| CTRI Number |
CTRI/2022/08/044567 [Registered on: 02/08/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Pedia Power - A Nutritonal Supplement for Children |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Pedia Power†of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/NUT/062/20 Version 01 03May22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Department of General/Family Medicine Room no 7. #180/109, G1&G2, RR Villa, Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Department of General/Family Medicine Room no 7. #180/109, G1&G2, RR Villa, Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Department of General/Family Medicine
Room no 7.
#180/109, G1&G2, RR Villa, Rangarajapuram Main Road,
Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Essen Fooddies India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Essen Fooddies India Pvt Ltd |
| Address |
KINFRA Park, Kakkancherry
Malappuram 673635,
Kerala, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai 600024
Tamil Nadu |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Department of General/Family Medicine
Room no 7. #180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinically Healthy Children aged between 5 and 14 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None. |
None |
| Intervention |
Pedia Power |
Route of Administration : Oral
Formulation : Powdered Nutritional Formulation
Dose : 50g (5 scoops) in 150ml luke warm water
Dosage : OD for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically healthy children between aged 5 and 14 years (both ages and all genders inclusive).
2. Children must be able to comprehend the language spoken and must have mastered verbal communication enough to understand and answer questions.
3. Children whose parents/guardian are willing to sign the informed consent for participation in the clinical study and are able to understand and ensure that their child/ward follows the responsibilities of the study.
4. Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health.
5. Subjects who have scored ≤1 in STRONGKids Questionnaire at the time of screening.
6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to the ingredients of the investigational product.
2. Children who are identified with Galactosemia, Type I Diabetes Mellitus, Epilepsy and any other disorder that limits normal nutritional intake
3. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
4. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
5. Subjects on remission from cancer of any type less than 5 years at the time of screening
6. Subjects who have participated in a clinical study less than 1 month before screening
7. Any significant medical condition (e.g., significant psychiatric or neurological disorders), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
8. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
9. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anthropometric Measurements: Improvement of 10% from baseline.
2. Fluency Test: Improvement of 10% from baseline.
3. General Appetite: Improvement of 10% from baseline.
4. IPFBQ: Total Score of 20.
|
1. Anthropometric Measurements : Day 1, Day 45, Day 90
2. Fluency Test : Day 1, Day 45 Day 90
3. General Appetite : Day 1, Day 45, Day 90
4. IP Feedback Questionnaire : Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/06/2023 |
| Date of Study Completion (India) |
09/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None. Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design : Open Label, Prospective, Non-Randomised,
Non-Comparative, Single Arm Clinical Study
Indication : Nutritional Supplement for Clinically healthy Children
Investigational Product Details
Name : PEDIA POWER
Route of Administration : Oral
Formulation : Powdered Nutritional Formulation
Dose : 50g (5 scoops) in 150ml luke warm water
Dosage : OD for 3 months
Subject Population : linically healthy children between the ages of 5 and
14 years (both ages and all genders inclusive).
Treatment Arms : One. Non Comparative Single Arm
Study
Number of Subjects : 50 Subjects
Efficacy Assessments:
1. Anthropometric Measurements : Day 1, Day 45, Day 90
2. Fluency Test : Day 1, Day 45 Day 90
3. General Appetite
: Day 1, Day 45, Day 90
4. IP Feedback Questionnaire : Day 90
Safety Assessments:
1. Clinical Safety : CBC, Serum Biochemistry
2. Monitoring of Adverse Events
Background of the study: A
dietary supplement provides nutrients either extracted from food sources or
that are synthetic in order to increase the quantity of their consumption. The
class of nutrient compounds includes vitamins, minerals, fiber, fatty acids and
amino acids. Childhood and adolescence
are periods of continuous growth and development. To tackle this and to retain
the balanced nutritional status for the normal growth and development of
children, nutritional supplements are widely used. As children grow, it’s
important for them to get enough vitamins and minerals to ensure optimal health
and also it’s vital to get adequate amounts of nutrients that help them build
strong bones, such as calcium and vitamin D. Moreover, iron, zinc, iodine,
choline, and vitamins A, B6 (folate), B12, and D are crucial for brain
development in early life.
Purpose of the Study : Pedia Power is a powdered nutritional
formulation by Essen Fooddies India Pvt.
Ltd. with nutrients that are essential to supplement children in improving
the height, weight and brain development. It contains essential nutrients which
includes- Carbohydrates, protein, fats, vitamins, minerals and essential amino
acids that helps the child in height, weight and brain development; It also
aids in improving overall physical growth and supports Immunity. |