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 Modification(s)	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 Modification(s)	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) Modification(s)	Name  Dr Vrinda Kulkarni  Address  Dr. A. L. Nair Road Mumbai Central Mumbai Mumbai MAHARASHTRA 400008 India  Phone  02223027000   Fax     Email  kulkarnivrinda585@gmail.com
Details Contact Person Scientific Query	Name  Dr Yogesh Dound  Address  6/10 Jogani Industrial Complex V. N. Purav Marg Chunabhatti Mumbai MAHARASHTRA 400022 India  Phone  02224055607   Fax     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 Mumbai MAHARASHTRA 400022 India  Phone  02224055607   Fax     Email  yogesh_dound@yahoo.com
Source of Monetary or Material Support Modification(s)	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  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	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 Mumbai   02223027000 02223072663 vrindaklr@yahoo.com  Dr Milind Devale  Kokan Hospital  Areshwar Building, 1st Floor, Mhada Colony, Kokan Nagar, Jogeshwari East, Mumbai 400060 Mumbai   02228374646 drshashank.jadhav@rediffmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Inter System BioMedica Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  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.
ExclusionCriteria	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. 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	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome Modification(s)	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 Modification(s)	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" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	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. N=100 Evaluation parameters: Efficacy, tolerability and safety of Vitamin K2-7.