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CTRI Number  CTRI/2014/12/005316 [Registered on: 19/12/2014] Trial Registered Retrospectively
Last Modified On: 21/07/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of Nerve Disease(e.g.numbness,burning etc.) due to Diabetes. 
Scientific Title of Study   A Clinical Comparative study of Shilajatu Vataka and Gokshuradi Guggulu in the Management of Diabetic Polyneuropathy 
Trial Acronym  SVGGDP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramachandra Nisargi 
Designation  PhD Scholar 
Affiliation  IPGT and RA JAMNAGAR Gujarat 
Address  Dr Ramachandra Nisargi D no 619 New Kantharaj Urs Road Kuvempu nagar Mysore
Dr Ramachandra Nisargi PhD Scholar Dept of Kayachikitsa IPGT and RA JAMNAGAR Gujarat
Mysore
KARNATAKA
570023
India 
Phone  09480441972  
Fax    
Email  drramji_nisargi@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alankruta Dave 
Designation  Asso. Professor 
Affiliation  IPGT and RA JAMNAGAR Gujarat 
Address  HOD DEPT OF KAYACHIKITSA IPGT AND RA GAU JAMNAGAR GUJARAT 361008 India
HOD DEPT OF KAYACHIKITSA IPGT AND RA GAU JAMNAGAR GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9824171817  
Fax    
Email  alankruta@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alankruta Dave 
Designation  Asso. Professor 
Affiliation  IPGT and RA JAMNAGAR Gujarat 
Address  HOD DEPT OF KAYACHIKITSA IPGT AND RA GAU JAMNAGAR GUJARAT 361008 India
HOD DEPT OF KAYACHIKITSA IPGT AND RA GAU JAMNAGAR GUJARAT 361008 India
Chitradurga
GUJARAT
361008
India 
Phone  9824171817  
Fax    
Email  alankruta@yahoo.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 
 
Primary Sponsor  
Name  IPGT AND RA GAU 
Address  IPGT AND RA GAU JAMNAGAR 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramachandra Nisargi  Department of Kayachikitsa  OPD no.21 Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 Jamnagar GUJARAT
Jamnagar
GUJARAT 
9480441972

drramji_nisargi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IPGT and RA Jamnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients having Diabetes with Neuropathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gokshuradi Guggulu  Gokshuradi Guggulu, 500 mg, 2 tablet BD with warm water, After food x 8 wks. 
Intervention  Shilajatu Vataka  Shilajatu Vataka, 500 mg, 2 tablet BD with warm water, After food x 8 wks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  1) Patient age below 40 years and above 70 years.
2) Patients with other metabolic & endocrine disorders.
3) Patients suffering from HIV, TB etc, infectious diseases.
4) Patients having any other malignancies, any other serious illnesses.
5) Patients with uncontrolled diabetes.
6) 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.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
rather than just   upto present study  
 
Secondary Outcome  
Outcome  TimePoints 
rather than just  upto present study  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/05/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   www.ayujournal.org 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Diabetic Mellitus (DM) is a most widespread disease in existence. As the civilization developed, lifestyle disorders evolved as a negative effect. Diabetes has got  a prime  place among them according to WHO, an  estimated 285  million people  of world’s adult  population, live with Diabetes Mellitus  till 2010, The  number is expected to be 438 million by 20301. In India alone, the prevalence of diabetes is expected to increase from 31.7 million in 2000 to 79.4 million in 20302. WHO has declared India as the “Diabetic capital of the World”3.

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

Neuropathy develops in 28% to 55% of patients with diabetes mellitus6, The prevalence of diabetic neuropathy has been estimated as high as 62% of diabetics based on subjective complaints, 55% by signs and 100% by nerve conduction studies7. The prevalence 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 and hypercholesteromia are all considered independent risk factors for diabetic neuropathy9. Recent studies in patients with impaired glucose tolerance provide important insights in to the role of the degree of glucose dysmetabolism in the development of neuropathy10.

The American Academy of Family Physicians (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 spreading towards the trunk, It usually presents with sensory symptoms, which range from numbness(“deadness”) to severe pain. Burning, alterations of temperature sensation, parathiasias, and shooting, or stabbing pains are common. Pain may worsen especially at night. And in other hand, it decreases the quality of life of the patients11. These conditions are thought to result from diabetic micro vascular injury involving small blood vessels that supply nerves (Vasanervorum) in addition to the macro vascular complication that can culminate in DPN. All these are the result of metabolic derangements contributing to Hyperglycemia, which in turn causes increased production of superoxide, as a result of oxidative stress. Due to excessive production superoxide, the enzymes like superoxide dismutase etc., fail to neutralize. Thus their excess accumulation, contribute to neuronal ischemia by activating the four major pathways of hyperglycemic damage.

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

In Prameha, the manifestation of the disease to a mild or severe form is dependant mainly on the degree ofDoshadushyaSammurchana by the Nidan12Madhumeha, is one of the Vataja pramaeha, which involves three Doshas andDasha Dushyas, where Chakrapani explains the involvement of all these Dushyasare seen from the initial stage of Sampraptiitself13.As the disease progresses the involvement of Dushyaslike Majja get evident to a greater extent. The excess of Medainvolvement in the very pathogenesis attributed to the excess increase of  Bahudrava Kapha in Madhumeaha due toGunasadharmyata14 and thereby excess Abaddhameda. Abaddhameda results in medodhatwagnimandya, which in turn leads to uttarottara dhtu15 kshaya, 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 diverse etiologies 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 a suitable Ayurvedic Medicine to manage the Diabetic  polyneuropathy  Neuropathy (DPN). By keeping this in view, the present study is planned to segregate the pathology of this malady by the drugs, which possesses pramehaghna, kaphamedahara, srotoshodhana andRasayana property.

Shilajatu vataka16, prepared after giving bhavana to shilajatu, from the kashaya of kutaj, triphala, nimbi, patola, musta and sunthi. These drugs possess chhedana, medoghna, Neuro protective, Rasayana property, Mutradoshahara quality where as Gokshuradi Guggulu17 contains Gokshura and Guggulu are the main drugs possess the kaphamedahara, srotoshodhana, pramehaghna, and Rectifies the vata, hence their action in Diabetic Polyneuropathy will be clinically evaluated.

 
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