Health Condition 1: E539- Vitamin B deficiency, unspecified
Conditions
Interventions
Intervention1: B29(Vitamin B12): Injection: B29 AQ PFS (Vitamin B12) (6 injection in 2 weeks) followed by Oral Tablet Vit B12 as prescribed dosage for 10 weeks
Control Intervention1: Nil: Nil
Sponsors
Corona Remedies Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients having moderate to severe peripheral neuropathy with Biothesiometer score 19 volts or more 2. Vitamin B12 levels should be below 200 pg per mL or 148 pmol per L 3. Patients willing for follow up at scheduled visits as per protocol at the same centre
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have any of the following: 1. Patients with known hypersensitivity or severe allergic reactions to Vitamin B12. 2. Pregnant and lactating women. 3. Patients who are currently participating in another clinical trial or have participated in any other clinical study involving Vitamin B12 or related treatments within 30 days prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Vibration Perception Threshold (VPT)Timepoint: 4 weeks & 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pain Severity (VAS Score) Change in Pain Severity in Diabetic population Change in PGA score using GCI scale Safety assessment for Common Adverse eventsTimepoint: 4 weeks & 12 weeks | — |
Countries
India
Contacts
Public ContactKalpana Sharma
Zyfis Lifesciences Private Limited
Outcome results
None listed