| CTRI Number |
CTRI/2024/11/076285 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic Management In The Treatment Of Malnutrition In Children |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicines In Improving The Weight Of Children In Malnutrition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthik Babu P |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8667748588 |
| Fax |
|
| Email |
smart.kb97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Rathinasabapathi |
| Designation |
Head Of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9842765594 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Rathinasabapathi |
| Designation |
Head Of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9842765594 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main
Road Seeragapadi
Salem
TAMIL NADU
636308
India |
|
|
Primary Sponsor
|
| Name |
Karthik Babu p |
| Address |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main
Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Karthik Babu p |
Vinayaka Missions Homoeopathic Medical College And Hospital |
Department Of Paediatrics Opd Room 5D Vinayaka Missions
Homoeopathic Medical College And Hospital Nh 47 Sankari Main Road Seeragapadi Salem
TAMIL NADU
Salem
TAMIL NADU |
8667748588
smart.kb97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee vinayaka missions kirupananda variyar medical college and hospital salem |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Diet therapy with management |
Diet therapy and management is a significant approach for malnutrition especially among children. This helps with providing adequate balanced nutrition along with proper built and nourishment of the children. Duration: Advice is given 15 days once and the follow-up is taken |
| Intervention |
Individualized homoeopathic medicines along with Diet therpy and management |
Homeopathic medicines are
selected based on
the individualization of the patient.
Based on the susceptibility of
the patient the dose is selected.
Medicine is administered via
the oral route. One dose of medicine is administered orally at the start of the treatment and follow-up is taken 15 days once. The medicine is repeated as long as symptoms last and follow-up is taken for 9 months. Along with homeopathic medicines diet therapy and management are given. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children aged from 5 to 16 years
Children of both sexes
Children fulfilling IAP BMI chart. (below 3rd centile). |
|
| ExclusionCriteria |
| Details |
Children with congenital anomalies.
Children with Immune-compromised Diseases.
Children with severe malnutrition including Marasmus and kwashiorkor or both |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IAP BMI Chart |
At the baseline and the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that proposed study
Will be useful in reducing the
Symptoms severity of malnutrition using
individualized homoeopathic medicines in paediatric age
group |
At the baseline and the end of the study. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
19/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The efficiency of Individualized homoeopathic medicines in treating malnutrition has been noted in Homoeopathy literary Books such as Materia medica, the Homoeopathic Pharmacopeia of India, and Repertory; nevertheless, there is a lack of Clinical reproving, which highlights the need for further research. An exploratory Clinical study is carried out taking into account the active principle, phytochemical property,and symptoms gathered during drug proving regarding malnutrition. |