Study of vitamin K2-7 (MK-7) in patients with tingling and numbness due to diabetes and / or vitamin B12 deficiency

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/11/007499

Enrollment

100

Registered

2016-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Neuropathy occuring because of Megaloblastic Anaemia, Type 2 Diabetes Mellitus

Interventions

Intervention1: Vitamin K2-7 Capsules: Each capsule of 100 mcg to be given two times in a day orally after food for 8 weeks. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to evaluate the activity and tolerability of Vitamin K2-7 in patients with peripheral neuropathy.Timepoint: Activity and tolerability of vitamin MK-7 in patients of diabetes and Megaloblastic anaemia with peripheral neuropathy after 12 weeks of treatment.	—

Secondary

Measure	Time frame
Safety and tolerability; clinical and metabolic variables.Timepoint: 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	—

Measure

Time frame

Safety and tolerability; clinical and metabolic variables.Timepoint: 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

—

Countries

India

Contacts

Public ContactDr Yogesh Dound

Viridis BioPharma Pvt. Ltd.

yogesh_dound@yahoo.com02224055607

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026