Efficacy of Dalk-i-Mutadil with Roghan-i-Laqwa versus Gabapentin in Distal Symmetric Polyneuropathy (DSPN) of Diabetic Origin - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Visual analogue scale
研究概览
简要总结
Purpose: To evaluate the Efficacy of Dalk Mu‘tadil with Roghan-i-Laqwa in DSPN.
Design: Open, Randomized, Controlled Clinical Trial
Study Intervention: Test group: Dalk-i-Mu‘tadil with Roghan-i-Laqwa for 20 min for 30 days
Control group: Gabapentin (300 mg/day) for 30 days
Main outcome measures:
Primary outcome: Visual analogue scale, Vibration perception threshold (VPT)
Secondary outcome: Michigan neuropathy screening instrument , Chronic Acquired Polyneuropathy Patient-Reported Index (CAPPRI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patients of Distal Symmetrical Peripheral Neuropathy (DSPN) either by Type 1 or type 2 diabetes mellitus (HbA1c less than 9.5 percent) Patients of either gender Patients older than 20 years and less than 60 years of age.
排除标准
- •ï‚· Pregnancy and lactation.
- •ï‚· Patients of peripheral neuropathy other than the Diabetic origin.
- •ï‚· Patients of DSPN due to Diabetes Mellitus having HbA1c more than 9.5% ï‚· Currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device.
- •ï‚· Pathological state such as cardiovascular diseases, renal diseases, and hepatic diseases (having abnormal Serum bilirubin, Serum creatinine, Blood urea, AST, ALT and ECG).
- •ï‚· Any localized skin lesion over the legs (where integrity of skin is compromised) ï‚· Unwillingness or inability to comply with the requirements of the protocol.
结局指标
主要结局
Visual analogue scale
时间窗: 0th, 15th, 30th
Vibration perception threshold (VPT)
时间窗: 0th, 15th, 30th
ï‚· Michigan neuropathy screening instrument
时间窗: 0th, 15th, 30th
ï‚· Chronic Acquired Polyneuropathy Patient-Reported Index (CAPPRI)
时间窗: 0th, 15th, 30th
次要结局
- No Secondary Outcome
- No Secondary Outcome(N/A)
研究者
Dr Irshad Ahmad Wani
National Institute of Unani Medicine