FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/10/021716 [Registered on: 18/10/2019] 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   Effect of NRL/2019/5PNV to promote health and wellbeing in healthy adults  
Scientific Title of Study   Randomized control trial to assess the efficacy and safety of NRL/2019/5PNV with micronutrient fortification to promote health and wellbeing in healthy adults  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/19-20/006 Ver 1.0   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjit Sisode 
Designation  Consultant 
Affiliation  Janseva Hospital 
Address  Janseva Hospital, 1st floor, OPD 1, Datta Mandir Chowk, Dhule- 424001.

Dhule
MAHARASHTRA
424001
India 
Phone    
Fax    
Email  manjit.sisode8888@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  Dr 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 Manjit Sisode  Janseva Hospital  Janseva Hospital,1st floor, OPD 1, Datta Mandir Chowk, Dhule- 424001.
Dhule
MAHARASHTRA 
9850001222

manjitsisode8888@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
College of Ayurved and Research Center, Akurdi Pune 44  Approved 
College of Ayurved and Research Center, 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 micro nutrient fortification 
Intervention  NRL/2019/5PNV   Protein supplement with micro nutrient fortification 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age group: 18 years - 65 years
BMI in the range of 20-26
Subjects will be incorporated as per 75% male and 25% female ratio
Subjects in good physical condition and sound mental status.
In the judgment of the Principal Investigator, able to comply with protocol requirements.
Subjects willing to sign written informed consent
Willingness to abstain from use of vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.
 
 
ExclusionCriteria 
Details  Allergies to ingredients in product/ milk
Subjects with uncontrolled and uncomplicated diabetes (HbA1C NMT 7.0 % and blood pressure NMT 140/90 mm hg) may or may not be on prescription.
Subjects with past history of addiction abuse and rehabilitation
Subject more than 2 events of alcohol consumption per week
Subjects with current medical history of any major illness such as cancer, heart disease, COPD , Asthma etc. in the past
Subjects with history of any acute or chronic illness that may affect the patient’s participation in the study
Use of prescription medications and/or nonprescription medications for weight loss.
Subjects with acute illness or history of major or minor surgery in the past one year.
Female subjects who are currently pregnant and/or breast feeding
Subjects not willing to participate in study
 
 
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 
Changes in Daily activity questionnaire
Changes in Endurance levels (steppers test)
Changes in Perceived stress levels
Changes in Immunity via number of events of recurrent UTI/RTI etc.
Changes in Anthropometric analysis
Changes in HbA1c and glycemic profile ie blood sugar levels
Changes in Regulation of lipid levels
 
From baseline to end of study 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28)
Changes in digestive behavior assessment
Changes in mood behavior
Changes in Safety parameters by LFT, RFT and thyroid profile etc.
Changes in Assessment of Overall Improvement by subject and investigator
Changes in Adverse events
Changes in sleep quality questionnaire
Changes in Palatability with dosage compliance of test product
 
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 2/ Phase 3 
Date of First Enrollment (India)   22/10/2019 
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)?  

Response - NO
Brief Summary  

After Ethics committee’s approval, clinical study will be registered on CTRI website. Both male and female subjects of age between 18 to 65 years of age (both inclusive) attending outpatient department of study site(s) will be screened for eligibility criteria. The recruitment will be done in ratio of 75:25% Male to female respectively.

On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject’s demographic details will be taken. Subject will undergo clinical 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). Subject’s vitals will be recorded. The subject will be considered for further evaluation as per the inclusion and exclusion criteria.

Subject’s blood sample will be collected at the respective study centers for laboratory testing i.e. CBC, ESR, Hb%, Thyroid function test, Liver Function Tests, Lipid Profile, Renal Function test, Random sugar, HbA1cUrine Routine tests will be done. During screening visit and the entire study duration subjects will be advised to refrain from antioxidant agents, vitamins, anti-inflammatory    drugs,    hormones,   Nutraceutical, Ayurvedic,    Siddha,    Unani,  herbal /homeopathic medicines.

On baseline visit, subject will be recruited in the study if he or 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. Subjects will be asked for occurrence of any adverse event during screening period. Subject will undergo clinical examination. Subject’s vitals will be recorded. Subject’s Daily activity, Endurance levels, Perceived stress levels and number of events of recurrent UTI/RTI etc. will be recorded. Subject’s Anthropometric analysis will be performed. Following questionnaires will be assessed like Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28), digestive behavior assessment, mood behavior, sleep quality questionnaire.

 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 ‘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 her concomitant medication other than antioxidant agents, weight loss management, vitamins, anti-inflammatory drugs, hormones, Nutraceutical, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines etc. The record of concomitant medication will be kept in the CRF.

 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 vitals will be recorded. Subject’s Daily activity, Perceived stress levels and number of events of recurrent UTI/RTI etc. will be recorded. Subject’s Anthropometric analysis will be performed. Following questionnaires will be assessed like Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28), digestive behavior assessment, mood behavior, sleep quality questionnaire.

 On third follow up visit (i.e. Day 90) Subject’s Daily activity, Endurance levels (steppers test), Perceived stress levels and number of events of recurrent UTI/RTI etc. will be recorded. Subject’s blood sample will be collected at the respective study centers for laboratory testing i.e. CBC, ESR, Hb%, Thyroid function test, Liver Function Tests, Lipid Profile, Renal Function test, Random sugar, HbA1cUrine Routine tests will be done. Subject’s Anthropometric analysis will be performed. Subject will be assessed for applicable biochemical analysis and safety parameters. Following questionnaires will be assessed like Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28), digestive behavior assessment, mood behavior, sleep quality questionnaire. Subject’s safety biochemical parameters along with the clinical examination will be performed. Adverse events will be critically evaluated. 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.

 Global assessment of overall improvement will be done by subject 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.


 
Close