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CTRI Number  CTRI/2025/02/081454 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Study To find The Effect Of Triphaladi Arka In Neonatal Hyperbilirubinemia 
Scientific Title of Study   Randomized Controlled Clinical Study To Evaluate The Effect Of Triphaladi Arka In Neonatal Hyperbilirubinemia 
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 Sanjay K Solanki 
Designation  Post Graduate Scholar  
Affiliation  Rajiv Gandhi University Of Health Sciences,Banglore 
Address  Room Number 16 Ground floor Department of Kaumarabrithya Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  8792377035  
Fax    
Email  pg23162@sdmcahhassan.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nayan Kumar S 
Designation  Associate Professor 
Affiliation  Rajiv Gandhi University of Health Sciences, Banglore 
Address  Room Number 16 Ground floor Department of Kaumarabrithya Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  8197589426  
Fax    
Email  drnayankumar@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  Dr Nayan Kumar S 
Designation  Associate Professor  
Affiliation  Rajiv Gandhi University of Health Sciences , Banglore  
Address  Room Number 16 Ground floor Department of Kaumarabrithya Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  8197589426  
Fax    
Email  drnayankumar@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Department Of Kaumarabrithya Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 Karnataka India 
Self -Dr Sanjay K Solanki 
 
Primary Sponsor  
Name  Dr SANJAY K SOLANKI  
Address  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN 573201 KARNATAKA INDIA  
Type of Sponsor  Other [SELF FUNDED] 
 
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 Sanjay K Solanki  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan   IPD Department of Kaumarabrithya SDM College of ayurveda and hospital, BM Road, taniruhalla , Hassan 573201
Hassan
KARNATAKA 
8792377035

Pg23162@sdmcahhassan.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 573201 Karnataka India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:P599||Neonatal jaundice, unspecified. Ayurveda Condition: KAMALA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Control GroupRoutine New Born Care
2Intervention ArmDrugClassical(1) Medicine Name: Triphaladi Arka, Reference: Astanga Hrudaya Uttara Sthana, Route: Oral, Dosage Form: Arka, Dose: 0.5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: Routine New Born Care
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  6.00 Day(s)
Gender  Both 
Details  Healthy neonates of either gender, irrespective of caste and creed extracted through LSCS.
Term neonates with body weight between 2500 to 3500 grams.
Neonates, whose parents are willing to give consent for the trial. 
 
ExclusionCriteria 
Details  Newborn with birth asphyxia or with APGAR score less than 7
Newborn with congenital anomalies
Newborns with any medical or surgical illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Samples Of Blood Will Be Collected In Two Groups Of New Borns
First Group Will Be Intervened With Triphaladi Arka Along With Routine New Born Care And Second Group Will Be Control Group Who Will Be Given Only New Born Care 
Samples Of Blood Will Be Collected In Two Groups Of New Borns
New Borns Will be Assessed For Serum Bilirubin And Kramers Rule At Interval Of Birth Day , Second Day, Fourth Day And Sixth Day 
 
Secondary Outcome  
Outcome  TimePoints 
To Evaluate The Effect Of Triphaladi Arka In Neonatal hyperbilirubinemia  Assessment Of Serum Bilirubin And Kramers Rule At Intervals Of Birth Day, Second Day , Fourth Day And Sixth Day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   17/03/2025 
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 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 - NO
Brief Summary  

Neonatal hyperbilirubinemia is the most common clinical condition seen in contemporary science, this accounts for 60 percentage cases in term babies and 80 percentage in preterm babies during the first week of life and is a common cause of mortality and morbidity in newborns  The yellowish discoloration of sclera and skin of a newborn is due to the breakdown of hemoglobin It can

be physiological or pathological Physiological Neonatal Hyperbilirubinemia occurs on the second day of life due to several causes like physiological polycythemia shorter life span of RBC reduced hepatic uptake conjugation and excretion of bilirubin or increased enterohepatic circulation Pathological Neonatal hyperbilirubinemia occurs within the first day of life due to Rh incompatibility ABO incompatibility deficiency of G6PD enzyme hypothyroidism or sepsis 

If Neonatal hyperbilirubinemia is not treated it may lead to kernicterus and encephalopathy causing irreversible brain damage Phototherapy is the gold standard in management of neonatal hyperbilirubinemia however  it has significant complications  It can hinder breast milk secretion interfere with mother child bonding and also cause loose stools hydration and electrolyte imbalance bronze baby syndrome retinal damage and parent anxiety in the short term The long term complications include impotency DNA damage leading to melanoma and skin cancer and allergic diseases like asthma and atopic dermatitis  Thus there is a need to find an alternative for reducing the use of phototherapy

In Ayurveda Kamala is a Pittaja Nanatmaja Vyadhi as well as a Rakta Pradoshaja Vikara

Even though there is no chapter dedicated to Navajatha Sishu Kamala we get scattered references The clinical features of Kamala described in Kashyapa Samhitha Vedana Adhyaya are similar to the features of neonatal hyperbilirubinemia  The main cause for kamala is Pittaja Stanya Dusti which causes yellowish discoloration Therefore Pitta Shamana is the choice of treatment for Kamala The newborn period is an age where Shodana karmas like Virechana are contraindicated Thus palliative care can be provided

Triphaladi arka is one such shamana aushadi mentioned in the Ashtanga Sangraha and Ashtanga Hrudaya in the context of Pittaja Stanya Dusti Chikitsa 

Triphaladi arka consist of six drugs namely Triphala  Bhoonimba Musta and Katurohini Triphala has Pitta Hara and Anulomana Properties It can be used for treating Kamala in newborns because of its unique combination that is Amalaki which has Sheeta Virya and Madhura Vipaka and Haritaki and Vibhitaki which have Kashaya Rasa and Madhura Vipaka Katurohini and Bhoonimba have Yakrut Roga Hara 

properties Bhoonimba due to Tikta Rasa and Musta and Katuki due to Sheeta Virya and Tikta Rasa act as Pitta Shamaka

In brief Triphaladi Arka contains drugs with Pitta Kapha Hara and Anulomana properties which break down the pathogenesis of Navajatha Kamala In this study we will evaluate the efficacy of Triphaladi Arka in neonatal hyperbilirubinemia

Arka Preparation is a special preparation method Compared to other drug forms it is more potent and palatable with a longer shelf life and faster action Arka kalpana of Triphala etc will therefore help to preserve all the volatile active principles of the drugs and can be administered in smaller doses making it the ideal dosage form for newborn babies 

 
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