Summery Of the Study

Diabetic Peripheral Neuropathy is a type of nerve damage that can occcur with diabetes and is most common complication of diabetic mellitus with a lifetime prevalence of about 50-70%.patients of diabtes will lose their sensation in the feet,burning sensation and weakness along with pain.Neuropathy is a coomon complication of diabetes mellitus patient affecting approximately 305.although the invention of insulin and hypogycemia have done a great service for diabetes,yet these patients dont get a proper solution for their neuropathic complications.

The Drugs Used conventionally are mostly for relief in the symptoms and moreover they have certain side effects so it is necessary to explore the possibilities of safer and effective treatment from other sources

The Symptomology correspomding to the clinical presentation of Diabetic Peripheral Neuropathy is scattered in purvaroopa,lakshana,upadrava of Prameha,Vatarakta,Vatavyadhi,Jwara,Pandu.

Madhutailika Basti as it is indicated in Prameha,acts as Deepana,Bramhana,Atyanta Vrushya,Balavarnakara,Upadrava Rahita and Rasayana.

Siravyadha Relieves Suptivata,Padadaha,Padaharsha,Vatashonita. and Whenthere is a pathology of vatarakta along with ruja ,daha,toda,supti asraksravya is indicated.

Vatari Rasa is Vatakapha rogahara,and indicated in Vatarakta,Prameha,Shula,Vatavyadhi.

Shilajatu Rasayana is Sarvapramehahara.

Madhumeha and Diabetic Peripheral Neuropathy are big challenges in medical practice.the research question will more focusing on madhumeha upadrava chikitsa by raktashodhana,basti to control neurovascular integrity and rasarasayana has any positive effect in Diabetic Peripheral Neuropathy on correct evidence based clinical kayachikitsa parameters.hence the presence study entitled

AN OPEN LABELLED RCT STUDY ON ASESSMENT OF COMBINED EFFICACY OF SIRAVYADHA,MADHUTAILIKA BASTI,VATARI RASA AND SHILAJATU RASAYANA IN THE MANAGEMENT OF DIABETIC PERIPHERAL NEUROPATHY(MADHUMEHA UPADRAVA)

OBJECTIVES OF STUDY

1.To Study The Effect Of Siravyadha,Madhutailika Basti,Vatari Rasa,Shilajatu Rasayana In The Managemnt of Diabetic Peripheral Neuropathy.

2.To Asess The Effect Of Modern On Going Intervention In The Management Of Diabetic Peripheral Neuropathy.

3.To Compare The Effect Of Siravyadha,Madhutailika Basti,Vatari Rasa And Shilajatu Rasayana Over Modern On Going Intervention In The Management Of Diabteic Peripheral Neuropathy

STUDY DESIGN

Study Design-Randemised,Standerd Controll,Open And Comparative

Estimated Enrollment-40

Allocation-Randemised

Masking-Open

Study Duration-42 Days

Follow Up After-15 Days

ASSESSMENT CRITERIA

On The Basis Of Subjective And Objective Criteria

Subjective Criteria

1.RUJA(Grade 0=does not complaint of nerve pain,no nerve pain even when asked about it,Grade 1=complaint of nerve pain even when not asked about it,Grade 2=complaint of severe nerve pain and points to the areas of its radiation.the pain does not interfere with sleep.it is aggravated by repeated use of the limb such as manual labour,tailoring etc,Grade 3=says pain is severe,and that it interferes with sleep,the patient keeps the limb in apposition of rest and avaoids its movement

2.HASTAPADA SUPTATA(Grade 0=parasthesia and /decreased tendon reflexs,Grade1 =severe parasthesia and/mild weakness,Grade 2=intolerable parasthesia amd/marked motor loss,Grade 3=paralysis)

3.HASTAPADA DAHA(Grade 0=no burning sensation,Grade 1=occassionally burning sensation,Grade 2=often burning sensation,Grade 3=always burning sensation(disturbing sleep and other activities)

4.Dourbalya(Grade 0=no sign or symptoms,Grade 1=asymptomatic,weakness on examination and testing normally,Grade 2=symptomatic,weakness interfering with function but not interfering ADL,Grade 3=weakness interfering with ADL,Grade 4=life threatening /disabling(paralysis))

5.CHIMICHIMAYANA(Grade 0=none,Grade 1=symptoms from toes to midfoot,not including heel,Grade 2=symptoms from midfoot to ankle,Grade 3=symptoms extend above ankle to knee without upper extremity symptoms,Grade 4=symptoms above knee/concurrent lower and upper extremity symptoms)

Objective Criteria

1.A Standard TORANTO Clinical Scoring System Is Selected For Asessing The Peripheral Neuropathy

2.NCS(Nerve Conduction Study)( Based On Symptom Score,Reflexes,Sensory Test Score,Result)

3.Vitamin B12

4.CRP

5.HBA1C

INVESTIGATION

1.HB%,TC,DC,ESR,CRP,PT INR

2.FBS,PPBS,HBA1C

3.LIPID PROFILE

4.NCS

5.EMG

6.VITAMIN B12

OVERALL ASESSEMENT

Marked/Very Good Improvement--Above 75% Improvement

Moderate/Good improvement--50-75% Improvement

Mild Improvement--25-50% Improvement

Very Mild Improvement--Below 25%

No Improvement At All----0%