| CTRI Number |
CTRI/2022/12/048635 [Registered on: 30/12/2022] Trial Registered Prospectively |
| Last Modified On: |
28/12/2022 |
| 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
|
A clinical study to evaluate the effect of local ayurvedic application in umbilical cord care. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to compare erandmool-amlak churna with neosporin powder in umbilical cord care. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikita Sanjay Gadakh |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarbhritya,Tilak Ayurved Mahavidyalaya,Pune 11
Pune
MAHARASHTRA
411011
India |
| Phone |
9960615313 |
| Fax |
|
| Email |
nikita3101995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Jaybhay |
| Designation |
HOD |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarbhritya, Tilak Ayurved Mahavidyalaya, Pune 11
Pune
MAHARASHTRA
411011
India |
| Phone |
8888587158 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Jaybhay |
| Designation |
HOD |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarbhritya, Tilak Ayurved Mahavidyalaya, Pune 11
Pune
MAHARASHTRA
411011
India |
| Phone |
8888587158 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya,Rasta peth,Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya ,Pune |
| Address |
Rasta peth ,Pune-11 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sanjay Gadakh |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital |
OPD no.20 and IPD of Department of Kaumarbhritya
Pune
MAHARASHTRA |
9960615313
nikita3101995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Umbilical cord care in newborn to prevent umbilical sepsis |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandmool-Amalak Churna, Reference: Arogya Raksha Kalpadrum adhyay 28 and Yogratnakar Abhav warg, Route: Topical, Dosage Form: Churna/ Powder, Dose: 30(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Avoid water or oil application at umbilical region. | | 2 | Comparator Arm (Non Ayurveda) | | - | Neosporin powder | Dose-30 mg
Duration-15 days
Frequency-TDS
Route-topical application |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All Full term neonates
Willing of parents |
|
| ExclusionCriteria |
| Details |
Neonates having pain or swelling or any inflammation sign at umbilical region.
Neonates admitted in NICU.
Non willing parents.
Neonates having congenital defects or who have been resuscitated. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fall of umbilical cord without any inflammation and discharge. |
baseline,3days,5days,7days,15days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serous or any other discharge , inflammation after falling of umbilical cord. |
15 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neonatal sepsis is the most important cause of morbidity and mortality.Though modern medicine is progressive but drugs used in umbilical sepsis in neonates has too much side effects so to establish the importance of Ayurvedic concepts and remedies related to Nabhinal paricharya,this study is selected. |