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CTRI Number  CTRI/2025/06/089086 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomized clinical study to evaluate efficacy and safety of Nutrify Genies Capsule v/s commercially available Vitamin B12 in preventing diabetic neuropathy in participants who have type 2 diabetes.  
Scientific Title of Study   A randomized, open label, clinical trial to investigate efficacy and safety of NG02 in preventing the progression of diabetic neuropathy in type 2 diabetes patients.  
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 Sagar S Mandlik  
Designation  Consultant Physician and Critical Care Specialist  
Affiliation  Vakratund Hospital Pvt. Ltd 
Address  Vakratund Hospital Pvt. Ltd, Raghukul Sankul Behind Hotel Bandhuraj Mumbai Agra National Highway Pathardi Phata Nashik Nashik MAHARASHTRA 422010 India

Nashik
MAHARASHTRA
422010
India 
Phone  9225343885  
Fax    
Email  sagarmandlik007@yahoo.com   
 
Details of Contact Person
Scientific Query  
Name  Mr Ayan Neogi  
Designation  Managing Director  
Affiliation  Vivforever 
Address  103 A Bhairavi Doordarshan CHS Gokuldham Goregaon East Mumbai Mumbai MAHARASHTRA 400063 India

Mumbai
MAHARASHTRA
400063
India 
Phone  9967968612  
Fax    
Email  ayanneogi@vivforever.in   
 
Details of Contact Person
Public Query  
Name  Mr Ayan Neogi  
Designation  Managing Director  
Affiliation  Vivforever 
Address  103 A Bhairavi Doordarshan CHS Gokuldham Goregaon East Mumbai Mumbai MAHARASHTRA 400063 India


MAHARASHTRA
400063
India 
Phone  9967968612  
Fax    
Email  ayanneogi@vivforever.in   
 
Source of Monetary or Material Support  
NuToday Private Limited  
Vakratund Hospital Pvt. Ltd, Raghukul Sankul Behind Hotel Bandhuraj Mumbai Agra National Highway Pathardi Phata Nashik Nashik MAHARASHTRA 422010 India  
 
Primary Sponsor  
Name  NuToday Private Limited  
Address  PG 51 05, MGM Apartments, Chikalasandra, Bangalore, Karnataka - 560061  
Type of Sponsor  Other [Neutraceutical] 
 
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 Sagar S Mandlik  Vakratund Hospital Pvt. Ltd   Vakratund Hospital Pvt. Ltd, Department of Neurology & General Medicine 1st Floor,Raghukul Sankul Behind Hotel Bandhuraj Mumbai Agra National Highway Pathardi Phata Nashik Nashik MAHARASHTRA 422010 India
Nashik
MAHARASHTRA 		 9225343885

sagarmandlik007@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Navsanjeevani Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NG02  Nutrify Genies formula to prevent the progression of diabetic neuropathy in type 2 diabetes patients for 6 months. 
Comparator Agent  Vitamin B12  Commercially available Vitamin B12 Capsule for 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Subject should be diagnosed with Type 2 Diabetes Mellitus for a duration of at least 1 year with HbA1c 6%-12% & a score of more than 50% on DN4 questionnaire.
2. Subject should be diagnosed with Mild to Moderate Diabetic Neuropathy for a duration of at least 6 months.
3. Subject is ready to sign the informed consent. 
 
ExclusionCriteria 
Details  1. Subject is not ready to sign the informed consent.
2. ect has major systemic diseases such as malignancy, connective tissue disorders, liver, and renal diseases or any other illness which according to investigator forbids him/her from participating in this clinical trial.
3. Subjects having Neuropathic pain from anything other than diabetes.
4. Subjects who have participated in any clinical study in less than a month before the screening visit.
5. Pregnant or breast-feeding female subjects. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To compare the mean change from baseline scores in the Total Symptom Score (TSS) between the two groups over the treatment period.
2. To compare the mean change from baseline scores in The Douleur Neuropathique 4 (DN4) questionnaire between the two groups over the treatment period.
3. To compare the mean change from baseline levels of Malondialdehyde biomarker between the two groups over the treatment period.
4. To compare the mean change from baseline levels of Nerve Growth Factor between the two groups over the treatment period.
 		 Day 1( baseline), Month 2, Month 4 & Month 6. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the improvement of Quality of Life (QoL) from baseline based on Diabetes Quality of Life Questionnaire (DQOL) questionnaire.   Day 1( baseline), Month 2, Month 4 & Month 6. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/06/2025 
Date of Study Completion (India) 15/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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   Nutrify Genie’s formula contains Alpha Lipoic Acid, Emblica Officinalis std., Beta-Glucogallin, Methylcobalamin, Thiamine, Magnesium, Quaterfoilic, and Zinc. These ingredients offer Anti-inflamatory and Anti-oxidant support and hence help in Nerve support. They have been shown to offer support in improving Diabetic Neuropathy by alleviating oxidative stress, helping to inhibit aldose reductase enzyme. They also help to maintain healthy sugar balance. 
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