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CTRI Number  CTRI/2020/03/024403 [Registered on: 31/03/2020] Trial Registered Prospectively
Last Modified On: 31/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Mango Tender Leaves In Newborn Jaundice 
Scientific Title of Study   A Randomized Controlled Clinical Study On Efficacy Of Amra Pallava In Navajata Kamala w.s.r. To Neonatal Jundice 
Trial Acronym  APNJ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namrata 
Designation  PG SCHOLAR 
Affiliation  Sri Sri College Of Ayurvedic Science and Research 
Address  OPD No-9, Department of PG Studies Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura
OPD No-9, Department of PG Studies Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura
Bangalore Rural
KARNATAKA
560082
India 
Phone  9740060298  
Fax    
Email  namrata19katwate@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Diyasri R A 
Designation  Professor 
Affiliation  Sri Sri College Of Ayurvedic Science and Research 
Address  OPD No-9, Department of PG Studies Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura
OPD No-9, Department of PG Studies Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura
Bangalore Rural
KARNATAKA
560082
India 
Phone  9448939421  
Fax    
Email  divya_mesha@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr NAMRATA 
Designation  PG SCHOLAR 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 
Address  Department of PG Studies Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura
Department of PG Studies Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura
Bangalore Rural
KARNATAKA
560082
India 
Phone  9740060298  
Fax    
Email  namrata19katwate@yahoo.com  
 
Source of Monetary or Material Support  
Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura, Banglore-560082 
 
Primary Sponsor  
Name  Sri Sri College Of Ayurvedic Science And Research 
Address  21ST KM, Kanakapura Road, PO-Udayapura, Banglore-560082 
Type of Sponsor  Private medical college 
 
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 Divyasri RA  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH  OPD No-9 ,Department of PG Studies Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research, 21ST KM, Kanakapura Road, PO-Udayapura
Bangalore Rural
KARNATAKA 		 9448939421

divya_mesha@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P969||Condition originating in the perinatal period, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amra Pallava with Narikela Jala  Tender leaves of Amra(Mango) will be collected, washed, dried in shade and made into churna(powder) form. Fresh and adequate quantity of Narikela jala(tender coconut water) will be collected. 125mg Amra pallava churna will be subjected to bhavana(triturition) with quantity sufficient Narikela jala & made in a form of Pishti(paste). This will be given to Newborn satisfying Inclusion Criteria for three times in a day for 5 days. Follow-up will be done on 2nd and 4th day after completion of treatment. Treatment Duration- 5days Duration Of Study-7days 
Comparator Agent  Phototherapy  The naked infant will be placed under double surface phototherapy unit, with the light source at a distance of about 45cm from the skin. During the treatment, the eyes will be shielded to prevent retinal damage and genital area will be covered with a diaper. The position of the infant will be changed frequently to expose all parts of the skin to the light. It will be given for 5days or till Serum Bilirubin level reduces to less than 12mg/dl 
 
Inclusion Criteria  
Age From  2.00 Day(s)
Age To  1.00 Month(s)
Gender  Both 
Details  (a)Age of onset of jaundice after 2 days of birth.
(b)Physiological jaundice.
(c)Birth weight above 2000gms.
(d)Serum bilirubin level from 12mg/dl-16 mg/dl.
(e)Neonates whose parents give consent for the trial.
 
 
ExclusionCriteria 
Details  (a)Age of onset less than 2 days of birth.
(b)VLBW & ELBW babies.
(c)Serum bilirubin level less than 12mg/dl and more than 16 mg/dl.
(d)All types of Pathological jaundice, Neonatal Sepsis & other systemic illness.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The Bilirubin Level Would Be Reduced To Optimum Levels By Giving This Medicine For 5 days   5 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Baby would be saved from harmful effects of Phototherapy  5 days  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   01/04/2020 
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="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be submitted in UGC approved journals 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Neonatal period extends from birth till 28 days of life. Neonatal Jaundice is found in 1st week of life.Over 2/3rd of Newborn babies develop Clinical jaundice during early days of life. Nearly 60% of term and 80% of pre-term babies are seen to be jaundiced. The yellowish discoloration of skin in Neonatal Jaundice is of great concern for parents.

Neonatal Jaundice are of two types:-Physiological Jaundice & Pathological Jaundice. Neonatal jaundice is caused by increased levels of Unconjugated Bilirubin in the blood which is toxic to the developing Central Nervous System and if left untreated, can cause Neurological Sequalae. The Increased levels of Unconjugated Bilirubin in the body can cross the blood brain barrier, thus, maintaining the levels of Bilirubin in the body within safe limits is important in order to obviate the need for  Exchange Blood Transfusion.

Prophylactic Phototherapy is done (if Serum Bilirubin exceeds 12mg/dl) in several cases to prevent complications. There are certain cases of exaggerated Physiological Jaundice which may be prolonged and requires intervention.

In Ayurveda, several drugs have been mentioned for Kamala Chikitsa in children, but their role in Neonatal Jaundice, the effect on bilirubin conjugation and safety needs to be evaluated. One such drug is Amra Pallava to alleviate Kamala in children. 

Though Phototherapy is considered as safe and effective modality of treatment in Neonatal Jaundice, there are few complications with Phototherapy. Thus, there is a need to find an alternative modality of treatment for Phototherapy which is safe and cost-effective.

Hence, this study is an effort in this regard to evaluate the effect of Amra pallava in Neonatal jaundice.

 
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