Patel Mall
Nikol Gam Road
Khodiar Nagar
Ahmadabad
GUJARAT
382350
India |
| Phone |
9825616043 |
| Fax |
|
| Email |
drmaheshjrathod28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Rathod |
| Designation |
Principal Investigator |
| Affiliation |
Sardar Children Hospital |
| Address |
Sardar Children Hospital
Third Floor B/7
Sardar Patel Mall
Nikol Gam Road
Khodiar Nagar
GUJARAT
382350
India |
| Phone |
9825616043 |
| Fax |
|
| Email |
drmaheshjrathod28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash Patel |
| Designation |
Director |
| Affiliation |
Allied Pharmalink |
| Address |
Clinical Operation
13 Sakan Twins
Opp Satelite Centre
Mansi cross road
Vastrapur
Ahmadabad
GUJARAT
380015
India |
| Phone |
8849831339 |
| Fax |
|
| Email |
Prakash.patel@alliedpharmalink.com |
|
|
Source of Monetary or Material Support
|
| Rediskovar Innovative Products LLP
11/1, Malav Estate, Opp. Bajran Estate, Nr. Nagarwel Hanuman Temple, Amraiwadi, Ahmedabad - 380026, India |
|
|
Primary Sponsor
|
| Name |
Rediskovar Innovative Products LLP |
| Address |
11/1 Malav Estate
Opp Bajran Estate
Nr Nagarwel Hanuman Temple
Amraiwadi Ahmedabad 380026 |
| 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 Mahesh Rathod |
Sardar Children Hospital |
Clinical Research Room
Third Floor B/7
Sardar Patel Mall
Nikol Gam Road
Khodiar Nagar Ahmedabad 382350
Ahmadabad
GUJARAT |
9825616043
drmaheshjrathod28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee L. M. College of Pharmacy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E40-E46||Malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AshwaVita Powder |
About 5 gm once a day with drinking water for 12 weeks |
| Comparator Agent |
Placebo Powder |
About 5 gm once a day with drinking water for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Child with Moderate or Severe Acute Malnutrition
Child parent/legal representative willing to give a voluntary written informed consent and agree to come for regular follow up
Child assent (verbal oral or written as applicable) |
|
| ExclusionCriteria |
| Details |
Child having other acute and chronic systemic illnesses or requiring emergency management
Child has a known hypersensitivity to any of the study drugs or excipients
Child with developmental disorders like cerebral palsy or intellectual disability
Child with an inborn error of metabolism, congenital abnormalities
Child with a known history or present condition of allergic response to milk or any other ingredient of the formulation
Child with neurobehavioral disorders like ADHD autism |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of change in Mid Upper Arm Circumference from baseline value
Assessment of change in weight-for-height Z score (as applicable)
Assessment of change in weight from baseline weight |
Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of change in BMI from baseline value
Assessment of change in weight-for-age Z score (as applicable) at week 12
Adverse events |
Week 12 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
31/12/2024 |
| 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="4"
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 study is a
randomized, multiple-dose, two-arm, placebo-controlled, double blind, parallel
design evaluating efficacy
and safety of AshwaVita Nutrition Powder in 150 children with uncomplicated severe and moderate acute malnutrition for 12 weeks in
India.
The
primary outcome measures will be change in Mid Upper Arm Circumference, change
in weight-for-height Z score & change in weight from baseline weight at
week 12.
Overall, aim of the propose
research is to validate efficacy & safety of AshwaVita Nutrition Powder in acute malnutrition. |