跳至主要内容
临床试验/CTRI/2014/12/005316
CTRI/2014/12/005316已完成不适用

A Clinical Comparative study of Shilajatu Vataka and Gokshuradi Guggulu in the Management of Diabetic Polyneuropathy

IPGT AND RA GAU1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年8月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
rather than just

研究概览

简要总结

Diabetic Mellitus (DM) is a mostwidespread disease in existence. As the civilization developed, lifestyledisorders evolved as a negative effect. Diabetes has got  a prime place among them according to WHO, an  estimated 285  millionpeople  of world’s adult  population, live with DiabetesMellitus  till 2010, The  number is expected to be 438 million by20301. In India alone, the prevalence of diabetes is expected toincrease from 31.7 million in 2000 to 79.4 million in 20302. WHO hasdeclared India as the “Diabetic capital of the Worldâ€3.

Neuropathy means nerve disease ordamage. Diabetic Neuropathy is nerve damage by diabetes. This is of threekinds, Autonomic, Focal and Peripheral neuropathy. Diabetic peripheralneuropathy (DPN), a micro vascular complication of diabetes, is one the mostcommon forms of neuropathic pain. Neuropathic pain4 as definedby the International Association for the Study of Pain*,is pain initiated orcaused by a primary lesion or dysfunction in the nervous system.* Neuropathiesare classified as symmetrical or asymmetrical (focal or multifocal) involvingeither the proximal or distal limb. The distal symmetrical DPN is common form,and is known by multiple names including Diabetic sensor motor peripheralneuropathy or distal symmetric diabetic peripheral neuropathy5.Around 3.2 million deaths every year are attributable to complication ofdiabetes mellitus.

Neuropathy develops in 28% to 55% ofpatients with diabetes mellitus6, The prevalence of diabeticneuropathy has been estimated as high as 62% of diabetics based on subjectivecomplaints, 55% by signs and 100% by nerve conduction studies7. Theprevalence of diabetic mellitus increases with time and poor glycemic control8,prevalence may depend impart upon patient age, which itself is a risk factor.Cigarette smoking, alcohol consumption, hypertension, height andhypercholesteromia are all considered independent risk factors for diabeticneuropathy9. Recent studies in patients with impaired glucosetolerance provide important insights in to the role of the degree of glucosedysmetabolism in the development of neuropathy10.

The American Academy of FamilyPhysicians (AAFP)  reports that this is characterized by Distal,bilateral, symmetrical, loss of sensation in a “stocking – glove†pattern,affecting the longest nerves first, starting with toes and feet, and spreadingtowards the trunk, It usually presents with sensory symptoms, which range fromnumbness(“deadnessâ€) to severe pain. Burning, alterations of temperaturesensation, parathiasias, and shooting, or stabbing pains are common. Pain mayworsen especially at night. And in other hand, it decreases the quality of lifeof the patients11. These conditions are thought to result fromdiabetic micro vascular injury involving small blood vessels that supply nerves(Vasanervorum) in addition to the macro vascular complication that canculminate in DPN. All these are the result of metabolic derangementscontributing to Hyperglycemia, which in turn causes increased production ofsuperoxide, as a result of oxidative stress. Due to excessive productionsuperoxide, the enzymes like superoxide dismutase etc., fail to neutralize.Thus their excess accumulation, contribute to neuronal ischemia by activatingthe four major pathways of hyperglycemic damage.

The direct comparison of Diabeticneuropathy is not available in Ayurvedic texts. On review of previous researchworks, many scholars have coined this disease by various names such asMadhumehaJanyaUpadrava,TwakgataVata, Jhinjhinivata, Vatanadi Pradhana Shotha etc., Theexplanation of symptoms are scattered in the Purvarupa and Upadravas ofMadhumeha.

In Prameha, themanifestation of the disease to a mild or severe form is dependant mainly onthe degree ofDoshadushyaSammurchanaby the Nidan12Madhumeha,is one of the Vataja pramaeha, which involves three DoshasandDashaDushyas, where Chakrapani explains the involvement of all these Dushyasareseen from the initial stage of Sampraptiitself13.As thedisease progresses the involvement of Dushyaslike Majjagetevident to a greater extent. The excess of Medainvolvement in thevery pathogenesis attributed to the excess increase of  BahudravaKaphain Madhumeaha due toGunasadharmyata14andthereby excess Abaddhameda. Abaddhameda results in medodhatwagnimandya,which in turn leads to *uttarottara dhtu15kshaya,*ie.,affecting the formation of  majjadhatu. As a result,further Vataprakopa, due to excessive Dhatukshaya,which initiates the nerve injury.

DM is caused by spectrum of diverseetiologies resulting in Chronic Hyperglycemia and complication attribute to it.Principally this is a metabolic disorder with variable clinical manifestation  and progression, majority of the cases are detected after the manifestation of complications.

Here is an attempt to find out asuitable Ayurvedic Medicine to manage the Diabetic  polyneuropathy Neuropathy (DPN). By keeping this in view, the present study is planned tosegregate the pathology of this malady by the drugs, which possessespramehaghna, kaphamedahara, srotoshodhanaandRasayana property.

Shilajatu vataka16, prepared after giving bhavana toshilajatu, from the kashaya of kutaj, triphala, nimbi, patola, musta andsunthi. These drugs possess chhedana, medoghna, Neuro protective, Rasayanaproperty, Mutradoshahara quality where as Gokshuradi Guggulu17 containsGokshura and Guggulu are the main drugs possess the kaphamedahara,srotoshodhana, pramehaghna, and Rectifies the vata, hence their action inDiabetic Polyneuropathy will be clinically evaluated.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex, age group, above 40yrs and below 70yrs.
  • Metabolically stable Type 2 Diabetic with symptomatic diabetic sensorimotor polyneuropathy (DSPN) who are with or without medications (modern medications like Metformin, Thiazolidinediones, Alpha glucosidase inhibitors, Sulphonilureas, Meglitinides, Incretin etc.) 3)Both freshly detected as well as previously treated cases will be included for the study.
  • Presence of classical signs and symptoms Madhumeha.
  • Patients with Diabetic Neuropathy having N1a, N2a and N2b grading will be included for the study.

排除标准

  • Patient age below 40 years and above 70 years.
  • Patients with other metabolic & endocrine disorders.
  • Patients suffering from HIV, TB etc, infectious diseases.
  • Patients having any other malignancies, any other serious illnesses.
  • Patients with uncontrolled diabetes.
  • Patients with diabetic wounds / ulcers.
  • Patients with complications like Diabetic nephropathy, Diabetic keto acidosis & Diabetic coma.
  • Patients with Diabetic Neuropathy N0 and N3 will be excluded from the study.

结局指标

主要结局

rather than just

时间窗: upto present study

次要结局

  • rather than just(upto present study)

研究者

发起方
IPGT AND RA GAU
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验