Ayurvedic management of Nerve Disease(e.g.numbness,burning etc.) due to Diabetes.

Completed

Conditions: patients having Diabetes with Neuropathy

Registration Number: CTRI/2014/12/005316

Lead Sponsor: IPGT AND RA GAU

Brief Summary: 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 worldâ€™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 â€œDiabetic 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 â€œstocking â€“ gloveâ€ pattern,affecting the longest nerves first, starting with toes and feet, and spreadingtowards the trunk, It usually presents with sensory symptoms, which range fromnumbness(â€œdeadnessâ€) 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 as*MadhumehaJanyaUpadrava,TwakgataVata, Jhinjhinivata, Vatanadi Pradhana Shotha* etc., Theexplanation of symptoms are scattered in the *Purvarupa* and *Upadravas* of*Madhumeha*.

In *Prameha*, themanifestation of the disease to a mild or severe form is dependant mainly onthe degree of*DoshadushyaSammurchana*by the *Nidan12*. *Madhumeha*,is one of the *Vataja pramaeha*, which involves three *Doshas*and*DashaDushyas*, where Chakrapani explains the involvement of all these *Dushyas*areseen from the initial stage of *Samprapti*itself13.As thedisease progresses the involvement of *Dushyas*like *Majja*getevident to a greater extent. The excess of *Meda*involvement in thevery pathogenesis attributed to the excess increase of *BahudravaKapha*in *Madhumeaha* due to*Gunasadharmyata14*andthereby 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, srotoshodhana*and*Rasayana* property.

*Shilajatu vataka*16, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1)Patients of either sex, age group, above 40yrs and below 70yrs.
2)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.
4)Presence of classical signs and symptoms Madhumeha.
5)Patients with Diabetic Neuropathy having N1a, N2a and N2b grading will be included for the study.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rather than just	upto present study

Secondary Outcome Measures

Name	Time	Method
rather than just	upto present study

Trial Locations

Locations (1): Department of Kayachikitsa
🇮🇳
Jamnagar, GUJARAT, India
Department of Kayachikitsa
🇮🇳Jamnagar, GUJARAT, India
Dr Ramachandra Nisargi
Principal investigator
9480441972
drramji_nisargi@yahoo.co.in