RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION IN M.D (AYURVEDA)
A PHARMACEUTICO-ANALYTICAL AND CLINICAL STUDY OF RASANJANADI YOGA
W.S.R TO MUKHAPAKA AND ITS PHARMACEUTICAL MODIFICATION
By
DR.NIMISHA.S
1ST YEAR M.D (AYU) SCHOLAR
DEPT. OF P.G. STUDIES IN RASASHASTRA
ALVA’S AYURVEDA MEDICAL COLLEGE
MOODBIDRI, D .K,
KARNATAKA-574227
GUIDE
DR.B.VINAYACHANDRA SHETTY, M.D (AYU)
ASST. PROFESSOR
DEPT. OF RASASHASTRA
ALVA’S AYURVEDA MEDICAL COLLEGE,
MOODBIDRI, D.K
KARNATAKA-574227
2010-2011
ALVA’S AYURVEDA MEDICAL COLLLEGE
MOODBIDRI, D.K DISTRICT,KARNATAKA -574227
From,
Dr.Nimisha.S
Ist yr M.D (AYU) Scholar
Dept.of Rasa Shastra
Alvas Ayurveda Medical College
Moodbiri, Karnataka
To,
THE REGISTRAR (EVALUATION)
Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka.
Through
The Principal,
Alvas Ayurveda Medical College
Moodbidri, Karnataka
Respected Sir,
Sub: Submission of completed Proforma for registration
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 the partial fulfillment of M.D (Ayurveda).
TITLE OF THE DISSERTATION:
“A PHARMACEUTICO-ANALYTICAL AND CLINICAL STUDY OF RASANJANADI YOGA W.S.R TO MUKHAPAKA AND ITS PHARMACEUTICAL MODIFICATION”
Thanking you Sir,
Place : MOODBIDRI Yours Faithfully
Date : 20/04/2011 Dr. NIMISHA.S
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the candidate & Address / Dr.Nimisha.S1st yr M.D(AYU)Scholar
Dept.of Rasa shastra
Alvas Ayurveda Medical College
Moodbidri, Karnataka – 574 227
D/O SATHEESAN.V
Nandanam,Perumpanachy(P.O)
Changanacherry, Kottayam
Kerala – 686 536
2. / Name of the Institution / Alva’s Ayurveda Medical College,
Vidyagiri, Moodbidri
Mangalore, Karnataka – 574 227
3. / Course of study and subject / 1st YEAR MD(AYU) RASASHASTRA
4. / Date of admission to Course / 01-11-2010
5. / Title of the Topic / “A PHARMACEUTICO- ANALYTICAL AND CLINICAL STUDY OF RASANJANADI YOGA W.S.R TO MUKHAPAKA AND ITS PHARMACEUTICAL MODIFICATION"
6) BRIEF RESUME OF THE INTENDED WORK
6:1) NEED FOR THE STUDY
In present era, world is looking at Ayurveda with the hope that it is going to provide good asset to the treatment of ailing humanity.
Sarvasara Mukha Rogas are named as Mukhapaka as it occurs by spreading completely in mukha. Rasanjanadi Yoga is in churna form and it contains the ingredients like Rasanjana, Lodhra, Gairika, Manashila, Gajapippali, Nagara, Pata, Haridra and Shunti which is used externally. In Rasanjanadi Yoga, Rasanjana is the main ingredient which has got proven results in Mukha Rogas.
Mukhapaka is compared with Stomatitis which occur due to various causes like simple cut to the mouth, eating very hot food items, improper cleaning of teeth, vitamins deficiencies, general weakness etc and the presenting complaints are inflammation of oral mucosa, ulceration in the mouth, altered taste, pain, burning sensation and itching sensation in the mouth, difficulty in mastication and discomfort.
As herbo-mineral drugs are used in the preparation of the yoga, the analytical study of the prepared yoga and modified yoga is necessary. Herbo-mineral compound formulations are more potent, easily absorbed and assimilated in the body.
In the classics, the yoga is mentioned in churna form but in the present busy life it will be difficult for the patients to apply .So it is a need to modify the yoga for the better and easy use.
The research work will be complete only if it is clinically studied and so far no study has been carried out in Rasanjanadi Yoga. Hence the study will be undertaken.
6:2) REVIEW OF LITERATURE
Ø The details of Preparation of the Rasanjanadi Yoga will be reviewed from the text Chakradatta in Mukha Rogadhikara
Ø Pharmaceutical modification into ointment will be reviewed from Theory and practice of Industrial pharmacy texts, journals and internet
Ø Description regarding Mukhapaka from Ayurvedic texts and journals
PREVIOUS WORK DONE
Ø Watker JP – Mukhapaka vyadhi par Rasanjana aushadi ka nirmana evam aturalyan adhyayana, Shalakya tantra, Ayurveda Mahavidhyalaya,Nagpur-1997
6:3) AIMS AND OBJECTIVES OF THE STUDY
Ø Preparation of Rasanjanadi Yoga according to the classics
Ø Analytical study of Rasanjanadi Yoga
Ø Pharmaceutical modification of Rasanjanadi Yoga
Ø Analytical study of prepared Rasanjanadi Yoga
Ø Clinical study of Rasanjanadi Yoga
7) MATERIALS AND METHODS
7:1) Source of study
Literary study
All the relevant classical texts, modern texts and also from recent Medical journals and internet
Pharmaceutical study
Drugs for the preparation will be collected from genuine source.
Necessary processing of raw materials and preparation of yoga will be done in Rasashastra and Bhaishajya kalpana P.G Lab, ALVA’S Ayurveda Medical College
Analytical study
Physico-chemical analysis of the prepared yoga and modified yoga will be done in accredited laboratory
Clinical study
Patients of either sex suffering from Mukhapaka fulfilling the diagnostic criteria will be selected for the study, attending the OPD of ALVA’S Ayurveda Medical College, Hospital, Moodbidri, Medical Camps and other referrals
7:2) METHOD OF COLLECTION OF DATA
a) Pharmaceutical study
v Rasanjanadi Yoga
Ø Rasanjanadi Yoga contains the following ingredients Rasanjana, Lodhra, Kushta,Pata ,Haridra,Gajapippali,Nagara, Manashila and Gairika
Ø Rasanjana will be prepared by mixing Daruharidra kwatha with equal quantity of goat’s milk and will be heated until it gets solidifies6.
Ø Shodhana of Manashila will be done by giving Bhavana with Ardraka swarasa for seven times7
Ø Shodhana of Gairika will be done by giving Bhavana with Milk8.
Ø All the ingredients will be finely powdered and mixed together
v Modified Rasanjanadi Yoga
Ø The prepared Rasanjanadi Yoga will be converted into ointment form according to modern techniques
b) Analytical study
Analytical evaluation of prepared yoga and modified yoga will be done
Physical : Organoleptic characters
Ash value
Acid insolubility ash
Loss on drying
Loss on ignition
Chemical : N.P.S.T
c) Clinical Study Design
i) Sample size
Ø 40 patients fulfilling the inclusion criteria of Mukhapaka will be selected and assigned into two groups
Group A - 20 patients will be managed with placebo
Group B - 20 patients will be managed with Rasanjanadi Yoga
ii) Observational period
Ø Placebo will be given for Group A
Ø Modified Rasanjanadi Yoga will be given for application on the affected area thrice daily for 5 days after food for Group B
Ø Follow up will be done on 5th day, 10th and 15th day of the treatment.
iii)Diagnostic criteria
Ø The clinical features of all the types of Mukhapaka mentioned in Sushrutha Samhitha will be taken as basis for the diagnosis
Ø Patients with two or more symptoms of Mukhapaka will be selected for the study like Painful blisters in mouth, Burning sensation, Redness , Itching sensation, Reddish yellow colour patches
iv) Inclusion criteria
Ø Patients fulfilling the diagnostic criteria of Mukhapaka will be randomly selected irrespective of sex, religion, occupation, socio-economic status
Ø Patients between the age group of 16-60years will be selected for the study
v) Exclusion criteria
Ø Pregnant and lactating women
Ø Patients below the age group of 16 and above 60 years
Ø Patients suffering from any systemic illness which interfere the duration of course of treatment
Ø Non healing ulcers of malignancy, syphilis etc
vi) Assessment criteria
Ø The general condition of the patients before treatment will be noted by thorough screening of lakshanas, detailed history and physical examination, later the changes in the lakshanas after treatment will be noted
Ø Effect of treatment will be assessed statistically also on the basis of both subjective and objective parameters before and after the treatment
Subjective parameters
Ø Pain
Ø Burning sensation
Ø itching
Objective parameters
Ø Number of ulcers
Ø Size
Ø Shape
Ø colour
7:3) Does the study requires any Investigation or intervention to be conducted on patients or other humans or animals if so, please describe briefly.
This study will be conducted clinically. No animal experimentation will be carried out
7:4) Has ethical clearance has been obtained from your institution in case of 7:3?
Yes clearance has been obtained through the ethical committee formulated in the institution.
LABORATORY INVESTIGATIONS
Ø Liver Function Test
Ø Urine Routine
8) List of References
1) Sri Vagbhatacharya,Rasa Ratna Samuchaya,Translated by Dr.Indra Dev Tripati, Edited by Dr.Kapidev Giri,Varanasi,Chaukambha Sanskrit Sansthan Publication,2009,3rd chapter, 103 verse,36pp
2) Shri Chakrapanidatta, Chakradatta Translated by Dr.Indra Dev Tripati, Edited by Prof.Ramnath Dwivedy, Varanasi,Chaukambha Sanskrit Sansthan Publication,2002,46th chapter, 31 verse,333 – 334pp
3) Sir Leonlachman Herbert A Lieberman,Joseph .l.Kanig,The Theory And Practice of Industrial Pharmacy,Bombay, Varghese Publication House, Hind Rajasthan Building,18th chapter,534pp
4) MaharshiSushrutha,SusruthaSamhitha,translatedby,Dr.P.V.Sharma,volII, Varanasi,Chaukambha Vishvabharathi publication,2005,64-66 verse,114 pp
5) Maharshi Charaka,Charaka Samhiha,translated by Dr.Priyavat Sharma,vol II,Varanasi,Chaukambha Orientaia,2007,19-198 verse,446pp
6) Maharshi Vagbhata,Ashtanga Hridayam,Translated by Achuthavarrier,13th reprint 2009,Published by Devi book house,kerala,pg:184,verse 13-15
7) Shri Madhavacharya, Ayurveda Prakasha, Edited by Shri GulrajSharma Mishra,Varanasi, Chaukambha Bharati Academy publication, 1999, 2ndChapter,234 verse,316pp
8) Sri Vagbhatacharya,Rasa Ratna Samuchaya,Translated by Dr.Indra Dev Tripati, Edited by Dr.Kapidev Giri,Varanasi,Chaukambha Sanskrit Sansthan,2009,3rd chapter, 96 verse,35pp
9) Sri Vagbhatacharya,Rasa Ratna Samuchaya,Translated by Dr.Indra Dev Tripati, Edited by Dr.Kapidev Giri,Varanasi,Chaukambha Sanskrit Sansthan,2009,3rd chapter, 40verse,35pp
9. Signature of candidate :
10. Remarks of the guide :
11. Name and designation of
11.1 Guide : DR.B.VINAYACHANDRASHETTY,M.D (AYU)
ASSISTANT PROFESSOR
DEPT. OF P.G STUDIES IN RASASHASTRA
ALVA’S AYURVEDA MEDICAL COLLEGE,
MOODBIDRI, DAKSHINA KANNADA-574227.
11.2 Signature and seal of the Guide :
11.3 Head of the department : DR.B.VINAYACHANDRA SHETTY, M.D (AYU)
ASSISTANT PROFESSOR
DEPT. OF P.G STUDIES IN RASASHASTRA
ALVA’S AYURVEDA MEDICAL COLLEGE,
MOODBIDRI, DAKSHINA KANNADA-574227.
11.4 Signature & Seal :
12. Remarks of Principal :
12.1 Signature & Seal :