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CTRI Number  CTRI/2019/11/021993 [Registered on: 13/11/2019] Trial Registered Prospectively
Last Modified On: 16/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial of NRL/2019/5PNK to promote growth, health and wellbeing in children. 
Scientific Title of Study   Randomized control trial to assess the efficacy and safety of NRL/2019/5PNK with micronutrient fortification to promote growth, health and wellbeing in children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/19-20/008 Ver 1.0 dated 4th September 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidyadhar Kumbhar 
Designation  Consultant 
Affiliation  Sunad Ayurved 
Address  Ground floor, OPD 1, Wolf Colony, Chinchwad- Pune 33

Pune
MAHARASHTRA
411033
India 
Phone    
Fax    
Email  dr.vidyadhar24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Omkar Kulkarni 
Designation  Senior Manager, Research and Development 
Affiliation  Netsurf Research Labs Pvt Ltd 
Address  107, Plot 2, Laxman Nagar, Baner Road, Baner, PUNE 411045 (Maharashtra) India.

Pune
MAHARASHTRA
411045
India 
Phone    
Fax    
Email  omkar.kulkarni@nrl.net.in  
 
Details of Contact Person
Public Query
 
Name  Ms Priya Khare 
Designation  Senior Manager, Research and Development 
Affiliation  Netsurf Research Labs Pvt Ltd 
Address  107, Plot 2, Laxman Nagar, Baner Road, Baner, PUNE 411045 (Maharashtra) India.

Pune
MAHARASHTRA
411045
India 
Phone    
Fax    
Email  priya.khare@netsurfnetwork.com  
 
Source of Monetary or Material Support  
Netsurf Communications Pvt Ltd, 107, Plot 2, Laxman Nagar, Baner Road, Baner, PUNE 411045 (Maharashtra) India. 
 
Primary Sponsor  
Name  Netsurf Communications Pvt Ltd 
Address  107, Plot 2, Laxman Nagar, Baner Road, Baner, PUNE 411045 (Maharashtra) India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Vidyadhar Kumbhar  Sunad Ayurved  First floor, OPD 1, Wolf colony, Chinchwad, Pune 33
Pune
MAHARASHTRA 
9960075536

dr.vidyadhar24@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
College of Ayurved and Research Centre, Akurdi Pune 44  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health And well being 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Marketed Product  Protein supplement with micronutrient fortification 10 gm in 150 ml once in morning for 90 days 
Intervention  NRL/2019/5PNK  Protein supplement with micronutrient fortification 10 gm in 150 ml once in morning for 90 days 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Children Aged 06 - 11 years inclusive (both gender)
Consent: Understanding of the study and willingness to participate as evidenced by subject’s
parents and/or legal guardian’s voluntary written informed consent.
Compliance: Understands and is willing, able and likely to comply with all study procedures
and restrictions. 
 
ExclusionCriteria 
Details  Subject has a known allergy or intolerance to the study product or ingredients or is on a
special diet and cannot consume the study product
Subject has a current illness requiring hospitalization
Subject has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the
study
Subject is currently taking medication that could affect absorption/metabolism of study
product or weight of the child. Exception: Topical/ocular steroids will be permitted during the
study
Subject is diagnosed with recurrent respiratory infections due to cystic fibrosis,
immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital
lung and ciliary abnormalities, an unsuspected foreign body and asthma. (As per history and
documentation in the medical records)
Subject has active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history and documentation in the medical records) as per discretion of investigation
Subject has a history of diabetes mellitus (as per history and documentation in the medical
records)
Subject has been on antibiotic therapy within the last one month before start of the study
(before study Day 1)
Subject has dysphagia, aspiration risk, and difficulty in swallowing due to acquired /
congenital abnormalities that would hamper oral intake of the study product. (As per history and
documentation in the medical records)
Subject has a clinically significant nutritional deficiency requiring specific treatment with any
other nutritional supplement (not study product) as diagnosed by the investigator. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in weight (WHO z-score)
Change in Anthropometric parameters
Change in Blood biochemical tests - Serum iron, Serum calcium
Questionnaire for evaluation of development and behaviour like- Motor activity, Cognition, memory skills, social skills , Attention and concentration, Over activity and impulsivity, Perception of space and directions, Concepts of time, Perception of visual forms and figures, Passivity/inactivity and Planning/organizing etc
Change in Cardiopulmonary performance
 
From baseline to end of study 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Immunity profile
Change in appetite score
Emotional Quotient Questionnaire
Changes in Liver Function test, Renal Function Test, Blood glucose, HbA1C, Thyroid Function Test, CBC etc.
Change brain derived neuronal factor levels
Adverse events
Assessment of Overall Improvement by parent and investigator
Palatability with dosage compliance
 
From baseline to end of study 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 1/ Phase 2 
Date of First Enrollment (India)   12/11/2019 
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="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After Ethics committee’s approval, clinical study will be registered on CTRI website. Children subjects of age between 06 to 11 years of both sex (inclusive) attending outpatient departments/consultation department of study site (s) will be screened for eligibility criteria. On screening visit, a written informed consent will be obtained from subject’s guardian/parents for their participation in the study. Subject’s demographic details will be taken. Subject will undergo clinical examination (general and systemic examination). Subject’s medical, surgical and treatment history will be taken. Subject’s current medication if any will be noted in the case record from (CRF). The subject will be considered for further evaluation as per the inclusion and exclusion criteria. Subject will be called next day morning on empty stomach for laboratory testing. Subject’s blood sample will be collected at the respective study centers for laboratory testing i.e. CBC, ESR, Hb%, Liver Function Tests, Renal Function test, HbA1c etc. Subject’s Urine Routine will be done. During screening visit and the entire study duration subjects will be advised to refrain from antioxidant agents, vitamins, health supplements, Nutraceuticals, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines. A screening window of 14 days will be kept, in case if there is delay in availability of tests reports or in case few tests need to be repeated. Subject will be called for baseline visit assessment (day 0). On baseline visit, subject will be recruited in the study if he/she meets all the inclusion criteria. Subjects will then be randomized to one of the two study groups as per the computer generated randomization list. Subject’s parent/ guardian will be asked for occurrence of any adverse event during screening period. Subject will undergo clinical examination (general and systemic examination). Subject’s growth- change in weight (WHO z-score), anthropometric parameters and blood biochemical tests - Serum iron, Serum calcium will be assessed. The questionnaire for evaluation of development and behavior like- Motor activity, Cognition, memory, social skills , Attention and concentration, Over activity and impulsivity, Perception of space and directions, Concepts of time, Perception of visual forms and figures, Passivity/inactivity and Planning/organizing etc. and cardiopulmonary performance by VO2, will be assessed. At baseline visit and at every follow up visit (except last follow up visit), as per computer generated randomization list, subjects will be provided with containers each containing 350 gms (300 gms for 30 days + additional 50 gms for use if follow up is delayed maximum up to 5 days) of either ‘Kids Protein Supplement’ or Standard. Subject will be advised to consume given supplement in a dose of 10gms in the morning with 150 ml milk for 3 months. Subject will be advised to continue his concomitant medication other than antioxidant agents, vitamins, health supplements, Nutraceuticals, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines etc. The record of concomitant medication will be kept in the CRF. Product compliance will be assessed by the investigator on every follow up visit. Subjects who continuously misses dosing for >3 consecutive days or total missed dose > 9 days during the study period will be treated as drop outs. Subjects will be allowed to come for follow up either 5 days prior or after the scheduled follow up visit, provided subject should continue the given treatment. Subjects will be called at respective study sites for follow up visits after every month up to 3 months after the baseline visit. On every follow up visit, Subject will undergo clinical examination. Subject’s growth- change in weight (WHO z-score), anthropometric parameters will be assessed. The questionnaire for evaluation of development and behavior like- Motor activity, Cognition, memory, social skills , Attention and concentration, Over activity and impulsivity, Perception of space and directions, Concepts of time, Perception of visual forms and figures, Passivity/inactivity and Planning/organizing will be assessed. Subject’s immunity profile no. of recurrent acute Upper Respiratory tract infection (URTI), no. of sick days per month will be assessed by the presence of any acute URTI, No. of days required to recover from episode of infection will be recorded. Subject’s change in appetite score, emotional Quotient Questionnaire will be assessed. On third follow up visit (i.e. Day 90) subject’s growth- change in weight (WHO z-score), anthropometric parameters and blood biochemical tests - Serum iron, Serum calcium will be assessed. The questionnaire for evaluation of development and behavior like- Motor activity, Cognition, memory, social skills , Attention and concentration, Over activity and impulsivity, Perception of space and directions, Concepts of time, Perception of visual forms and figures, Passivity/inactivity and Planning/organizing etc. and cardiopulmonary performance by VO2, will be assessed. Subject’s immunity profile no. of recurrent acute Upper Respiratory tract infection (URTI), no. of sick days per month will be assessed by the presence of any acute URTI, No. of days required to recover from episode of infection will be recorded. Subject’s change in appetite score, emotional Quotient Questionnaire will be assessed. Global assessment of overall improvement will be done by subject’s parent and investigator on last follow up visit. Palatability with dosage compliance will be assessed by the investigator and by subject of test product from baseline to end of the study. All the subjects will be closely monitored for any adverse event starting from baseline visit till the end of the study visit. After completion of 3 months of study treatment, all the subjects will be asked to stop trial medications and take advice of investigator for further treatment.

 
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