| 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
|
|
|
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
|
|
|
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, HbA1c. Urine 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, HbA1c. Urine 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. |