| CTRI Number |
CTRI/2023/03/050294 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study Of Nishadi Taila In Treatment Of Nabhi paka In Newborns |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate Efficacy Of Nishadi Taila In Treatment Of Nabhi Paka In Newborns |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShital Patil |
| Designation |
M.D Scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
| Address |
OPD No 1 Kaumarbhritya Dr.D.Y.PATIL College Of Ayurved and
Research Centre,Sant Tukaram Nagar,Pimpri,Pune411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7666705147 |
| Fax |
|
| Email |
shitalpatil701@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDeepak Khawale |
| Designation |
Professor and H.O.D of Kaumarbhritya Department |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
| Address |
OPD No 1 Kaumarbhritya Dr.D.Y.PATIL College Of Ayurved and
Research Centre,Sant Tukaram Nagar,Pimpri,Pune411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDeepak Khawale |
| Designation |
Professor and H.O.D of Kaumarbhritya Department |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
| Address |
OPD No 1 Kaumarbhritya Dr.D.Y.PATIL College Of Ayurved and
Research Centre,Sant Tukaram Nagar,Pimpri,Pune411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr.Shital Patil |
| Address |
OPD No 1 Kaumarbhritya Dr.D.Y.PATIL College Of Ayurved and
Research Centre,Sant Tukaram Nagar,Pimpri,Pune411018 |
| 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 |
| DrShital Patil |
Dr.D.Y.PATIL College Of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune411018 |
OPD No 1 Kaumarbhritya Dr.D.Y.PATIL College Of Ayurved and
Research Centre,Sant Tukaram Nagar,Pimpri,Pune411018
Pune
MAHARASHTRA |
7666705147
shitalpatil701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:P389||Omphalitis without hemorrhage. Ayurveda Condition: NABIVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NISHADI TAILA, Reference: YOGRATNAKAR, Route: Topical, Dosage Form: Taila, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: NISHADI TAILA CONTENTS
1 NISHA
2 LODHRA
3 PRIYANGU
4 MADHUK |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
1 Newborn baby of age group from birth upto 1 month
2 Newborn baby having sign and symptoms of Nabhi paka like redness tenderness infammation and
pus discharge from umbilicus
3 The patients whose parents are ready to participate in clinical trial by giving informed written consent
|
|
| ExclusionCriteria |
| Details |
1 Baby born with thick meconium stained liquor
2 Baby with meconium aspiration syndrome
3 Baby having other major illnesses like cardiac neurological
diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce symptoms of Nabhi paka like redness, inflammation, swelling at umbilicus |
Daily one to five days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access healing of umbilical wound. |
Daily one to five days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is single arm clinical study in which Medicinal oil Nishadi Taila will be provided to 35 patients showing classical signs and symptoms of Nabhi paka for relieving symptoms The age group taken for study trail will be between 1 day to 1 month Nishadi Tail will be locally applied twice a day daily till 5 days Follow up will be daily one to five days. Total duration of case study will be 5 days |