CTRI/2019/01/016983招募中不适用
An Open Label Comparative Clinical Study To Assess The Effect Of Dasamoolaksheeradhara As An Add On Therapy With Standard Care In Conventional Medicine In Diabetic Neuropathy
Dr Anjaly NV1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Biothesio Meter
研究概览
简要总结
Diabetic foot accounts for one of the largest inpatients admissions in India. The neuropathies are the most common long-term complications of diabetes,affecting up to 50% of patients. There are many patients even withgood glycemic control and oral medications complaining of neuropathic symptomssuch as burning sensation,numbness etc**.**Dasamoola Ksheeradhara can be used as a cost effective and instantaneous solution to the menaceof Diabetic Peripheral Neuropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of diabetic neuropathy fulfilling the diagnostic criteria.
- •Patients having hemoglobin A1c(HbA1c) >6.5% at screening.
- •Patient having FBS ≤200 mg/dL at screening.
- •Patients currently treated with Standerd care in Modern medicine.
- •Patient willing to give a signed informed consent form prior to start of the study.
排除标准
- •Patient has hypersensitivity to any of the study medications Patient is a nursing mother, Pregnant.
- •Patient has used injected anesthetics or steroids within 30 days of baseline.
- •Known cases of Skinleisons, malignancy,, any non-diabetic neurologic disorders, seriouds health issues Patient has certain conditions that could confound evaluation of DPN, in particular, amputations other than toes, (e.g. phantom limb pain), and skin conditions affecting sensation in painful limbs.
- •Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
- •Patient is in an immunocompromised state.
- •Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
- •Patient has a history of pernicious anemia, untreated hypothyroidism, chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
- •Patient has any other serious medical condition.
结局指标
主要结局
Biothesio Meter
时间窗: Day 1,Day 15,Day 45
次要结局
- Blood Glucose Levels(Day 1,Day 15,Day 45)
- HbA1C(Day 1,Day 45)
- Neuropathy Total Symptom Score,(Day 1,Day 15,Day 45)
- Michigan Neuropathy Screening Instrument(Day 1,Day 15,Day 45)
- Quality of Life using Nottingham health profile(Day 1,Day 15,Day 45)
研究者
研究点 (1)
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