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CTRI Number  CTRI/2024/04/066011 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 07/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain Management in Neonates using Aryurved Drugs 
Scientific Title of Study   A Comparative Study To Assess The Analgesic Effect Of Rasna Syrup With 24% Sucrose In Procedural Pain In Neonates. 
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 Shubham Kadam 
Designation  PG SCHOLAR 
Affiliation  Bharati Vidyapeeth Deemed to be University College of Ayurved 
Address  Bharati Vidyapeeth (Deemed To Be University) College Of Ayurved, Department of Kaumarbhritya, opd no 9, Dhankwadi campus katraj pune 411 0433

Pune
MAHARASHTRA
411043
India 
Phone  7304155808  
Fax    
Email  shubham.kadam-ayurved@bvp.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Gujarathi 
Designation  Professor and HOD 
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune 
Address  Bharati Vidyapeeth (Deemed To Be University) College Of Ayurved, Department of Kaumarbhritya, opd no 9, Dhankwadi campus katraj pune 411 0433

Pune
MAHARASHTRA
411043
India 
Phone  9420322740  
Fax    
Email  shrigujarathi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Gujarathi 
Designation  PROFESSOR  
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune 
Address  Bharati Vidyapeeth (Deemed To Be University) College Of Ayurved, Department of Kaumarbhritya, opd no 9, Dhankwadi campus katraj pune 411 0433

Pune
MAHARASHTRA
411043
India 
Phone  9420322740  
Fax    
Email  shrigujarathi@gmail.com  
 
Source of Monetary or Material Support  
Department of Kaumarbhritya Bharti vidyapeeth ayurved hospital pune -411 043 
 
Primary Sponsor  
Name  DR SHUBHAM KADAM 
Address  Bharti vidyapeeth (Deemed To Be University) College Of Ayurved, Department of kaumarbhritya Dhankwadi campus katraj pune 411 043 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shubham Kadam  College of Ayurved and Hospital  Bharati Vidyapeeth (Deemed To Be University) , Department of Kaumarbhritya, opd no 9, Dhankwadi campus katraj pune 411043
Pune
MAHARASHTRA 		 7304155808

shubham.kadam-ayurved@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed to be University Pune India College of Ayurved Pune Satara Road Pune 411043 ETHICS COMMITTEE [BV(DU)COA EC]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Neonates scheduled to undergo venipuncture for medical evaluation 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rasna, Reference: Raj nighantu, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 0.2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-24% Sucrose SolutionName - 24% Sucrose solution Dose - 0.2ml/kg Route- Oral Frequency- OD Duration-01 day
 
Inclusion Criteria  
Age From  2.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1.Only full-term neonates who have completed 24 hours of age uneventfully.

2.Neonates delivered and admitted only at Bharti Ayurveda Hospital will be registered.

3.Neonates who require Venepuncture for investigations of any underline cause.

4.Neonates with stable vital signs like HR, RR, SPO2.

5.Neonates who are not on or not likely to be shifted on any life support system.

6. Neonates who had been fed 30 minutes prior to procedure 
 
ExclusionCriteria 
Details  1.Neonates whose age less then twenty four hours.

2.Neonates who require life support.

3.Neonates with multiple congenital anomalies.

4.Neonates with unstable vitals.

5.Neonates who required active resuscitation.

6.Neonates with SPO2 less then ninety percentage.

7.Neonates with history of perinatal depression 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint of the study will be the Reduction in pain  all the assessments will be conducted at the following time points:
1.During venipuncture
2.post procedure (30 minutes after the venipuncture procedure ) 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary endpoint of the study will be Assessment of any allergic reaction or systemic
sequelae. 		 8th week  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   29/04/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/11/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
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   “Pain is valuable once you know you have learned from it, To cure sometimes, to relieve often, to comfort always”, is a 15th century French description of the role of the physician. Although relief of pain is felt to be a cardinal principle of compassionate medicine, yet in practice, pain management is often an ignored aspect of neonatal care. `Prevention of pain among neonates is basic expectation of every parent. However, there are common misconceptions concerning newborn pain still existing in our society which include first, the false premise that newborns do not perceive pain. Secondly, that newborns do not remember pain and even if they do, it has no side effects. Thirdly that it is too dangerous to administer analgesia to newborns. Lack of adequate training of health care personnel, inability of the neonates to express themselves and fear of side effects of analgesics are some of the other reasons. This might be the reason that no available studies are there in literature which has shown use of any Ayurvedic preparation use for the prevention/management of pain in neonates.
Rasna– is being used in Ayurveda for relief of pain in adult population.So it can be tried in neonates as Rasna shows Vedanasthapak (Analgesic) activity in adults. Rasna has chemical constitute ‘diaryl heptanoids’ which exhibits prostaglandins biosynthesis inhibiting activities. Therefore, showing anti-inflammatory effect.
24% SUCROSE SOLUTION -Oral sucrose solution has been extensively studied and recommended for procedural pain relief in neonates including venepuncture. Sucrose work as relief of pain in neonates who are having painful procedure like venepuncture.
Till date many works done on Rasna and its Vedanasthapak (analgesic) effects but mainly concerned with adults.so this study will provide a detailed analysis and interpretation of Vedanasthapak (analgesic) properties of rasna on neonates
 
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