| CTRI Number |
CTRI/2024/02/062194 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
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 study Efficacy of Tagar Amalaka Churna in Umbilical Cord Care. |
| 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 Gajanan Ankush Cheke |
| Designation |
PhD Scholar |
| Affiliation |
Chhatrapati Shahu Maharaj Education Institute Ayurved College |
| Address |
Department of Kaumarbhritya
Chhatrapati Shahu Maharaj Education Institute Ayurved College Paithan Road Kanchanwadi
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
8087790907 |
| Fax |
|
| Email |
drgajanancheke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karuna Ratnaparkhi |
| Designation |
Prof. and HOD |
| Affiliation |
Chhatrapati Shahu Maharaj Education Institute Ayurved College |
| Address |
Department of Kaumarbhritya
Chhatrapati Shahu Maharaj Education Institute Ayurved College Paithan Road Kanchanwadi
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karuna Ratnaparkhi |
| Designation |
Prof. and HOD |
| Affiliation |
Chhatrapati Shahu Maharaj Education Institute Ayurved College |
| Address |
Department of Kaumarbhritya
Chhatrapati Shahu Maharaj Education Institute Ayurved College Paithan Road Kanchanwadi
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shahu Maharaj Education Institude Ayurved College Paithan Road Kanchanwadi Aurangabad. |
|
|
Primary Sponsor
|
| Name |
Chhatrapati Shahu Maharaj Education Institude Ayurved College Paithan Road Kanchanwadi Aurangabad |
| Address |
Paithan Road Kanchanwadi Aurangabad Maharashtra 431002 |
| 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 Gajanan Ankush Cheke |
CSMSS Ayurved College And CSMSS Ayurved Hospital and Research Center. |
OPD and IPD of Kaumarbhritya Department Paithan Road Kanchanwadi Aurangabad 431002
Aurangabad
MAHARASHTRA |
8087790907
drgajanancheke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidhyalaya and Rugnalaya Kanchanwadi Aurangabad |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tagar-amlaka churna, Reference: bhavprakash/ mishrana prakaran 38-39, Route: Topical, Dosage Form: Churna/ Powder, Dose: 30(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Neosporin powder | topical application, 30mg, BID, 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
all full term healthy neonate born with normal vaginal delivery and LSCS.
willing of parents |
|
| ExclusionCriteria |
| Details |
neonate having pain & swelling at umbilical region
neonate admitted in NICU
with congenital defects and other disorder
baby being resusciated |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mopiostness, dry cord, shrunken cord, stump formation, fall of cord, serous discharge if any, local erythema/ inflammation if any |
1,2,3,4,5,10,15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mopiostness, dry cord, shrunken cord, stump formation, fall of cord, serous discharge if any, local erythema/ inflammation if any |
15th day |
|
|
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)
|
14/02/2024 |
| 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="3"
Months="0"
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
|
Neonatal sepsis is the most important cause of morbidity and mortality , though morden medicine is proggressive but drug used in umbilical sepsis in neonates has too much side effect to establish the important of Ayurvedic concept and remedies related to nabhinal paricharya, this study is selected. |