Study of vitamin K2-7 (MK-7) in patients with tingling and numbness due to diabetes and / or vitamin B12 deficiency
- Conditions
- Health Condition 1: null- Neuropathy occuring because of Megaloblastic Anaemia, Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2016/11/007499
- Lead Sponsor
- Viridis BioPharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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