A Clinical Study on Diabetic Peripheral Neuropathy and Comparative Evaluation of Habb-e-Azaraqi With Standard Control in its Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement In Vibration
研究概览
简要总结
Diabetes mellitus and its complications are a major and growing global health problem, and diabetic neuropathy is among the most significant and troublesome microvascular complications, causing considerable morbidity and burden on quality of life.
Diabetic peripheral neuropathy is the most common form and can progress to serious outcomes such as foot ulceration, gangrene, and amputation; current therapies may reduce symptoms but do not prevent disease progression, creating a need for safe and effective treatment options. In this context, the Unani formulation Habb-e-Azaraqi (used for wajaulasab) is proposed for evaluation on scientific parameters in diabetic peripheral neuropathy. This study is planned as an open randomized standard controlled clinical trial with 60 patients (30 test, 30 control), recruited from Moalajat/Modern Medicine OPD/IPD and referrals at Ajmal Khan Tibbiya College and Hospital (AMU, Aligarh). The test group will receive Habb-e-Azaraqi (1 tablet twice daily after meals) for 60 days, while the control group will receive Methylcobalamin 750 mcg + Pregabalin 75 mg (1 tablet once daily) for 60 days. Efficacy will be assessed using subjective symptoms and objective measures including vibration perception threshold (VPT), 10 g monofilament test, and Toronto Clinical Neuropathy Score, with follow-ups on days 0, 15, 30, 45, and 60 (key objective measures at baseline and day 60).
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed patients of diabetic peripheral neuropathy with Type 2 diabetes mellitus through TCNS.
- •Patients between the age of 30 to 60 years of age.
- •Patients of either sex.
- •Controlled case of Type 2 diabetes mellitus either by drug or life style modification.
- •Fasting blood sugar less than or equal to 150 or HbA1c less than or equal to
- •Patients willing to participate in the study and follow the instructions.
排除标准
- •Patients below 30 years and above 60 years of age.
- •Uncontrolled case of diabetes mellitus.
- •HbA1c greater than
- •Physiological status: pregnancy and lactation Pathological status: cardiovascular diseases, renal diseases, hepatic diseases, thyroid dysfunction.
- •Complications of diabetes mellitus other than diabetic peripheral neuropathy.
- •Causes of neuropathy other than diabetes.
- •Patient having ischaemic or neuropathic ulcer.
- •Patients taking neurotoxic drugs.
- •Clinically suspected cases of compressive neuropathy.
- •Any comorbid condition.
- •Alcoholics.
- •Severe loss of vibration sensation.
- •VPT value greater than 25 volts.
- •Patients who refuse to give written consent for the study and who fail to follow up.
结局指标
主要结局
Improvement In Vibration
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Perception Threshold Value
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Grade 0 No Loss Of Vibration
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Perception-Complete
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Improvement
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Grade 1 Borderline Loss Of
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Vibration Perception-Slight
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Improvement.
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Grade 2 Mild Loss Of
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Vibration Perception-Partial
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Grade 3 Moderate Loss
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Vibration Perception-No
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
Improvement In The Score For
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
10 Gram Monofilament.
时间窗: Assessment Of Vibration Perception | Threshold Through Drp At Initiation Of | Study (0 Day) And At The End Of Study (60 | Days). | 10 Miligram Monofilament Test At | Initiation Of The Study (0 Day) And At The | End Of Study (60 Days).
次要结局
- Improvement In The Subjective Parameters:(Loss Of Light Touch And Temperature)
研究者
Tabi Idris Siddiqui
Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh