20RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCESKARNATAKA
BANGALORE
COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT
FOR DISSERTATION
“A CLINICO-PHARMACOLOGICAL STUDY TO EVALUATE
THE EFFICACY OF PRASARINI TAILANASYA KARMA
IN CERVICAL SPONDYLOSIS”
BY
Dr.CHANDUMETRI
M.D (AYU) SCHOLAR
DEPT OF P.G STUDIES IN PANCHAKARMA
S.D.M.COLLEGE OF AYURVEDA
KUTHPADY, UDUPI – 574118
GUIDE
Dr. NIRANJAN RAO. MD (Ayu)
PROFESSOR
DEPT. OF PG STUDIES INPANCHAKARMA
S.D.M.COLLEGE OF AYURVEDA
KUTHPADY, UDUPI-574118
CO-GUIDE: CO-GUIDE:
Dr.SHREEKANTH.U.MD (Ayu) DR.B.RAVISHANKAR.PhD(pharmacology)
HOD AND PROFESSOR DIRECTOR
DEPT. OF PG STUDIES IN S.D.M CENTRE FOR RESEARCH IN
PANCHAKARMA AYURVEDA AND ALLIED SCIENCE
S.D.M.COLLEGE OF AYURVED S.D.M.COLLEGE OFAYURVEDA
KUTHPADY, UDUPI – 574118 KUTHPADY, UDUPI- 574118
S.D.M. COLLEGE OF AYURVEDA
KUTHPADY, UDUPI – 574 118
2012 -2013
From,
Dr.CHANDU METRI M.D(Ayu) Scholar
Dept. of P.G. Studies in Panchakarma,
S.D.M. College of Ayurveda,
Kuthpady, Udupi-574118.
To,
The Registrar
Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka.
Through,
The Principal
S.D.M. College of Ayurveda,
Kuthpady, Udupi-574118
Respected Sir,
Sub: Submission of completed proforma for registration of subject fordissertation.
I request you to kindly register the below mentioned subject against my name for submission of dissertation to Rajiv Gandhi University of Health Sciences, Bangalore for partial fulfillment of M.D.(Ayu) in Panchakarma.
TITLE OF DISSERTATION:
“A CLINICO - PHARMACOLOGICAL STUDY TO EVALUATE
THE EFFICACY OF PRASARINI TAILANASYA KARMA
IN CERVICAL SPONDYLOSIS”
Here with I am enclosing completed proforma for registration of subject for dissertation.
Thanking you,
Yours faithfully,
Place: Udupi
Date: 20/04/2013 ( Dr.CHANDU METRI)
1. Name of the candidate:Dr.CHANDU METRI,
& Address 1st YEAR M.D.
(In block letters) DEPT. OF P.G. STUDIES IN
pANCHAKARMA,
S.D.M. COLLEGE OF AYURVEDA,
KUTHPADY, UDUPI, 574118.
Permanent Address: S/O ANAND METRI
AT.MUTNAL,
POST.NANDAGAON,
TQ.GOKAK,
DIST.BELGAUM,
KARNATAKA- 591231
2. Name of the Institution : S.D.M. College of Ayurveda,KUTHPADY,
UDUPI- 574118
3. Course of study and subject: M .D(Ayu) PANCHAKARMA
4. Date of admission to course: 24 DEC 2012
5. Title of the Dissertation:
“A CLINICO -PHARMACOLOGICAL STUDY TO EVALUATE
THE EFFICACY OF PRASARINI TAILANASYA KARMA
IN CERVICAL SPONDYLOSIS”
6. Brief resume of the intended study:
6.1 Need for the study:
“UrdhwaJatruVikareshuVisheshaat Nasyamishyate”1
Nasya karma is considered as a prime line of treatment in urdhwajatruvikaras. Cervical Spondylosis and its related conditions can also beconsidered as Urdhwajatrugatavikaras.
cervicalspondylosis is a degenerative condition of the cervicalspinein the general population with incidence rate of 83 per 100000 populations and prevalence of 3.3 cases per 1000 people and occurs mostly in fourth and fifth decades of life. The etiology of cervical spondylosis is associated with the ageing process of life2. In a report on radiographic evidence prevalence in male was 13% in 3rd decade and increases to 100% by the age of 70years.But in female it ranges from 5% in 4th decade to 96% by the age of 70years (Irvine et al)3.With change in lifestyle, increased desk work and increased usage of computer incidence of cervical spondylosis is increasing.
Vishwachi, apabahuka,manyasthambha disorders comes under Urdhwajatrugatavikaraswith their signs and symptoms4,5which are having certain commonality incervical spondylosis as explained in allied science.Prasarini tailanasya karma mentioned in classical texts is useful in such disorders10. With this view in background this study is proposed to assess the effect of Prasarinitaila nasya karma in cervical spodylosis clinically.
Ayurveda explained nasya karma is prime line of treatment in urdhwajatruvikaras.To identify the changes in nasal mucosa or nervous system an experimental study is designed, concerned about nasya karma.
6.2Review of Literature:
- Nasya karma being one of the panchakarma which is good for urdhwajatrugatavikara has been mentioned in CarakaSamhita, Siddhisthana6.
- The signs and symptoms of CervicalSpondylosis such as neck pain, weakness in handshas been explained in Harrisons Principles of Internal medicine7, Davidsons’s principles of internal medicine8 and Golwalla medicine for students9.
- PrasariniTaila is mentioned in Bhavaprakash for Nasya Karma for Apabhahuka,Vishwachi,Manyasthambha etc10.
Previous works done on the subject:
- “Clinical study on the effect of Mahamashatailanasya karma in Ardita”, showed good improvement in 10% of patients, average improvement in 60% of patients and mild improvement in 30% of patients.The result of the study was such that the brahmana effect of Nasya karma is seen in the form of marginal effect11.
- “Clinical study on the effect of snehana and nasya karma onAsthimajjagatavata with special reference to cervical spondylosis12.
- A clinical study to evaluate the effect of Nasya Karma by Ketakyaditaila in Cervical Spodylosis. This study proved the ketakyaditailanasya karma helps to pacify the vataprakopa due to its snehana and bhrimhanaqualities,and increases the functional ability. The result shows significant remission in signs and symptoms of illness cervical spondylosis13.
6.3Objectives of the study:
- To evaluate the efficacy of PrasariniTailanasya karma in Cervical spondylosis.
- To evaluate the influence of PrasariniTailanasya karma by certain anatomical,
physiological and biochemical changes through animal experimentation.
7. Materials and methods:
7.1 Source of data: Minimum of 20 patients, suffering from cervical spondylosis coming under the inclusion criteria approaching the OPD and IPD of SDM Ayurveda Hospital, Udupi, will be selected for the study.
7.2 Methods of collection of data:
Minimum 20 patients of either sex will be included in clinical study. Patients will be selected on the basis of clinical examination;detailedproforma will be prepared by incorporating all the signs and symptoms of cervical spondylosis.
Diagnostic criteria of Cervical spondylosis14:
Neck pain
Weakness in neck region
Pain in medial scapular region and shoulders.
Head ache.
Clumsy finger movements
Tenderness in cervical region
Rigidity of neck
Sensory loss in upper limbs.
Giddiness.
Inclusion criteria:
- Patients of either sex age between 20 to 70 yrs will be taken.
- Patients presenting with the signs and symptoms of cervical spondylosis.
- Patients who are fit for nasya karma.
Exclusion criteria:
1.Patients with traumatic injury of cervical spine.
2.Patients with major systemic disorders that may interfere with the course of treatment.
3. Patients suffering from neoplastic disorders.
Study Design:
This is a open clinical study with pre test and post test design where in minimum of 20
Patients diagnosed as cervical spondylosisof either sex will be selected. All patients fulfilling the inclusion criteria will be subjected to PrasariniTailanasya karma.
Plan of the treatment:
PoorvaKarma - Mukhabhyanga withPrasariniTaila and Swedana with hot water.
PradhanaKarma – NasyaKarma using PrasariniTaila.
Dose – 8 drops to each nostril.
PaschatKarma – Dhoomapana with haridrachoorna.
Total duration:7 consecutive days.
Follow up study:7 days after completion of course of theNasya karma.
Assessment criteria:
Subjective parameters:
Samyaklakshanas of nasya karma
Neck pain
Stiffness
Weakness
Clumsy finger movements
Vertigo.
Radiating pain to occipito frontal region, shoulder down to both arms.
Paraesthesia.
Objective parameters15:
Tenderness over cervical region
Movements of neck painful/restricted
Neurologic deficit.
Power of hand muscles
Reflexes of hand ligaments
Laboratory Investigations:
X- Ray cervical spine AP and Lateral.
Bloodroutine investigation.
CR Protein.
RA Factor.
CT, MRI if necessary.
7.2) Method of collection of data (including procedures if any)
Experimental evaluation:
1 / Sample / 12 Wistar albino rats of either sex will be selected randomly.2 / Inclusion Criteria / 1) Healthy albino rats of either sex will be considered.
2) Weighing about 150-200g.
3 / Exclusion Criteria / 1) Less than 150g – more than 200g.
2) Pregnant and diseased rats.
3) Rats which are under trial of other experiments.
4 / Grouping / Each group having 6 rats and will be kept in separate cages.
Group (1)- Control Group-6 rats
Group (2)- Trial Group-6 rats
5 / Method / After local snehana and swedana the test oil would be administered drop by drop with the help of small cannula sleeved on to a 1 ml syringe. The dose for rat would be calculated on the basis conversion of human dose to rat dose. This amount would be administered drop by drop with the help of cannula by placing the rat on supine position. This procedure would be continued for seven consecutive days. The general behavioral changes would be recorded daily. On the seventh day one hour after nasya karma the rats would be assessed for different activities like- effect on muscle tone and balance, spontaneous motor activity, spatial memory, anti-anxiety and anti-depressant. At the end of the experiment blood would be collected to assess the impact of nasyakarma on selected biochemical and hematological parameters. Rats would be sacrificed nasal cavity structures and brain parts just above the nasal cavity (olfactory lobe and frontal lobe of the cerebrum) would be subjected to histological examination.
6 / Materials used / 1. Rotarod instrument. 4. Polyproyle jars.
2. Observation chamber. 5. Morris Maze.
3. Activity cage instrument.
7 / Assessment Criteria / As per standard procedure.
8 / Duration / As required for each test.
9 / Comparison / Both Groups are compared.
10 / Statistical analysis / Students, Unpaired‘t’ test.
11 / Intervention / Rat dose will be calculated on the basis of human dose by using standard conversion method.
12 / Method of administration / Nasal route.
7.3 Does this study requires any investigations or intervention to be conducted on patients or other humans or animals?
Yes, the study will be conducted on human subjects who match the inclusion criteria and animal experimentation.
Influence of PrasariniTailanasya on Anatomical and physiological changes parametersin experimental animal.
7.4 Hasthe ethical clearance is obtained from your institution in
caseof 7.3?
Yes, ethical clearance is obtained through the ethical committee formulated in this institution.
8. List of references:
1. Vagbhata, AstangaHrudaya , commentaries of Sarvangasundara of Arunadatta and
Ayurvedrasayan of Hemadri, edited by ParadakaraHariSadashivShastri, Varanasi, ChaukambaSurbhartiPrakashan,Print2007, Pp: 956: Page no.287
2. Borin.G .scherad.Hsand.T Neck pain in general population-spine 1994;19;13079. {International journal of health sciencereaserches.} 3. 564.htm.
4.Bhavamishra, Bhavaprakasha edited with the Vidyodinihindi commentary, part 2, eleventh edition, Chaukamba Sanskrit Bhavan, 2007, Varanasi. Pp:836, Pg no:268.
5. Susrutha, Susrutha Samhitha with Nibandha sangraha commentary and the
NyayachandrikaPanjika of Sri.Gayadasacharya on Nidanasthana, edited by VaidyaJadavjiTrikamjiAcharya, ChaukambaSurbharatiPrakashan, Reprint 2008, Pp:824, Pg no:268.
6. Agnivesha, CharakaSamhitha elaborated by Charaka and Drdhabala with TheAyurvedaDeepika commentary by Cakrapanidatta on Siddhisthana edited byVaidyaJadavjiTrikamjiAcharya, ChaukambaSurbharathi, Prakashan, Varanasi, Reprint 2008. Pp:738, Pg no:722.
7. Fauci AS, BraunwaldE,Kasper DL, Hauser SL, Longo DL, Jameson JL, Loscalzo, edited Harrisons’s Principles of Internal Medicine, Volume 1, 17th edition, Mc Graw-Hill, Medical Publishing division, Pp no:1364, Pg no:116.
8. Nicholas A.Boon edited Davidson’s Principles of Internal medicine, 20th edition,
reprinted 2006, Publisher’s Library of Congress, cataloging in publication data, Pp no:1326, Pg no:1241.
9. Aspi F. Golwalla and Sharukh A. Golwalla, edited Golwalla Medicine for students 21st edition 2005; Published by ASPI Golwalla; Pp:1212, Pg no:587.
10. Bhavaprakash, SheemadbhishagbhooshanaBhavamishrapranitah,’vidyotini’-NamakayabhashaTikayasamvatitah.Edited with Vidhyotinihindhi commentary by BhishagratnaPandit Sri BhrahmaSankar Mishra.Part-2,chaukambha Sanskrit bhavan,Varanasi.11th edition 2010.Chikitsasthan chapter no.24,pp:836,pg.no.230-231.
11. Kumar Vinay.K.N. A Clinical study of Nasya Karma in Cervical Spondylosisa dissertation submitted to the RGUHS, Bangalore in partial fulfillment of the requirements for the degree of AyurvedaVachaspathi, Doctor of Medicine (Ayu) inPanchakarma. 2009-2010.Pp:103, Pg no:88,89.
12. Shaligram, Asthimajjavata with special reference to cervical spondylosis , and role of snehana and nasya karma in it’s management. Gujarat AyurvedaUniversity , Jamnagar 1998.
13. Dr.Vignesh H.-A clinical study to evaluvate the effect of Nasya Karma by Ketakyadi taila in Cervical Spodylosis.RGUHS Karnataka , sdmca kuthpady udupi .2011-2012,
Pp:191,pg.no.153.
14. Nicholas A.Boon edited Davidson’s Principles of Internal medicine , 20th edition, reprinted 2006, Publisher’s Library of Congress, cataloging in publication data, Pp no:1326, Pg no:1241.
15. David.J.Magee edited Orthopedic Physical Assessment 5th edition 2008, published by Elservier. Pp no:1138, Pg no:130-202.
9. SIGNATURE OF THE CANDIDATE:
( Dr. CHANDU METRI )
10. REMARKS OF GUIDE:
11. NAMES AND DESIGNATIONOF -
11.1. GUIDE : DR. NIRANJAN RAO M.D (Ayu)
PROFESSOR,
DEPT. OF P.G STUDIES IN PANCHAKARMA,
S.D.M.COLLEGE OF AYURVEDA,
KUTHPADY UDUPI – 574118
11.2.SIGNATURE :
11.3. CO-GUIDE : Dr. SHREEKANTH U M.D(Ayu)
PROFESSOR HOD
DEPT. OF P.G STUDIES IN PANCHAKARMA
S.D.M.COLLEGE OF AYURVEDA,
KUTHPADY UDUPI - 574118
11.4. SIGNATURE :
11.5. CO-GUIDE : DR.B.RAVISHANKAR.PhD(pharmacology)
DIRECTOR
S.D.M CENTRE FOR RESEARCH IN
AYURVEDA AND IN ALLIED SCIENCE
S.D.M.COLLEGE OF AYURVEDA
KUTHPADY, UDUPI- 574118
11.6.SIGNATURE :
11.7. H.O.D: DR.SHREEKANTH U. M.D(Ayu) PROFESSOR AND H.O.D.
DEPT. OF P.G STUDIES IN PANCHAKARMA,
S.D.M.COLLEGE OF AYURVEDA,
KUTHPADY UDUPI - 574118
11.8. SIGNATURE :
12. REMARK OF THE
CHAIRMAN & PRINCIPAL:
12.1 SIGNATURE:
1