| CTRI Number |
CTRI/2025/08/093474 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Scope of Homoeopathy in Management of Preterm neonates in Neonatal Intensive care unit(NICU) |
|
Scientific Title of Study
|
Scope of Homoeopathy as an add-on therapy in improvement of functional parameters in Pre-term neonates under standard management in Neonatal Intensive Care Unit(NICU): A single-blind randomized control trial |
| 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 Nikita Sureshchandra Mehta |
| Designation |
Ph D Scholar |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
Room no. 305, 2nd floor, Department of Pediatrics, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar- Boisar Road, Opp. S. T. Workshop, Palghar
Palghar
MAHARASHTRA
401404
India |
| Phone |
9377899597 |
| Fax |
|
| Email |
dr_nikita_mehta@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrasekhar R Goda |
| Designation |
HOD and Professor Department of Paediatrics |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
Room No. 305, 2nd floor, Department of pediatrics, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar-Boisar Road, Opp. S. T. Workshop, Palghar
Palghar
MAHARASHTRA
401404
India |
| Phone |
9322882918 |
| Fax |
|
| Email |
sujchan18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bipin S Jain |
| Designation |
Prinicpal and Professor Department of HMM |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
Room no. 134, ground floor, Prinicpal cabin, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar-Boisar Road, Opp. S. T. Workshop, Palghar
Palghar
MAHARASHTRA
401404
India |
| Phone |
9323690095 |
| Fax |
|
| Email |
drjainbipin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M L Dhawale Memorial Homoeopathic Institute, Palghar- Boisar road, Opp. S. T. Workshop, Palghar, Maharashtra . 401404 |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Sureshchandra Mehta |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar-Boisar Road, Opp. S. T. Workshop, Palghar, Maharashtra. 401404 |
| 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 Nikita Sureshchandra Mehta |
Dr M L Dhawale Memorial Homoeopathic Institute and Trust hospital |
Department of Paediatrics, Room no. 305,OPD room no. 111, Department of pediatrics, Palghar-Boisar Road, Opp. S. T. Workshop, Palghar
Palghar
MAHARASHTRA |
9377899597
dr_nikita_mehta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Dr M L Dhawale Memorial Homoeopathic Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated Homoeopathic Remedy |
Intervention - indicated homoeopathic remedy
Dose - 0/1 or 30 or 200 potency as per susceptibility of the patient
Frequency - 2 hourly/ 4 hourly/ 8 hourly as per susceptibility of the patient
route of administration - Dissolved in expressed breast milk through RT/ orally/ rubbed on the skin as per the individual patients clinical state
Total duration - 7-10 days or more or less as per the need of patient/ day of admission till discharge/ first follow up
Comparator - None |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Pre-term neonates (born before 37 weeks of gestation) of more than 28 weeks of gestational age.
2. Admitted to the NICU and receiving standard NICU management care under the neonatologist.
3. Assent and Informed Consent obtained from the parents for their neonate admitted to NICU |
|
| ExclusionCriteria |
| Details |
1. Neonates with severe congenital anomalies or genetic disorders who require immediate surgical/ cardiac interventions at higher centers.
2. Neonates with life-threatening conditions where immediate intensive care and referral to higher centers are required.
3. Neonates of gestational age less than 28 weeks (extremely preterm neonates) |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in specific functional parameters—namely respiratory rate, weight gain, and feeding efficiency—in preterm neonates receiving Homoeopathy as an add-on therapy alongside standard NICU care, compared to those receiving standard NICU care alone. |
Baseline, day 2, Day 3, day 4, week 2, week 3, discharge and 1st follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluation of the broader scope of Homoeopathy in enhancing functional health indicators in preterm neonates when used as an adjunct to conventional NICU management.
2. Comparison of morbidity & mortality rates between neonates receiving standard NICU care & those receiving additional Homoeopathic treatment.
3. Assessment of neurodevelopmental outcomes in both groups using standardized developmental screening tools at discharge or follow-up.
4. Measurement of the length of NICU stay to determine whether Homoeopathy contributes to earlier discharge.
5. Documentation & analysis of specific Homoeopathic remedies administered, including their frequency, potency, & observed clinical effectiveness in preterm neonates.
|
Baseline, day 2, day 3, day 4, week 2, week 3, discharge, 1st follow up |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
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
|
In this single-blind, randomized, placebo-controlled experimental study, the aim is to evaluate the Scope or effectiveness of Homoeopathy as an add-on therapy in improving functional parameters in preterm neonates receiving standard NICU care. Eligible neonates will be randomly assigned to either the experimental group (receiving Homoeopathic intervention) or the control group (receiving placebo), alongside standard NICU treatment. Functional outcomes such as respiratory rate, weight gain, and feeding efficiency will be assessed and compared between groups. Statistical analysis will be conducted to determine the significance of observed differences, and the null or alternate hypothesis will be accepted or rejected accordingly. |