Study of vitamin K2-7(MK-7)levels in patients with tingling and numbness due to diabetes and/or vitamin B12 deficiency
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complicationsHealth Condition 2: D519- Vitamin B12 deficiency anemia, unspecified
- Registration Number
- CTRI/2019/06/019548
- Lead Sponsor
- Synergia Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to compare the activity and tolerability of Vitamin K2-7 with placebo in patients with peripheral neuropathy and to measure levels of vitamin K2-7 in serumTimepoint: 0 day, 2nd week, 4th week, 8th week, 12th week
- Secondary Outcome Measures
Name Time Method Safety and tolerability; clinical and metabolic variables.Timepoint: 0 day, 2nd week, 4th week, 8th week, 12th week