CTRI/2022/03/041503已完成未知
An Open Label, Single Arm, Study to Assess the Efficacy and Safety of Menaquinone-7 (Vitamin K2-7) in Subjects with Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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