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CTRI Number  CTRI/2019/06/019548 [Registered on: 06/06/2019] Trial Registered Prospectively
Last Modified On: 25/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Study of vitamin K2-7(MK-7)levels in patients with tingling and numbness due to diabetes and/or vitamin B12 deficiency 
Scientific Title of Study   To measure serum Vitamin K2-7 levels in patients with peripheral neuropathy due to type 2 diabetes mellitus and/ or vitamin B12 deficiency supplemented with Vitamin K2-7 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SLSPL/MENAQUIN7/032019, version 1, dated 26th Feb 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milind Devale 
Designation  Consulting Physician 
Affiliation  Kokan Hospital 
Address  Department of Medicine, Areshwar Building, 1st Floor, Mhada Colony, Kokan Nagar, Jogeshwari East, Mumbai 400060

Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  milinddevale75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Dound 
Designation  Medical Director 
Affiliation  Synergia Life Sciences Pvt Ltd 
Address  Synergia Life Sciences Pvt. Ltd. Medical Department, 6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai

Mumbai
MAHARASHTRA
400 022
India 
Phone  0224055607  
Fax    
Email  yogesh_dound@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashank Jadhav 
Designation  Medical Associate 
Affiliation  Synergia Life Sciences Pvt Ltd 
Address  Synergia Life Sciences Pvt. Ltd. Medical Department, 6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  02224055608  
Fax    
Email  shashank@viridisbiopharma.com  
 
Source of Monetary or Material Support  
Synergia Life Sciences Pvt. Ltd. 6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai-400022 
 
Primary Sponsor  
Name  Synergia Life Sciences Pvt Ltd 
Address  Synergia Life Sciences Pvt. Ltd. 6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai – 400 022, 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 Milind Devale  Kokan Hospital  Department of Medicine, Areshwar Building, 1st Floor, Mhada Colony, Kokan Nagar, Jogeshwari East, Mumbai 400060.
Mumbai
MAHARASHTRA 		 02228374646

milinddevale75@gmail.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: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: D519||Vitamin B12 deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo capsules  Each capsule identical to Vitamin K2-7 capsule to be given two times in a day orally after food for 8 weeks 
Intervention  Vitamin K2-7 Capsules  Each capsule of 100 mcg to be given two times in a day orally after food for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female aged 18 to 65 who are suffering from type 2 diabetes mellitus and/ or vitamin B12 deficiency.
2. Symptomatic diagnosis of neuropathy (>4 on VAS score).
3. Willing to give informed consent
 
 
ExclusionCriteria 
Details  1. Patients who are suffering from any other systemic illness other than type 2 diabetes mellitus or vitamin B12 deficiency.
2. Patients who are on corticosteroids and oral contraceptives
3. Patients with seropositive status.
4. Pregnancy
5. Patients Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
6. Patients who are on coumarin analogues
7. Patients who are on Quinine Hydrochloride
8. History of alcohol. substance abuse or alcoholism, within the previous one year
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to compare the activity and tolerability of Vitamin K2-7 with placebo in patients with peripheral neuropathy and to measure levels of vitamin K2-7 in serum  0 day, 2nd week, 4th week, 8th week, 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
Safety and tolerability; clinical and metabolic variables.  0 day, 2nd week, 4th week, 8th week, 12th week 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 4 
Date of First Enrollment (India)   13/06/2019 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 Sent for publication 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   An open labelled trial will be conducted to compare the safety and efficacy of Vitamin K2-7 (MK-7) in patients with peripheral neuropathy due to type 2 diabetes mellitus and/ or vitamin B12 deficiency. In this trial, 20 patients will be selected as per the inclusion and exclusion criteria after the approval of Ethics Committee and written informed consent is signed. Each patient will either receive vitamin K2-7 capsule or identical placebo. Blood investigations and clinical examination will be done at every visit. The peripheral neuropathy symptoms were checked at 0 day, 2nd week, 4th week, 8th week and 12th week of visit and will be entered in pain score diary. The gradation of peripheral neuropathy was judged by physician based on visual analogue scale. 10 ml blood was withdrawn on 0 day, 4th week and at 8th week and transferred in a cold chain at -65 ± 10°C to Synergia Life Sciences Pvt. Ltd. for analysis of Vitamin K2-7.  
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