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CTRI Number  CTRI/2016/11/007499 [Registered on: 25/11/2016] Trial Registered Retrospectively
Last Modified On: 13/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study
Study of vitamin K2-7 (MK-7) in patients with tingling and numbness due to diabetes and / or vitamin B12 deficiency 
Scientific Title of Study   An Open labeled Multicentre Trial 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 megaloblastic anaemia 
Secondary IDs if Any
Secondary ID  Registry 
VBP–VITAMIN K2-7 (MK-7)-PN /15 Ver 1 dt 6/6/2015  Protocol Number 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name  Dr Vrinda Kulkarni 
Address  Dr. A. L. Nair Road Mumbai Central Mumbai

Phone  02223027000  
Email  kulkarnivrinda585@gmail.com  
Details Contact Person
Scientific Query
Name  Dr Yogesh Dound 
Address  6/10 Jogani Industrial Complex V. N. Purav Marg Chunabhatti

Phone  02224055607  
Email  yogesh_dound@yahoo.com  
Details Contact Person
Public Query
Name  Dr Yogesh Dound 
Address  6/10 Jogani Industrial Complex V. N. Purav Marg Chunabhatti

Phone  02224055607  
Email  yogesh_dound@yahoo.com  
Source of Monetary or Material Support
Viridis BioPharma Pvt. Ltd. 6/10, Jogani Industrial Complex, V N Purav Marg, Chunabhatti. Mumbai 400 022 
Primary Sponsor  
Name  Viridis BioPharma Pvt Ltd 
Address  6/10, Jogani Industrial Complex, V.N. Purav Marg, Chunabhatti, Mumbai – 400 022, India 
Type of Sponsor  Pharmaceutical industry-Indian 
Details of Secondary Sponsor  
Name  Address 
Countries of Recruitment     India  
Sites of Study
No of Sites = 2  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Vrinda Kulkarni  B Y L Nair Charitable Hospital  Department of Haematology, OPD No. 30, OPD Building, Dr. A. L. Nair Road, Mumbai Central Mumbai - 400008
Dr Milind Devale  Kokan Hospital  Areshwar Building, 1st Floor, Mhada Colony, Kokan Nagar, Jogeshwari East, Mumbai 400060

Details of Ethics Committee
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Inter System BioMedica Ethics Committee  Approved 
Regulatory Clearance Status from DCGI  
Not Applicable 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neuropathy occuring because of Megaloblastic Anaemia, Type 2 Diabetes Mellitus 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
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 megaloblastic anaemia.
2.Symptomatic diagnosis of neuropathy (>4 on VAS score).
3.Willing to give informed consent. 
Details  1.Patients who are suffering from any other systemic illness other than type 2 diabetes mellitus or megaloblastic anaemia.
2.Patients who are on corticosteroids and oral contraceptives
3.Patients with seropositive status.
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   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome
Outcome  TimePoints 
The primary objective of the study is to evaluate the activity and tolerability of Vitamin K2-7 in patients with peripheral neuropathy.  Activity and tolerability of vitamin MK-7 in patients of diabetes and Megaloblastic anaemia with peripheral neuropathy after 12 weeks of treatment. 
Secondary Outcome
Outcome  TimePoints 
Safety and tolerability; clinical and metabolic variables.  The secondary objective will be sharply focused on the role of vitamin MK-7 in ameliorating the residual neuropathy symptoms after adequate correction of the underlying inciting event. A record will be maintained of some of the features such as hyper pigmentation, muscle cramps and fatigue for any effect of the intervention after 12 weeks of treatment 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/08/2015 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Recruitment Status of Trial (Global)
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  

Recent preliminary open labeled observational study conducted by Vaidya et al shows that daily oral dose of 100 mg for 3 months is associated with a reduction in the frequency, intensity, and duration of cramps. In an open labeled study conducted by Kulkarni et al, it was shown that vitamin K2-7 at a dose of 100 mcg twice a day for 8 weeks was well tolerated and safe with a therapeutic activity for the symptoms of peripheral neuropathy.

Based on the results of these studies, the next study which is a follow up study in larger cohort is planned to address the peripheral neuropathy experienced by the patients.


Evaluation parameters: Efficacy, tolerability and safety of Vitamin K2-7.