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临床试验/CTRI/2025/03/082532
CTRI/2025/03/082532招募中3 期

An Open Labelled Randomised Active Controlled Evaluation of Sarivadi Lauha in the Management of Diabetic Neuropathy

Principal Parul Institute of Ayurved1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
56
试验地点
1
主要终点
Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patient of Diabetic neuropathy on the basis of Biothesiometer and Michigan Neuropathy Screening Instrument

研究概览

简要总结

Diabetes Mellitus (DM) is a systemic metabolic disease that causes abnormally high levels of blood sugar. It occurs when the body doesn’t produce enough insulin or the patient has developed insulin resistance. The burden of diabetes is high and increasing globally, and in developing economies like India, mainly fueled by the increasing prevalence of obesity and unhealthy lifestyles. The estimates in 2019 showed that 77 million individuals had diabetes in India, which is expected to rise to over 134 million by 2045. The prevalence of diabetes in India has risen from 7.1% in 2009 to 8.9% in 2019. Currently, 25.2 million adults are estimated to have impaired glucose tolerance, which is estimated to increase to 35.7 million in the year 2045. The complications of diabetes mellitus can be distinguished into acute and chronic complications.

The Acute Complication of DM include –

Diabetic ketoacidosis and Diabetic coma, Hypoglycemia due to incorrect dose of medication and sudden lifestyle and diet changes, Hyperglycemia

The Chronic Complications of DM include –

Macroangiopathy: Coronary artery disease, cerebrovascular complication, peripheral vascular disease, Diabetic renovascular disease.

Microangiopathy: Diabetic retinopathy, Diabetic nephropathy, Diabetic neuropathy, Diabetic foot.

Diabetic neuropathy is a serious diabetes complication that may affect as many as 50% of people with diabetes. However, it can be often prevented or progress can be slowed with consistent blood sugar management and a healthy lifestyle. There was no direct reference available for diabetic neuropathy. As per Ayurvedic principals there is involvement of  Vata and Pitta Dosa in DN. Symptoms like Suptata(numbness), Daha(burning sensation) in Hastapad (hands-feet) are described in Purvarupa of Prameha. Daha is also mentioned in Upadravas(complication) of Prameha. Which shows close resemblance with signs and symptoms of DN. Prameha Updrava are – Trushna(Thirst), Atisara(Diarrhea) ,Jwara(Fever) , Daha(Burning Sensation), Durbalata(Weakness), Aruchi(Anorexia), Avipaka(Indigestion). In diabetic neuropathy, micro and macrovascular changes and neuronal ischemia are the important steps in the pathology that can be compared with Raktadusti and Vatadusti which lead to Paddah, Hastpad Suptata. This pathology and symptoms are similar to Vatarakta. In Phalashruti of Sarivadi Lauha  it is indicated in  Pramehapidika, Vatarakta ,Arsha, Twaggda. Recent researches in Ayurveda have proved efficacy of various herbal and herbomineral drugs in DN. Drugs like Ashwangha, Amlaki, Guduchi, Shilajatu etc were evaluated through preclinical and clinical studies but still effective management is not available for DN.

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
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1 Known case of Diabetes Mellitus with clinical signs and symptoms of Diabetic neuropathy (Tingling/Pricking/Burning/Numbness) 2 Patient with good to moderate glycemic control 3 Known case of Diabetes mellitus with MNSI Questionnaire score of greater than or equal to 7 and MNSI Examination score of greater than or equal to 2.
  • 4 Patient showing altered vibration perception on the basis of biothesiometer.
  • 5 Nerve condution velocity showing the altered velocity of selected nerves in diabetes patients.

排除标准

  • Known case of vitamin B12 deficiency. 2 Patients who present with alcohol abuse. 3 Known cases of autoimmune diseases; including Sjogren’s syndrome, lupus, rheumatoid arthritis, vasculitis and Para neoplastic disorders, and any other SOL-causing nerve dysfunction. 4 Known cases of infection.
  • Leprosy, HIV, STDs, and hepatitis B and C. 5 Known cases of uncontrolled Hypertension. 6 Known cases of Parkinsonism and any other nerve degenerative disorders.7 Patients with known allergy to any drug ingredients of study medicine in the trial group and control group.

结局指标

主要结局

Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patient of Diabetic neuropathy on the basis of Biothesiometer and Michigan Neuropathy Screening Instrument

时间窗: Baseline, day 15, day 30, day 45, day 60, day 75 and day 90

次要结局

  • Compare the efficacy of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic neuropathy on the basis of symptoms observed in patients(Baseline, Day 15, Day 30, day 45, Day 60, Day)
  • Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic(neuropathy on the basis of Nerve Conduction Velocity Test( In 7 patient of each group))
  • Compare the safety of Sarivadi Lauha and Pregabalin+ Methylcobalmine on the basis of adverse events and biochemical parameters –haemogram, renal and hepatic function test, urine routine and microscopic and glycosylated hemoglobin.(Adverse events on Day 15, Day 30, Day 45, Day 60, Day 75 and Day 90)

研究者

发起方
Principal Parul Institute of Ayurved
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Patel Denilkumari Nileshkumar

Parul Institute of Ayurved

研究点 (1)

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