| CTRI Number |
CTRI/2022/03/041215 [Registered on: 21/03/2022] Trial Registered Prospectively |
| Last Modified On: |
17/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY ON PHYSIOLOGICAL CHANGES OF NEWBORNS CARED AS PER AYURVEDIC PRINCIPLES |
|
Scientific Title of Study
|
STUDY ON PHYSIOLOGICAL TRANSITION OF NEWBORNS CARED ACCORDING TO NAVAJATA SHISHU PARICHARYA – A RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TAHA MUBEEN |
| Designation |
PG SCHOLAR |
| Affiliation |
KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA BELAGAVI |
| Address |
KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA BELAGAVI
KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA BELAGAVI
Belgaum
KARNATAKA
590003
India |
| Phone |
9739240937 |
| Fax |
|
| Email |
tahamubeencool@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aziz Ahmed I Arbar |
| Designation |
Professor and HOD, Department of kaumarabhritya |
| Affiliation |
Kahers shri BMK ayurveda mahavidyalaya |
| Address |
Kahers Shri BMK Ayurveda Mahavidyalaya Belagavi
Shri BMK ayurveda mahavidyalaya belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Taha Mubeen |
| Designation |
PG Scholar |
| Affiliation |
Kahers Shri BMK Ayurveda Mahavidyalaya |
| Address |
Kahers Shri BMK Ayurveda Mahavidyalaya Belagavi
Shri BMK Ayurveda Mahavidyalaya Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9739240937 |
| Fax |
|
| Email |
tahamubeencool@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Ayurveda hospital belagavi |
|
|
Primary Sponsor
|
| Name |
KLE ayurveda hospital |
| Address |
shri BMK ayurveda hospital |
| Type of Sponsor |
Private 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 taha mubeen |
KLE Ayurveda Hos[ital Belgavi |
shri BMK AYurveda hospital belagavi
Belgaum
KARNATAKA |
9739240937
tahamubeencool@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITEE OF ETHICS ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: NAVAJATA SHISHU PARICHARYA, (2) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: NAVAJATA SHISHU PARICHARYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | NRP guidelines as per IAP | Neonatal resuscitation program as per IAP guidelines..
1) Recieve baby in prewarmed cloth
2) wipe out secretions if any
3) Dry the baby in cephalocaudal manner and remove wer linen
4) cord clamp and cut
3) | | 2 | Intervention Arm | Procedure | - | Navajatha shishu paricharya | (Procedure Reference: Ashtanga hrudaya, uttara tantra, chapter 1, Procedure details: Ulba parimarjana
Ashmano sanghatana
Mukha parisheka
Mukha vishodhana
Nabhinala chedana)
(1) Medicine Name: Kushta taila, Reference: Ashtanga hrudaya, uttaratantra, , Route: Topical, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1) Baby cried immediately after birth
2) APGAR score >7
3) Birth weight (>2.5kg)
3) Clinically stable newborns |
|
| ExclusionCriteria |
| Details |
1) Meconium stained
2) Baby not cried immediately after birth
3) Asphyxia
4) Respiratory distress
5) LBW
6) Preterm
• Babies with birth injuries
• Congenital anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Normal physiological transition of newborns cared according to navajata shishu
paricharya |
1 min, 5 min, 10 min, 15 min, 30 min, 45 min, 1 hour, 2 hour, 4 hour, 6 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Parameters assessed as primary outcome measures are : APGAR score, BP, SpO2, Respiratory rate, Capillary refilling time, Temperature, color, Respiratory distress score, Activity and Random Blood sugar,
Secondary outcome : Newborn cared according to Navajata shishu paricharya and Newborns cared according to IAPS Neonatal resuscitation program, shows similar physiological changes. |
1St min, 5th min, 10th min, 15th min, 30th min, 45th min, 1st hour, 2nd hour, 4th hour, 6th hour |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/04/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stabilization and resuscitation of babies at birth is one of the most frequently performed procedure and requires considerable skills. About 3.3millions death occur during the Neonatal period, the majority i.e., almost 2millions die on the first day of life. With the birth of 25 million children each year India accounts for nearly one fifth of the world’s annual child births. Every minute one of those babies dies and 40 per cent of neonatal deaths happen during the first 24 hours after birth. Virtually 99% Newborn deaths occur in low-middle income country due to lack of proper intervention at the time of birh. Most of the deaths can be avoided by ensuring proper resuscitation, care of umbilical cord and immediate exclusive breast feeding. Ayurveda the authentic Indian medicine had already described in detail the principles of newborn care 5,500 years (3500 BC) ago in Kaumarabhritya (the science of pediatrics). Navajata shishu paricharya3,4,5,6 steps described by ayurvedic classical texts are very close to modern day principles of newborn care. The Ayurvedic practices of ancient era were primarily based on observation and experience. Navajata shishu paricharya includes few prodigious steps which are not mentioned in newborn care as per Neonatal resuscitation program(NRP) guidelines. However, the navajata shishu paricharya is relevant to today’s practice but the evidence-based studies have not been conducted till date. |