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CTRI Number  CTRI/2024/08/072533 [Registered on: 14/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management of Neonatal Jaundice using triphala guduchi arka 
Scientific Title of Study   Physiochemical Analysis and Evalution of Efficiacy of Triphala Guduchi Arka in Neonatal Jaundice 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishant Mahaveer Shastri 
Designation  2 nd year BAMS Student 
Affiliation  Shri Dharmashthala college of ayurveda  
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital Thanniruhalla BM Road Hassan 573201
Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital BM Road Thanniruhalla IPD Deparment of Kaumarabhritya
Hassan
KARNATAKA
573201
India 
Phone  9607857582  
Fax    
Email  shastrinishant1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Kumar S 
Designation  Associate Professor 
Affiliation  Shri Dharmashthala college of ayurveda  
Address  Sri Dharmasthala Manj unatheshwara College of Ayurveda Hospital Thanniruhalla BM Road Hassan 573201
Department of Kaumarabhritya Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital BM Road Thanniruhalla
Hassan
KARNATAKA
573201
India 
Phone  8197589426   
Fax    
Email  drnayanpanaje@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nishant Mahaveer Shastri 
Designation  Student 
Affiliation  Shri Dharmashthala college of ayurveda  
Address  Sri Dharmasthala Manj unatheshwara College of Ayurveda Hospital Thanniruhalla BM Road Hassan 573201
Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital BM Road Thanniruhalla IPD Deparment of Kaumarabhritya
Hassan
KARNATAKA
573201
India 
Phone  9607857582  
Fax    
Email  shastrinishant1@gmail.com  
 
Source of Monetary or Material Support  
Teaching Pharmacy Department of Rasashastra and Bhaishajya kalpana Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital BM Road Thanniruhalla Hassan  
 
Primary Sponsor  
Name  RGUHS 
Address  12, 30th Cross Rd, opp. Sagar Hospital, 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka 560041 
Type of Sponsor  Government funding agency 
 
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 
Nishant Shastri  SDM College of Ayurveda  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital BM Road Thanniruhalla Room No D101 IPD Deparment of Kaumarabhritya Hassan KARNATAKA
Hassan
KARNATAKA 		 9607857582

shastrinishant1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
COMMUNICATION OF DECISION OF INSTITUTIONAL ETHICS COMMETEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: KAMALA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphalaguduchi Arka, Reference: Arka Prakasha, Route: Oral, Dosage Form: Arka, Dose: 0.5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Normal ControlNo intervation is done. Duration: 7 Days
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  1. All new born babies extracted through LSCS
2. Neonates whose parents are willing to give written consent for the trial 
 
ExclusionCriteria 
Details  1. New born baby with birth asphyxia
2. New born baby congenital anomalies, sepsis and other systemic illnesses 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the total serum Bilirubin level   Day 0
Day 3
Day 5
Day 7  
 
Secondary Outcome  
Outcome  TimePoints 
changes in the extent of clinical icterus based on crammers criteria   Day 0
Day 3
Day 5
Day 7 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3 
Date of First Enrollment (India)   25/08/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shastrinishant1@gmail.com].

  6. For how long will this data be available start date provided 26-12-2024 and end date provided 26-07-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The objectives of the study to evaluate the thr randomised clinical trail to asses the role of Triphalaguduchi arka on preventing neonatal jaundice 
20 subjects will be accessed to give orally  Triphalaguduchi arka and assesment will be done in suaitable parameter and score will be accessed with suaitable parameter
  
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