Study of vitamin K2-7 (MK-7) in patients with diabetic peripheral neuropathy and/ or megaloblastic anaemia

An open labeled study of vitamin K2-7 (MK-7) in patients with diabetic peripheral neuropathy and/ or megaloblastic anaemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/08/002930

Enrollment

Registered

2012-08-29

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.

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult male and non-pregnant female patients of the age group 18-60 years 2.Confirmed diagnosis of vitamin B12 deficiency and/or Diabetes Mellitus including pre-diabetics as per WHO criteria 3.Clinical and/or laboratory evidence of peripheral neuropathy 4.No history of drug allergy or significant vitamin K intake 5.Willing to give informed consent

Exclusion criteria

Exclusion criteria: 1.Any major systemic illness. 2.Glycosylated hemoglobin more than 9 and Sugar Fasting more than 250 mg% 3.Patient who are on anti coagulant drug 4.Patient who are on any concomitant medication of neurotoxic or anti-peresthetic drug 5.Patient with sever acute illness 6.Person who are addicted to alcohol

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to evaluate the activity and tolerability of vitamin MK-7 in patients of diabetes and Megaloblastic anaemia with peripheral neuropathyTimepoint: Activity and tolerability of vitamin MK-7 in patients of diabetes and Megaloblastic anaemia with peripheral neuropathy after 8 weeks of treatment	—

Secondary

Measure	Time frame
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 interventionTimepoint: 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 8 weeks of treatment	—

Measure

Time frame

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 interventionTimepoint: 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 8 weeks of treatment

—

Countries

India

Contacts

Public ContactDr Yogesh Dound

Viridis BioPharma Pvt. Ltd.

yogesh_dound@yahoo.com02224055608

Outcome results

None listed

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