| CTRI Number |
CTRI/2024/06/068463 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Nutritional Status of Children with Cerebral Palsy in Varanasi and Clinical Observational Study on the Effect of Suvarnaprashana in Children with C P. |
|
Scientific Title of Study
|
A Cross – Sectional Study on Nutritional Status of Children with Cerebral Palsy in Varanasi and a Prospective Clinical Observational Study on the Effect of Suvarnaprashana in Children with C P. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Pandey |
| Designation |
PhD Schollar |
| Affiliation |
Istitute of Medical Science BHU |
| Address |
Department of Kaumarbhritya Faculty of Ayurveda IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839915100 |
| Fax |
|
| Email |
nishapandey1990@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Patni |
| Designation |
Asst Professor |
| Affiliation |
Institute of Medical Science BHU |
| Address |
Department of Kaumarbhritya Faculty of Ayurveda IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Patni |
| Designation |
Asst Professor |
| Affiliation |
Institute of Medical Science BHU |
| Address |
Department of Kaumarbhritya Faculty of Ayurveda IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Sir Sundar Lal Hospital, Institute of Medical Science, Banaras Hindu University Varanasi 221005, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science BHU Varanasi |
| Address |
Dept of Kaumarbhritya/Balroga
Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi 221005,Uttar Pradesh, 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 Kalpana Patni |
Sir Sundar Lal Ayurvedic Hospital IMS BHU Varanasi |
OPD NO 25,Dept of Kaumarbhritya/Balroga Faculty of Ayurveda IMS BHU Varanasi 221005
Varanasi
UTTAR PRADESH |
9456140578
kalpana.patni@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BanarasHinduUniversityInstituteofMedicalSciencesVaranasiIndia221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, (2) ICD-10 Condition:P919||Disturbance of cerebral status ofnewborn, unspecified. Ayurveda Condition: Children with Mastishk Pakshaaghaat(cerebral palsy) with devlopmental disabilities of both physical and mental, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Day(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with CP
2. Age-1 year to 5 years of either sex.
3. Children with developmental disabilities of both physical and mental (Delayed
milestones). |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of nutritional status parameters including weight, height, BMI, and micronutrient levels.
2.Identification of prevalent nutritional deficiencies among children with cerebral palsy in Varanasi.
3.Evaluation of the impact of Suvarnaprashana on the developmental milestones of children with cerebral palsy.
4.Measurement of changes in motor function and cognitive abilities following Suvarnaprashana administration. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Exploration of dietary patterns and feeding difficulties among children with cerebral palsy.
2.Analysis of the correlation between nutritional status and severity of cerebral palsy symptoms.
3.Investigation of the safety profile of Suvarnaprashana in children with cerebral palsy.
4.Examination of potential improvements in quality of life indicators such as sleep patterns and mood. |
1 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/06/2024 |
| 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="2"
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
|
cross sectional study (n= 150) pre-diagnosed children of Cerebral Palsy will be selected from OPD & IPD of department of Kaumarabhritya, Sir Sunderlal Hospital, BHU, Varanasi District. Study includes children between 1 year to 5 years
For Observational Clinical study (n=60) also pre-diagnosed children of Cerebral Palsy will be selected from OPD & IPD of department of Kaumarabhritya, Sir Sunderlal Hospital, BHU, Varanasi District. Only those children with CP who will be prescribed Suvarnaprashana for 6 weeks along with Snehana (Ashwagandha bala tail)15 mint and Swedana (Shali Shashtika Pinda Sweda) 15 mint will be assigned to intervention group 20 days and those who will be prescribed only Snehana (Aswagandha bala tail) 15 mint and Swedana (Shali Shashtika Pinda Sweda) 15 mint will be assigned to comparator group20 days. All registered patients will have received recommendation for Suvarnaprashana and other procedures by their respective Consultant from department of Kaumarbhritya/ Balroga, Faculty of Ayurveda IMS BHU after through clinical examination. Parent/guardian of every selected patient will be explained about the procedure of observation upon the child and thereby obtained his consent.Total duration of trial will be 2 months(8 weeks).
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