Rajiv Gandhi University Of Health SciEnces KARNATAKA
BANGALORE
Completed prOforma for registration of subject
for dissertation
A COMPARATIVE PHARMACEUTICO-ANALYTICAL AND CLINICAL STUDY OF
RASNA SAPTAKA KASHAYAM AND RASNA SAPTAKA KASHAYAM TABLET
IN THE MANAGEMENT OF CERVICAL SPONDYLOSIS
by
dr.r vignesh devraj M.D (ayu) Scholar
Dept. Post Graduate Studies in Bhaishajya kalpana
S.D.M college of Ayurveda, Udupi
Guide
Dr.ravIndra angadi M.D (Ayu)
Assistant Professor
Dept. Of Post Graduate Studies in Bhaishajya kalpana,
S.D.M college Of Ayurveda, Udupi
co - Guide
Dr. ashok kumar B n M.D (Ayu)
Lecturer
Dept. Of Post Graduate Studies in Bhaishajya kalpana,
S.D.M college Of Ayurveda, Udupi
2009-2010
S.D.M College of Ayurveda
Kuthpady, Udupi
From,
DR. R Vignesh Devraj
MD Scholar
Dept. of Post Graduate Studies in Bhaishajya Kalpana
S.D.M College of Ayurveda
Kuthpady, Udupi-574118
To,
THE REGISTRAR,
Rajiv Gandhi University of Health Sciences,
Bangalore, Karnataka
Through,
The Principal and H.O.D of Bhaishajya Kalpana Dept
S.D.M College of Ayurveda
Kuthpady, Udupi-574118
Respected Sir,
Sub: Submission of completed Proforma for registration of subject of dissertation
I request you kindly register the below mentioned subject which has been reviewed and clarified, against my name for the submission of the dissertation to the Rajiv Gandhi university of Health Sciences, Bangalore, for the partial fulfillment of M.D (Ayu) in Bhaishajya Kalpana.
TITLE OF DISSERTATION
A COMPARATIVE PHARMACEUTICO-ANALYTICAL AND CLINICAL STUDY OF
RASNA SAPTAKA KASHAYAM AND RASNA SAPTAKA KASHAYAM TABLET
IN THE MANAGEMENT OF CERVICAL SPONDYLOSIS
Here with, I am enclosing the completed Proforma for the registration of Subject of dissertation.
Thanking you
Place: Udupi Your’s faithfully
Date:
DR.R Vignesh Devraj
1) Name of the candidate : DR. R VIGNESH DEVRAJ
M.D (AYU) SCHOLAR
DEPT. OF P.G STUDIES IN BHAISHAJYA KALPANA
S.D.M. COLLEGE OF AYURVEDA
2) Permanent Address : ‘JANANI NIVAS’,
CHELAT LANE,
SANKARA IYER ROAD
POOTHOLE P O
THRISSUR
KERALA (STATE) 680004
3) Name of Institution : S.D.M. COLLEGE OF AYURVEDA
KUTHPADY, LAXMINARAYANA NAGARA, UDUPI-574118
KARNATAKA
4) Course of study & Subject : M.D. (Ayu) IN BHAISHAJYA KALPANA
5) Date of admission of course : 16/06/2009
6) Title of the topic :
A COMPARATIVE PHARMACEUTICO-ANALYTICAL AND CLINICAL STUDY OF
RASNA SAPTAKA KASHAYAM AND RASNA SAPTAKA KASHAYAM TABLET
IN THE MANAGEMENT OF CERVICAL SPONDYLOSIS
6) Brief Resume of Intended Work:
6.1) Need for the study:
The Kashayam preparations are considered to be very effective and complete medicine, due to their viryatwa and laghuthwa. The palatability of the kashayam due to its astringent taste is quite often not approved by many patients; hence many pharmaceutical companies are making the kashayam in tablet forms by adopting the rasakriya1 method. The kashayam tablet form is fast gaining popularity due to its easy palatability, portability and prolonged shelf life.
Cervical spondylosis is a degenerative condition of the spine seen in the age group of above 40 yrs. Now with improper ergonomics and unhealthy life style even young people are suffering from it. Rasnasaptaka kashayam2,3,4,5 a yoga from Sharangadhara Samhita is an effective medicine widely indicated in painful conditions like greeva shula, jangha shula, uru shula, parswa shula, trika shula and prishta shula.
So rasnasaptaka kashayam is employed in the present study to evaluate its efficacy both in kashaya form and tablet form in the management of cervical spondylosis which is usually presenting with neck pain and stiffness.
6.2) Review of literature:
Literature pertaining to the present study will be reviewed from different Ayurvedic and modern text books: 1,2,3,4,5,7.
The preparation, ingredients and indication of Rasnasaptaka kashayam is available in
· Sharangadhara Samhita2
· Bhaishjaya Ratnavali3
· Sahasrayogam4,
· The Ayurvedic Formulary of India5.
The analytical study to be conducted is followed from the book - Quality control manual for Ayurvedic, Sidha and Unani medicine6.
6.3) Previous works done:
1. Patel Kalopi B. A clinical study on the development of subtype of abhyanga w.s.r to its role in the management of grivahundana (cervical spondylosis), Gujarat Ayurveda University, Jamnagar (2002)
2. Bhadaria A. Cervical Spondylosis Ayurvedic diagnosis and its management by panchakarma therapy w.s.r to abhyanga, swedana and nasya karma. National Institute of Ayurveda Rajasthan, Jaipur (1996)
6.4) Objective of the study:-
1. To do comprehensive review of kashaya kalpana, rasnasaptaka kashayam and cervical spondylosis.
2. Preparation of Rasnasaptaka kashayam as explained in sahasrayogam2
3. Preparation of Rasnasaptaka Kashayam tablet by adopting the rasakriya method explained in Sarangadhara Samhita1.
4. To assess the physico-chemical property of samples of Rasnasaptaka kashayam and Rasna saptaka kashayam tablet.
5. Clinical study on the therapeutic effect of rasnasaptaka kashayam and rasnasaptaka kashayam tablet in cervical spondylosis.
7) Materials & Methods
7.1 Source of Data:
Analytical study
[A] Literary source: Literary source is Ayurvedic classical textbooks. Information will be collected from modern text and relevant research literature.
[B] Pharmaceutical source:
1) Raw drug for the preparation of rasnasaptaka kashayam and rasnasaptaka kashayam tablet will be collected from S D M Ayurveda Pharmacy, UDUPI
2) Preparation of Rasnasaptaka kashayam and rasnasaptaka kashayam tablet will be carried out in S D M Ayurveda Pharmacy, UDUPI
[C] Analytical source:
Analytical study will be carried out in S.D.M. Ayurvedic Pharmacy Lab Udupi.
1. Organoleptic characters.
2. Physico-chemical constants.
3. Pharmaceutical standardization of tablet.
4. Chromatography
5. Particle size assessment
7.2) Method of Data Collection
1. Pharmaceutical study
· Rasnasaptaka Kashayam will be prepared as per Sharangadhara Samhita2 reference.
· Rasnasaptaka Kashayam tablet will be prepared adopting the rasakriya method as explained in sharangadhara Samhita.1
2. Analytical study
A) Organoleptic analysis
a) Colour
b) Taste
c) Odour
d) Appearance
B) Physico-Chemical Analysis
a) Ph
b) Total Ash value
c) Acid insoluble Ash
d) Water soluble Ash
e) Loss on drying
3. Pharmaceutical standardization of table
a) Uniformity in size
b) Uniformity in weight
c) Uniformity in the chemical composition
d) Hardness of tablet
e) Friability
f) Disintegration time
g) Dissolution time
4 Chromatography
TLC/any other if required
5 Clinical study
It is a single blind clinical study with a minimum of 20 patients suffering with cervical spondylosis, taken from O P D & I P D of S D M Ayurvedic Hospital Udupi.
Inclusion criteria;
· Patient diagnosed as cervical spondylosis.
· Age group between 16 to 70 yrs.
Exclusion criteria
· Age group below 16 and above 70 yrs.
· Congenital deformities of spine
· Spine tuberculosis
· Patient suffering from systemic disorders which may manipulate the course of treatment.
· Traumatic and neo-plastic conditions of spine
Assessment criteria
a) Subjective parameters
· Neck pain (usually worse on arising in the morning), pain in back of head, shoulder blades or down the arms
· Neck stiffness, painful and difficult movement of neck
· Arm weakness and clumsiness
b) Objective parameters
· Tenderness, movements of the neck, power and reflex
7.4) Does the study require any investigation or any intervention to be conducted
on Patient or other humans or animals:
· The study will only be a human clinical study and no animal experiments will be conducted.
Investigations;
Plain X – rays (including lateral and oblique views)
Intervention;
· Kashaya: Dwipala (96 ml) of kashayam per day in divided doses for a period of 30 days.
· Kashayam tablet: Four tablets (each tablet of 1000mg) thrice daily with ushna jala as anupana for a period of 30 days
· Follow up period – 15 days
7.5) Has ethical clearance been obtained from your institution?
Yes-
8.0) List of Reference:
1) Sharangadhara. Sharangadhara Samhita with the commentaries of Adhamalla’s Deepika and Kashiram’s Gudartha deepika, edited by Parashurama shastry vidyasagar, 1st edition. Varanasi: Chaukambha Surabharati Prakashan; 2006. Pp.398, p. 206.
2) Sharangadhara. Sharangadhara Samhita with the commentaries of Adhamalla’s Deepika and Kashiram’s Gudartha deepika, edited by Parashurama shastry vidyasagar, 1st edition. Varanasi: Chaukambha Surabharati Prakashan; 2006. Pp.398, p. 155.
3) Govindadasa. Bhhaisajyaratnavali with vidyothini hindi commentary by Sri Kaviraja Ambikadatta Shastri ayurveda acharya edited by Rajeshwara data sastri, 16th edition. Varanasi: Chaukambha Samskrita Samsthana; 2002. Pp.861, p.436.
4) Vaidya K V Krishnan, B Gopala Pillai. Sahasrayogam with Sujana Priya Vyakhyana,
27th edition. Allapuzha: Vidyarambham Publishers; 2004. Pp.544, p.84.
5) The Ayurvedic Formulary of India-2, on behalf of Government of India Ministry of health &
Family welfare, Department of Indian Systems of medicine and homeopathy, 1st edition. New Delhi: Controller of Publications Civil Lines; 2000. Pp.425, p.82.
6) Dr.Lohar, Ravindra Singh. Quality control manual for ayurvedic, sidha and unani medicine, 1st edition. Ghazhiabad: Department of Ayush, ministry of health and family welfare, Pharmacopeial laboratory for indian medicine; 2008. Pp.71, p.11.
7) Davidson. Principles & practise of Medicine. 20th edition. PA, United States of America: Churchill Livingstone Elsevier Limited; 2006. Pp. 1381, P. 1241.
9.0) Signature of the candidate :
10.0) Remarks of the guide :
11.0) Name and Designation
11.1) Guide : DR. RAVINDRA ANGADI M.D. (AYU)
ASSISTANT PROFESSOR
DEPT. OF PG STUDIES IN
BHAISHAJYA KAPLANA.
S.D.M.C.A., UDUPI.
11.2) Signature :
11.3) Co-Guide : Dr. ashok kumar B .n M.D (Ayu)
LECTURER
DEPT. OF PG STUDIES IN
BHAISHAJYA KAPLANA.
S.D.M.C.A., UDUPI.
11.4) Signature :
11.5) Head of the Department : DR.SEKHAR REDDY.P M.D (AYU)
ASSISTANT PROFESSOR & H.O.D
DEPT. OF PG STUDIES,
BHAISHAJYA KAPLANA
S.D.M.C.A., UDUPI.
11.5) Signature :
12.0) Remarks of the Chairman and the Principal :
12.1) Signature :
1