| CTRI Number |
CTRI/2024/11/077091 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Interventional Meal Plan] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
An Extensive Investigation Into the Growth and Development of Kids from Various Prakriti With A Focus On Malnourishment In the Varanasi District. |
|
Scientific Title of Study
|
A Comprehensive Study of Growth and Development in Children of Different Prakriti Psycho Somatic Constitution With Special Reference to Malnutrition in Varanasi District. |
| 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. Prem Shanker Upadhyay |
| Designation |
Head and Associate Professor |
| Affiliation |
Institute Of Medical Sciences |
| Address |
Department Of Kaumarbhritya/Balroga, Faculty of Ayurveda, Institute Of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7355422083 |
| Fax |
|
| Email |
upadhyayps1974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aanmoul Neidhhii |
| Designation |
Research Scholar |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department Of Kaumarbhritya/Balroga, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7209812578 |
| Fax |
|
| Email |
aanmoul1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Prem Shanker Upadhyay |
| Designation |
Head and Associate Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Kaumarbhritya/Balroga, Faculty of Ayurveda, Institute Of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7355422083 |
| Fax |
|
| Email |
upadhyayps1974@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya Ayurvedic wing Institute of Medical Sciences Banaras Hindu University Varanasi 221005 India |
|
|
Primary Sponsor
|
| Name |
Institute Of Medical Sciences Banaras Hindu University |
| Address |
Department of Kaumarbhritya Ayurveda Wing Institute Of Medical Sciences Banaras Hindu University Varanasi 221005 India |
| Type of Sponsor |
Government medical college |
|
|
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 PS Upadhyay |
Sir Sunderlal Hospital |
Room no. 25,Kaumarbhritya/Balroga, Ayurveda Wing
Varanasi
UTTAR PRADESH |
7355422083
upadhyayps1974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institutional Ethics Committee Institute Of Medical Sciences Varanasi India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: DAURBALYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | General Follow Up | It will be a general enquiry with the participants about the precautions that are been taken to prevent them from becoming malnourished. the main focus will be on the food that is been taken for a total duration of eight months at an interval of 2 months. | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Mix fruits bowl, Buttermilk /Atta ka Halwa(with dry fruits) milk (with jaggery/ raisins) Sliced cucumber/ carrot. Yoghurt added with fruits Vegetable dalia khicadi/ Egg pulav for a total duartion of eight months.follow up will be conducted after every 2 months, Apathya:junk foods, processed foods, ready to eat foods are to be avoided for a total duration of eight months. |
|
| Intervention |
7 DAY INTERVENTIONAL MEAL PLAN |
A MEAL PLAN FOR A WEEK IS GIVEN TO THE PATIENT DEPENDING ON THE FOOD CHOICES. THE PATIENT WILL HAVE TO FOLLOW IT FOR 2 MONTHS AFTER REGISTRATION AND THEN FOLLOW UP WILL BE TAKEN EVERY 2 MONTHS FOR A PERIOD OF 8 MONTHS. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Children should either be underweight or normal. Only mild (grade 1) and moderate level (grade 2) of malnourishment will be included in the study.
Age group 1 year - 3 years.
Children irrespective of their sex and religion will be included in the study.
Written consent of the parent’s for registration of children will be considered.
|
|
| ExclusionCriteria |
| Details |
Children less than 1 year or more than 3 years.
Children who have any life threatening disease or ailment or any congenital anomalies.
Feeding other than the oral route.
Children with severe (Grade 3) and very severe malnourishment (Grade 4) will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The relation of prakriti with the physical growth and development of the child will be assessed
|
baseline, at 2 months, at 4 months, at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of cognitive development.
Assessment of prakriti.
Assessment of food habit.
Assessment of relation of growth & development with food habits of children
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 4 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is randomised three groups comparative interventional study to assess the efficacy of the mentioned study in the management of malnutrition. The study aims to conduct the trial on 240 children from the OPD of Ayurvedic Wing of Banaras Hindu University. The Study includes children between 1 to 3 years of age. The interventional plan is oral in nature. The complete study is divided into 3 groups which are further divided into 3 sub groups comprising: normal, Grade 1 and Grade 2 of malnourishment on the basis of classification given by IAP(Indian Academy of Pediatrics). The interventional Plan will be given after registration and follow up sessions we be conducted every 2 months for a period of 8 months (a total of registration+3 follow ups). |