Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Menaquinone-7 (Vitamin K2-7) Capsules,: One capsule two times per day orally for 8 Weeks
Control Intervention1: NIL: NIL
Sponsors
Synergia Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subjects with age 18 to 65 years of age( both inclusive) 2. Subjects with known case of Type 2 Diabetes Mellitus (on regular and stable medication from last 3 months). 3. Subjects presenting with symptoms of impaired peripheral neuropathy defined by bilateral decreased or absent reflexes at the ankles, or bilateral decreased vibration, pinprick, fine touch or temperature perception in the distal lower extremities; and confirmed by nerve conduction velocity (NCV) studies. 4. Subjects with symptomatic diagnosis of peripheral neuropathy with pain severity score of ( >4 on VAS score). 5. Subjects who are willing to sign informed consent for participation in
Exclusion criteria
Exclusion criteria: 1. Subjects with history of diabetic foot ulcers (Wagner Grade =1) or lower extremity amputation, diabetic amyotrophy, or non-diabetic cause of lower limb neuropathy 2. Any condition that may lead to confusion of the diagnostic of painful DPN, in particular amputations other than fingers/toes-, not diabetic neurological disorder and skin conditions that may affect sensation at the painful limbs. 3. Subjects who are unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study 4. Subjects who are on corticosteroids and oral contraceptives within 2 weeks of screening visit 5. Subjects who are on coumarin analogues or Quinine Hydrochloride within 2 weeks of screening visit 6. Subjects with Hepatic impairment defined as Serum Bilirubin, SGOT or SGPT > 2 x upper limit of normal (ULN) 7. Subjects with impaired renal function defined as either serum creatinine level > 2 mg/dL or requiring hemodialysis 8. Subjects with uncontrolled hypertension at screening (sitting systolic >160 mmHg and/or sitting diastolic >90 mmHg 9. Subjects with current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s) 10. Subjects with Congestive heart failure Class III or IV of the New York Heart Association (NYHA) 11. Subjects with serious or unstable coronary heart disease, hepatic, kidney, respiratory, hematological alterations, problems with peripheral vascular disease, or other medical or psychiatric conditions that can put in risk the participation of the subject in the study. 12. Subjects with Glycosylated haemoglobin (HbA1c) greater than (=) 10 percent at screening 13. Subjects with history of hypersensitivity to the drugs in the study or drugs with similar chemical structures 14. Subjects with arthritis, sciatic, fibromyalgia, restless leg syndrome, non-neuropathic muscle-skeletal pain or back chronic pain 15. Subjects who are Pregnant or Breast feeding. 16. Subjects with history of alcohol. substance abuse or alcoholism, within the previous one year 17. Subjects Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summed change in sensory NCV from baseline of the bilateral sural , proximal and distal median sensory nervesTimepoint: 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the individual NCVs.Timepoint: 8 Weeks;Change from baseline in the individual nerve amplitudes.Timepoint: 8 Weeks;Change from baseline in the individual nerve latency.Timepoint: 8 Weeks;Change from baseline in the serum Osteocalcin (cOC and ucOC) levels.Timepoint: 8 weeks;Change from baseline in the serum Vitamin K2-7 levels.Timepoint: 8 weeks;Change in VAS scale as assessed from the baseline to end of the study.Timepoint: 8 Weeks;The assessment of safety of Investigational Product will be based on the frequency of Adverse Events.Timepoint: 8 Weeks | — |
Countries
India
Contacts
Public ContactDr Shashank S Jadhav
Biosphere Clinical Research Pvt.Ltd
Outcome results
None listed