From,

DR.SUKETHA KUMARI,B.A.M.S

Ist yr. M.D. (AYU),

Department of Post Graduate Studies in KayaCikitsā,

Government Ayurveda Medical College,

Mysore- 570021

To,

THE REGISTRAR,

Rajiv Gandhi University of Health Sciences, Karnataka

Bangalore- 41

Through,

The Principal and Head OF THE DEPARTMENT,

Department of Post Graduate Studies in KayaCikitsā,

GovernmentAyurveda Medical College,

Mysore – 570021

Respected Sir,

Sub: Submission of completed Proforma for registration of subject for Dissertation.

I request you to kindly register the below mentioned subject against my name for the submission of dissertation to the Rajiv Gandhi University of Health Sciences, Bangalore, for partial fulfilment of M.D(Ayu) in KayaCikitsā.

Title of TheDissertation

“Clinical Trial to Evaluate the combined effect of TakraDhara and Pushyanuga Churna (internally) in the management of Diabetic Peripheral Neuropathy – An observational study’’

Here with I am enclosing completed proforma for the Registration of subject for dissertation.

Thanking you,

Place: Mysore Your’s faithfully,

Date:

(Dr. SUKETHA KUMARI)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE Dr. SUKETHA KUMARI,

AND ADDRESS :IstM.D. (AYU)

DEPT OF P.G STUDIES IN

KAYACIKITSĀ,

GOVERNMENT AYURVEDA

MEDICAL COLLEGE ,MYSORE

PERMANENT ADDRESS: W/O Dr. LAXMIKANT,

C/O BASAVA NIVAS, #6186/40, HIREMATH COLONY,

Tq: BASAVA KALYAN,

Dt: BIDAR - 585327

2. NAME OF THE INSTITUTE: GOVERNMENT AYURVEDA MEDICALCOLLEGE ,MYSORE - 570021

3. COURSE OF STUDY AND: M.D. (AYURVEDA) IN KAYA CIKITSĀ

SUBJECT

4. DATE OF ADMISSIONTO COURSE:29-OCT-2011

5. TITLE OF THE TOPIC:

“Clinical Trial to Evaluate the combined effect of TakraDharaPushyanugaChurna (internally) in the management of Diabetic Peripheral Neuropathy – An observational study’’

6. BRIEF RESUME OF THE INTENDED WORK:

6.1Need for the study:

Diabetes mellitus is a most widespread disease in existence. As the civilization developed, lifestyle disorders evolved as a negative effect.Among them, Diabetes mellitus occupies the prime place.Diabetes mellitus is caused by spectrum of diverse etiologies resulting in chronic hyperglycemia and complication attributed to it.Principally, this is a metabolic disorder with variable clinical manifestation and progression. Unfortunately, majority of the cases are detected after the complication arises.

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 2030. WHO projects that globally deaths caused by this health problemie, DM increases by 17%.

Diabetic neuropathy is a family of nerve disorder caused by DM.The incidence of getting neuropathy due to DM around the world is 60 – 70% of diabetic patient.Around 3.2 million deaths every year are attributable to complication of diabetes mellitus. i.e six deaths every minute.

The scholars of ayurveda have studied DM in detail and also the description of PramehaRoga described in all authentic ayurvedic texts.After careful and detailed study, analyzed all aspects of both disorders, found many similarities in respect of etiology (Nidana), pathology (Samprapti), symptomatology (Lakshana) and few modalities of treatment (Cikitsa).With these similarities, they have equated Prameha as DM.The features such as KarapadaDaha(burning sensation), Cumcumayana(tingling sensation), Suptata (numbness) aresymptoms seen in PramehaRogi either in prodromal stage or in the actual exhibition stage or in complication stage is identified as Diabetic peripheral neuropathy.Since these symptoms causes much disturbance to the patient for his routine activity of life.It needs to be tackled effectively.

Here is an attempt to find out a suitable management of Diabetic Peripheral Neuropathy with ayurvedic drugs.

6.2) Review of Literature:

  • Detail description of Prameha is found in Brhatryi1& Laghutryi.2
  • Reference of PushyanugaChurna is found in CarakaSamhitaCikitsaSthana, 30th Chapter, Shloka number 90-95.3
  • References of TakraDhara is found in

•AyurvediyaPanchakarmiyaVijnana by VaidyaHaridas Kasture.4

•Panchakarma problems and solutions and principles and practice of Dhara by Dr. M.R. Namboothiri, Dr. L. Mahadevan M. D, and Dr. S. Gopakumar.5

•KeraliyaCikitsaPaddhati – Sri Dharakalpah by Dr. Pavana J. and Dr. Manoj Shankaranarayana.6

  • Detail description of Diabetes Mellitus & Diabetic Neuropathy is found in modern medical science books – Harrison’s Principles of Internal Medicine7, Davidson’s Principles & Practice of Medicine8, Robbins Basic Pathology9, Textbook of medical physiology by Guyton and Hall.10

6.3)Previous works done:

  • Dr Dwivedi K.N - Effect of Dashamula and Jivaniya and BalyaDravya in the management of Diabetic Neuropathy,BHU, Varanasi,1986.
  • Dr Vijaya K – To evaluate the effect of TakraDhara in the management of MadhumehaUpadravawsr to Diabetic Peripheral Neuropathy – An observational study,GAMC, Mysore, 2003.
  • Dr KokaneDeepti – Effect of DashamulaKashayaVasantaKusumakara Rasa in the management of Diabetic Polyneuropathy,AMV, Hubli, 2008.
  • DrVyasarajTantri A – To evaluate the efficacy of shamanaAushadhis in the management of Diabetic Peripheral and Proximal Neuropathy,GAMC, Mysore, 2010.

6.4)Objective of the Study:

  • To evaluate the efficacy of TakraDhara and PushyanugaChurna in the management of diabetic peripheral neuropathy.

7. Materials and Methods:

7.1)Source of data:

Single group of 30 patients coming under inclusion criteria, approaching the OPD, IPD and special camps to be conducted in Government Ayurvedic Medical College &Hospital Mysore and other referral will be selected for the study.

7.2)Method of collection of data:

  • Patients of either sex will be selected randomly on the basis of investigations, sign and symptoms of diabetic peripheral neuropathy.
  • Patients will be assigned in a single group consisting of 30 patients.

Diagnostic criteria:

  1. History of Diabetes with any of the following signs and symptoms.
  2. KarapadaDaha(Burning pain) in Hands & legs.
  3. Cumcumayana(Tingling sensation) in Hands & legs.
  4. Dourbalya (Muscle weakness)in Hands & legs.
  5. Suptataa(Sensory loss) in Hands & legs.
  6. Physical examination:
  7. Muscle strength and Reflexes.
  8. Sensitivity for touch, light touch, temperature, vibration, position change and pain.

Inclusion criteria

  • Patients with either sex of age group between 30 to 70.
  • IDDM&NIDDM with peripheral neuropathy, both fresh & treated patients.

Exclusion criteria:

  • Patients with other metabolic and endocrine diseases.
  • Patients with autonomic, proximal and focal neuropathic state.
  • Patient suffering from infectious diseases.
  • Patients with wound/ulcer.
  • Patients with other complications like Diabetic Nephropathy, Diabetic Ketoacedosis and Diabetic Coma.
  • Patients with diabetic neuropathy in stage N0,N2b,N3.

Assessment criteria:

•Based on clinical grading of signs and symptoms.

–A common staging of Diabetic Neuropathy followed (Dyek’s staging of Diabetic Neuropathy11).

•N0:No Neuropathy

•N1a:Signs but no Symptoms of Neuropathy.

•N2a:Symptomatic mild Diabetic Neuropathy; sensory, motor

or autonomic symptoms, patient able to walk on heel.

•N2b:Severe symptomatic Diabetic Neuropathy (as in N2a),

but patients unable to walk on heel.

•N3:Disabling Diabetic Neuropathy.

•Assesment of clinical features done on 1st day, after 10th day and on30th day of treatment.

•Assesment of blood glucose both FBS and PPBS done before and after the treatment.

•Data will be statistically analyzed by using following statistical methods

•Descriptive statistics.

•Cross tabulation

•Paired samples ‘t’ test

•Repeated measure ANOVA using SPSS for windows.

7.3)DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY.

YES

The study requires investigation and interventions to be conducted on patients of Diabetic Peripheral Neuropathy.

INVESTIGATIONS:

  • FBS
  • PPBS
  • Urine for

•Albumin

•Sugar

•Microscopy.

  • Other required investigations

•If nessessary.

INTERVENTION:

  • All 30 patients will be subjected toTakraDhara procedure for 1st 10 days of intervention for a duration of 45 minutes.
  • All30 patients are administered withPushyanugaChurna internally, 6gm BD, before food with Ushnodaka( as Anupana.)
  • Treatment done along with PathyaaharaVihara.
  • Duration of the treatment: 30 days.

7.4)HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?

YES

8. LIST OF REFERENCES:

1) a) Sushruta, SushrutaSamhita, Ayurveda-TattvaSandipika, Hindi commentary, KavirajAmbikadattaShastri, Part-I, Reprint 2011, Chowkamba Sanskrit Sansthana, Varanasi, NidanaSthana 6, pp 326-331.

b) Sushruta, SushrutaSamhita, Ayurveda-TattvaSandipika, Hindi commentary, KavirajAmbikadattaShastri, Part-I, Reprint 2011, Chowkamba Sanskrit Sansthana, Varanasi, CikitsaSthana 11, pp 74-78.

c)Caraka, CarakaSamhita, Vaidyamanorama Hindi commentary, AcaryaVidhyadharaShukla, Vol-1, First Edition 1998, ChowkhambaSanskrit Pratisthan, Delhi, NidanaSthana 4, pp 494-504.

d)Caraka, CarakaSamhita, VidydharaShukla, VaidyaManorama Hindi Commentary, Vol-2, First Edition 1998, Chaukhamba Sanskrit Pratisthan, Delhi, CikitsaSthana 6, pp 168-180.

e) Vagbhaṭa,AshtangaHrdaya, English commentary, Prof. K.R Srikanth Murthy, Vol-2, Reprint Edition 2008, ChowkhambaKrishnadas Academy, Varanasi, NidanaSthana 10, pp 92-99 & CikitsaSthana 12, pp 383-390.

2) a)Madhavakara, MadhavaNidana, Hindi Vyakhya, AcharyaNarendranathShastri, Reprint Edition 2005, MotilalBanarasidas Varanasi, Chapter 33, pp 472-496.

b) Sri Bhavamishra, Bhavaprakash, Vidyotini Hindi Commentory, Pandit Sri Brahma Shankar Mishra, Part-2, 8th Edition2003, Chaukhamba Sanskrit Bhavan, Varanasi, 386-409 pp

3) Caraka, CarakaSamhita, VidydharaShukla, VaidyaManorama Hindi Commentary, Vol-2, First Edition 1998, Chaukhamba Sanskrit Pratisthan, Delhi, CikitsaSthana 30, pp 767.

4) KastureHaridas, AyurvediyaPanchakarmiyaVijnana , Reprint Edition 2006, pp 93-96.

5)Namboothiri M. R., L. Mahadevan, M.D. and S. Gopakumar, Panchakarma problems and solutions and principles and practice of Dhara, SaradaMahadevIyer, Kanyakumari, pp 202-256.

6)J. Pavana and ManojShankaranarayana, KeraliyaCikitsaPaddhati – Sri Dharakalpah , 2008, Padmashri Dr. K RajagopalanAyurvedaGranthamalaSamithi, Thrissur, pp 16-27.

7)Harrison, Principles of Internal Medicine,Edited by Braunwald,Fauci,Kasper,Hauser,Longo,Jameson, Vol-2, 15th Edition, International Edition 2003, India, pp 2122-2123.

8) Davidson,Principles and Practice of Medicine,Edited by Christopher Haslett,EdwinR.chilvers,JohnA.A.Hunter,NicholasA.Boon, 18th Edition, Reprinted 2001, Churchill Livingstone, London, pp 501-502.

9) Robbin ,Robbin’s Basic Pathology, Edited by Kumar Abbas, Fausto and Mitchell, Published by Elsevier, U.P(India), pp775-787.

10) Guyton and Hall, Textbook of Medical Physiology, Published by W.B.Saunder company, Philadelphia,edition 9, pp980-982.

11)FA Gries, Cameron NE, Low PA, Ziegler D, Eds. Stuttgart, Thieme, Textbook of Diabetic Neuropathy, 2003, pp 170-175.

9. Signature of the Candidate:

10. Remarks of the Guide:

11. Names and Designation of:

11.1 Guide:DR. K. S. UMASHANKARM.D (AYU)

PROFESSOR,

DEPT OF P.G STUDIES IN KAYA CIKITSĀ

GOVERNMENT AYURVEDIC MEDICAL

COLLEGE,

MYSORE-570021

11.2 Signature and Seal:

11.3 Head of the Department:DR.GAJANANA HEGDEM.D(AYU)

PROFESSOR AND HOD

DEPTOF P.G STUDIES IN

KAYA CIKITSĀ,

GOVERNMENTAYURVEDAMEDICAL

COLLEGE,

MYSORE - 570021.

11.4 Signature and seal:

12. Remarks of the chairman andPrincipal:

12.1 Signature and seal:

1