| CTRI Number |
CTRI/2023/04/051365 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A survey study on the prevalence of malnourishment among children under five years attending Ayurved college hospital Ayurved pediatrics OPD and IPD |
|
Scientific Title of Study
|
A cross-sectional study on the prevalence of malnourishment among children under five years attending Ayurved health facility |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/2023/19-1/3/23 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidya Bhushan Pandey |
| Designation |
Reader (Associate Professor ) |
| Affiliation |
Government Ayurved College and Hospital, Bilaspur, Chhattisgarh |
| Address |
Room Number 24, OPD, Department of Bala Roga (Kaumarabhritya), Government Ayurved College and Hospital, Nootan Colony, Sarkanda, Bilaspur, Chhattisgarh
Government Ayurved College and Hospial, Nagorao Shesh, Bhavan, Juna, Bilaspur, Chhattisgrah
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9827026737 |
| Fax |
|
| Email |
vidyabhushanpandeys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidya Bhushan Pandey |
| Designation |
Reader (Associate Professor ) |
| Affiliation |
Government Ayurved College and Hospital, Bilaspur, Chhattisgarh |
| Address |
Room Number 24, OPD, Department of Bala Roga (Kaumarabhritya), Government Ayurved College and Hospital, Nootan Colony, Sarkanda, Bilaspur, Chhattisgarh
Government Ayurved College and Hospial, Nagorao Shesh, Bhavan, Juna, Bilaspur, Chhattisgrah
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9827026737 |
| Fax |
|
| Email |
vidyabhushanpandeys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidya Bhushan Pandey |
| Designation |
Reader (Associate Professor ) |
| Affiliation |
Government Ayurved College and Hospital, Bilaspur, Chhattisgarh |
| Address |
Room Number 24, OPD, Department of Bala Roga (Kaumarabhritya), Government Ayurved College and Hospital, Nootan Colony, Sarkanda, Bilaspur, Chhattisgarh
Government Ayurved College and Hospial, Nagorao Shesh, Bhavan, Juna, Bilaspur, Chhattisgrah
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9827026737 |
| Fax |
|
| Email |
vidyabhushanpandeys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal and Superintendent, Government Ayurved College and Hospital, Bilaspur |
|
|
Primary Sponsor
|
| Name |
Principal and Superintendent, Government Ayurved College and Hospital, Bilaspur |
| Address |
Nagorao Shesh Bhavan, Juna Bilaspur, Chhattisgarh |
| 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 Vidya Bhushan Pandey |
Government Ayurved College and Hospital, Bilaspur, Chhattisgarh |
Room Number 24, Dept. of Bala Roga (Kaumarbhritya),Nootan Colony, Sarkanda, Bilaspur, Chhattisgarh
Bilaspur
CHHATTISGARH |
8319258115
vidyabhushanpandeys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, office of the Principal Govt. Ayurved college & hospital, Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who are willing to participate in survey study and those who will be sign the informed consent.
2. Patient of either sex with age of 5 years and below.
|
|
| ExclusionCriteria |
| Details |
1. Patient suffering of chromosomal diseases and congenital heart diseases.
2. Patient with confirmed diagnosis of any syndrome illness.
3. Patient above the age of inclusion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
–Prevalence of malnutrition among the patient attending KB OPD/IPD
–Presenting complaints of malnourished children
–Ayurveda diagnosis of those who malnourished.
|
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Presenting complaints of malnourished children
2. Ayurveda diagnosis of those who are malnourished.
|
120 days |
|
|
Target Sample Size
|
Total Sample Size="348"
Sample Size from India="348"
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)
|
26/04/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Malnutrition is a very serious problem for a
developing nation. India must have got rid of serious physically debilitating
diseases like polio today, but due success has not yet been achieved in tackling the malnutrition rate. Apart from this, Chhattisgarh state, which currently has a
malnutrition rate of 40% (Survey NFHS Nutrition in India 0D56,2005- 06), has
taken very effective steps against this problem, including successful Food
Security Act, Chief Minister’s Nutrition Program, Women and Child Development Department.1
The Nava Jatan program organized by, Malnutrition Mukti Abhiyan is the main
one. Due to the meaningful efforts of the Central and State Governments, the
rate of severe malnutrition has decreased from 51% (N.F.H.S. 02) in the
previous survey to 45% (N.F.H.S. 03).2 Malnutrition not only makes
the child physically disabled but also leads to various serious diseases. This
survey study is proposed to identify the rate of malnutrition in the patients
attending OPD/IPD of Kaumarbhritya department in the hospital and health checkup
camps organized by dept. of Kaumarbhritya outside and inside the campus of GACH Bilaspur. |