| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:P599||Neonatal jaundice, unspecified. Ayurveda Condition: KAMALA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Control Group | Routine New Born Care | | 2 | Intervention Arm | Drug | Classical | | (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 |