Health Condition 1: null- Neuropathy occurring because of vitamin B12 deficiency and type 2 Diabetes Melitus
Conditions
Sponsors
Synergia Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
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 neuropathyTimepoint: Activity and tolerability of vitamin MK-7 in patients of diabetes and Vitamin B12 deficiency 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 | — |
Countries
India
Contacts
Public ContactDr Yogesh Dound
Synergia Life Sciences Pvt Ltd
Outcome results
None listed