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临床试验/CTRI/2024/04/065099
CTRI/2024/04/065099尚未招募2 期

Therapeutic evaluation and efficacy of Ḥijāma bilā shārt and Asbī Ūnānī formulation in the management of Diabetic Peripheral Neuropathy

Hakim Syed Ziaul Hasan Government Unani Medical College and College1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Machigan neuropathy instrument

研究概览

简要总结

Diabetic Peripheral Neuropathy  (DPN) is the most common complication of Diabetes Mellitus (DM) with a lifetime prevalence of about 50%. The prevalence of peripheral neuropathy in individuals with diabetes mellitus depends on the duration of the disease;  clinically, and up to 80% of those who have had the disease for more than 15 years.  Diabetic peripheral neuropathy in type 2 diabetes mellitus may affect the all part of the nervous  system but  most affected is symmetric neuropathy in which segmental demyelination, schwann cell injury, and axonal damage,that involves distal sensory and motor nerves. Individuals with the neuropathy develop decreased sensation in the distal extremities with less evident motor abnormalities. The loss of pain sensation can result in the development of ulcers, which heal poorly because of the diffuse vascular injury in diabetes and are a major cause of morbidity.The pathogenesis of neuropathy is unknown  but it may be due to accumulation of sorbitol and fructose as a result of hyperglycaemia, leading to deficiency of myoinositol . The condition is significantly associated with age, duration of disease, daistolic blood pressure, smokers, low HDL cholesterol level and high LDL level and HBA1C .

pathological feature include axonal Several types of polyneuropathies are seen in long-standing and poorly-controlled cases of DM. of both myelinated and unmyelinated fibres. With the thickening of Schwann cell basal lamina. Patchy segmental demyelination and abnormal intraneural capillaries, ( with basement membrane thickening and microthrombi) . Diabetic neuropathic pain is characterised by  tingling, burning, sharp , shootingand lacinating or even as electrical shock sensations. These Features are also seen in of kidrTreatment of peripheral neuropathies should focus on the treatment of the underlying disease process. For example, glucose control in diabetic neuropathies can be with membrane stabilizers, certain anti-epileptics, and tricyclic antidepressants.FDA has approved 3 medications for the pain with DPN (Pregablin, Duloxetine, Tapentadol) but none affords complete relief

In unani  system of medicine the concept of diabetes neuropathy is not mentioned in classical literature but it has been described under the caption of khidr, sun hona  (sunbhari), Warme asab  and zofe asaab .  there is related symptoms are available  the pathogenesis of disease is attributed to three factors: Temperament (Mizaj), Structure (Tarkeeb) and continuity (Ittesal), abnormalities in any of these factors are considered as temperamental disarrangement (Sue Mizaj in Arabic), Structural disarrangement (Sue Tarkeeb) and discontinuity (Taffaruq e Ittesal ) respectively.According to Rhazes obstruction of nerves occur due to the accumulation of viscous substances (Imtila of Galeez Akhlat). It is said that frequent exposure of nerve to cold due to excess intake of water, excess sleep, more sexual intercourse, and taking a bath after meals, etc. can lead to the accumulation of toxic matter (fuzlat) in nerves. Ultimately, it results in weakness of nerves (Zoafe- Asaab ) and impairs nerve conduction like in Khadar. Moreover, viscous humour (Galeez Khilt) also obstructs small vessels that supply nutrients to nerves. This results in the disturbance of nerve conduction. When continuous exposure to cold accompanies with nerve weakness, it increases the chance for the dysfunction of nerves as seen in the early stage of neuropathy and with chronicity, symptoms like numbness and loss of sensation appear. Diabetic neuropathy can be treated on par with the principles of khadar along with the drugs possessing properties like a hypoglycaemic, analgesic, anesthetic, nervine tonic, anti­inflammatory, anti-oxidants, etc. Usool-e-ilaj is Izala-e­sabab by controlling glycemic level, Tanqiya-e-mawad by Istifragh (evacuation) and Tadil-e-mizaj by Taskheen (to provide warmth). Accordimg to unaletrature khadar or Zoafe asaab can be treated by tanqiyae mawad by hijama.  Nerves  are also apart of brain therefore Hijama Bila shurt will Applyon calf and ankle region.

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
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient with diabetes mellitus type 1 and type 2.stable blood glucose level less than 200mg/dl.
  • that is HBsAg less than 9%
  • patients complain of pain in foot, burning and tingling sensation.

排除标准

  • patients less than 25 years and above 60 years 2.Pregnant and lactating women 3.History of malignancy and tumour.
  • 4.Other causes of neuropathy 5.Any spinal diseases 6.Skin lesions or skin allergy.

结局指标

主要结局

Machigan neuropathy instrument

时间窗: 0 day and 30th day

Vibration perception threshold

时间窗: 0 day and 30th day

次要结局

  • Pain in feet(tingling and burning sensation)

研究者

发起方
Hakim Syed Ziaul Hasan Government Unani Medical College and College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Simran Khan

Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.)

研究点 (1)

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