[ A ] VI. BRIEF RESUME OF THE INTENTED WORK
6.1.Need for the study:
The body matrix life in Ayurveda is conceived as the union of body, senses, mind and soul. The aim of Ayurveda is to integrate and balance the body, mind and spirit which are believed to help prevent illness and promote wellness. All physical symptoms of diseases result from imbalance of doshas, dhathus and agni. The main cause of the imbalance are due to the fast lifestyles, irregular food habits, stressful life, smoking and alcoholism.
Being regulator of all other dosha,the disease caused by vata dosha is much importance. Pakshaghatha remains in prime position among all other vata vyadhis. It is one among vataja nanathmaja vyadhis. Pakshaghatha is a severe blow to the sufferer’s life. The patient not only suffers a bodily illness but also go through a severe mental depression on account for inability to attend such duties as are essential for personal hygiene and maintenance of his own cleanliness.
The description of Pakshaghatha can be interpreted with Hemiplegia. The commonest cause of Hemiplegia is Cerebrovascular Accident or stroke. The term stroke defines rapidly developing clinical symptoms and signs of focal and at times global, loss of cerebral function lasting more than 24hrs, or leading to death, with no apparent cause other than of vascular origin. The ischemic stroke refers to a vascular insufficiency (thromboembolism) rather than hemorrhage.
Stroke is the third most common cause of death in developed nations, where nearly 4.5million persons die from stroke each year. The world wide incidence has been quoted as 2/1000 population per annum, about 4/1000 in people aged 45-85 yrs. Stroke represented 1.2%of total deaths in India. About 5.71million people died from stroke in 2004, and estimated that the number will climb to 6.3million in 2015 and 7.8million in 2030.
Risk factors for stroke are family history, hypertension, diabetes, cardiac disease particularly valvular disease, transient ischemic attack, serum cholesterol level etc. Causes are 1.Ischaemic- a)Cerebralinfarction, b)Cerebralischaemia, 2.Haemorragic -a) Hypertension, b) Trauma, 3.Undetermined origin. With advent of modern drugs, the pattern of disease has grossly changed, where the drugs only assuage the symptoms temporally and the underlying pathology goes on progressively to worsen the condition. Though ample research is being carried out for alleviating the disease and new avenues are being explored for treating early ischemic injury by anti thrombolytic agents ,neuroprotectants ,antioxidants etc followed by physical rehabilitation ,physiotherapy etc. Yet the disease has not been dominated and remains incurable. To add it up, the adverse effects pose distant threat to the well being. Therefore, the Ayurvedic therapeutics have attracted considerable superiority for providing safe and effective remedies.
In Ayurvedic classics, for vata dosha, Snehana, Svedana, Mrudusamsodhana are selective therapies. Nasya karma does have a role in Pakshaghatha, since there is a vikrithi in the masthishka and marmasthana. Bhunaga thaila will be used for Nasya karma as well as internally, along with Dhanadanayanadi kashaya as anupana. Bhunaga thaila is an ‘Anubhutha yoga’, specially indicated in Pakshaghatha. It has the effect to prevent formation of thrombosis, prevent blood clotting, destroying thrombus and normalizes the metabolism of human body cells. Abhyanga swedana(sthanika) will be done for Pakshaghatha with Ksheerabalathaila, it nourishes the sushkadhathu and does balavardhana.
Here, 30 patients will be selected for the study as one group, who will receive Bhunaga thaila Nasya, Pana along with Dhanadanayanadi kashayam and Sthanika abhyanga with Ksheera bala thailam followed by swedanam.
6.2 Review of literature.
1 .Explanation of Pakshaghatha.1,2,3
2 .Explanation of Hemiplegia.4,5,6,7
3 .Management of Stroke.8
4. Nasya karma9
5. Bhunaga thailam.10
6. Dhanadanayanadi kashayam.11
7 .Abhyanga(sthanika) swedana.12
8. Ksheerabala thailam.13
PREVIOUS WORK DONE.
1.Dr.Deshmukh.A.- Therapeutic effect of Vishmushti with Shodhana Karma and Physiotherapy in selected cases of Pakshaghatha.,B.K.R.R. Gov. Ayurvedic college, Hyderabad,1982.
2.Dr. Sarala.M.- Clinical observation of Pakshaghatha and its treatment with Kala Basthi using Sahacharadi thaila ,Gov. Ayurvedic college,Trivandrum, 1986.
3.Dr.Sreena.G.- A clinical study on the effect of Yogaraja guggulu followed by Maashaathmaguphadi kwatha along with Virechana Karma on Pakshaghatha.B.K.R.R. Gov.Ayurvedic college, Hyderabad,1993.
4.Dr. Arora P.N.- A clinical comparative study of Basthi chikithsa and snehapana in the management of Pakshaghatha (Hemiplegia),Gov.Akhandanad Ayurvedic college, Ahmedabad,1995.
5.Dr. Goyal Ravikanth- A clinical study on the role of Karma Basthi, Mashadi kwatha and Mashadi thaila in the management of Pakshaghatha(Hemiplegia).I.P.G.T. and R Gujarath University,Jamnagar, 2000.
6.Dr.Sudhir Raj.N.- A clinical study on Pakshaghatha(hemiplegia), Ayurveda Mahavidyalaya,Hubli.R.G.U.H.S, Bangalore,2001.
7.Dr Durkal Krupali.A.- A comparative study of Shodhana Purvaka Shamana(virechana) and Shamana chikithsa in the management of Pakshaghatha(Hemiplegia), Gov. Akhandanad Ayurvedic college, Ahmedabad,2004.
8.Dr. Bhujabala S.K.- Studies on pakshaghatha and its management with Mathra Basthi, Prathimarsa nasya and Siropichu.R.K Toshniwal Ayurveda Mahavidyalaya, Akola,2004.
9.Dr.Gagan Thakur- A clinical evaluation of Panchakarma in management of Pakshaghatha(Hemiplegia),R.G.Gov. PG Institute of Ayurveda, Paprola,2004.
10.Dr.Rahul Kumar - Comprehensive Management of Pakshsghatha(Hemiplegia), Ayurveda Mahavidyalaya, Hubli,R.G.U.H.S,Bangalore, 2009.
6.3.OBJECTIVES OF STUDY.
1. To study Pakshaghatha in detail according to Ayurveda Acharya.
2. To study in detail about Hemiplegia according to Modern medicine.
3. To assess the effect of Bhunaga thaila Nasya in the management of Pakshaghatha.
4. To assess the effect of Bhunaga thaila pana along with Dhanadanayanadi Kashayam in the management of Pakshaghatha.
5. To assess the effect of Sthanika abhyanga with Ksheerabala Thailam followed by Swedanam.
[ B ] VII. MATERIALS AND METHODS.
The present study titled “A COMPREHENSIVE MANAGEMENT OF PAKSHAGHATHA(HEMIPLEGIA) THROUGH BHUNAGA THAILA AND KSHEERABALA THAILA ” is a clinical trial to assess efficacy of Bhunaga thaila Nasya, Pana along with Dhanadanayanadi kashaya and Ksheerabala thaila Abhyanga (sthanika) followed by Swedanam.
7.1.SOURCE OF DATA
The patients attending the OPD and IPD of PG department of Kayachikithsa, Ayurveda Mahavidyalaya Hospital, Hubli will be taken for study.
7.2.METHOD OF COLLECTION OF DATA.
a) The patients attending the OPD and IPD, PG Department of Kaya Chikithsa, Ayurveda Mahavidyalaya Hospital, Hubli will be put on clinical trial.
b) Clinical evaluation of patient will be done by collection of data/information obtained by history, clinical findings obtained by physical examination and laboratory test.
c) Review of literature will be collected from library of PG Department of Kayachikithsa, Ayurveda Mahavidyalaya, Hubli will be taken for study.
d) Information regarding the topic will be collected from authentic journals and websites.
e)The drugs required for the clinical study will be procured and prepared in the department of Rasa Shastra and Bhaishajya Kalpana, Ayurveda Maha Vidyalaya, Hubli.
INCLUSION CRITERIA
1) Subjects with classical features of Pakshaghatha (Hemiplegia).
2) Subjects from both the sexes and of age group between 20-60 yrs.
3) Chronicity < 6 months.
4) Subjects fit for Nasya Karma.
EXCLUSION CRITERIA
1) Subjects less than 20 years, more than 60yrs of age and with chronicity more than 6 months.
2) Subjects with uncontrolled metabolic disorders, Malignant Hypertension and other systemic disorders.
3) Subjects with HIV, HbsAg positive , Comatose, and Degenerative disorders of brain.
4) Subjects with Intra cranial infectious disease and head injuries.
5) Pregnant women.
6) Subjects unfit for Nasya Karma.
PARAMETER OF STUDY.
SUBJECTIVE PARAMETERS.
1) Akarmanyatha - Reduced or loss of function of the effected side.
2) Vaksthambhathva - Difficulty in speech.
3) Visoshanatha - Muscle wasting.
OBJECTIVE PARAMETERS.
1) Higher Mental Functions.
a) Appearance and behavior.
b) Memory - Short term and long term.
c) Orientation.
d) Intelligence.
2) Nervous system examination.
a) Deep tendon Reflexes, Superficial Tendon Reflexes, Plantar and Knee jerk Reflexes.
b) Bulk, Tonicity and Power of Muscles.
c) Gait and Posture.
d) Hand grip.
Assessment criteria.
Improvement in subjective and objective parameters of Pakshaghatha(Hemiplegia), before and after the treatment.
The results will be categorized as,
- Marked relief - Above 75% improvement.
- Moderate relief - 50% - 75% improvement.
- Mild relief - 25% - 50% improvement.
- No relief - Below 25% improvement.
The data which are obtained by the clinical trial will be statistically analyzed by applying Student ‘t’ test.
SYUDY DESIGN: A clinical study.
Sample Size.
Minimum of 30 cases diagnosed as Pakshaghatha(Hemiplegia) will be incidently selected and studied under one group.
Nidanaparivarjanam – Avoid vatakara aahara viharas, smoking, alcohol and mental stress.
Amapachana with Avipathikara churna 5 gms with Luke warm water twice daily, ½ an hour before food for 3 to 5 days till nirama lakshanas are found.
Nasyakarma(Marsha type) with Bhunaga Thailam for 21 days.
Sthanika abhyanga with Ksheera bala thailam followed by Swedana for 21 days.
Bhunaga Thailam 2ml twice daily along with Dhanadanayanadi kashayam 30ml as anupana for 45 days.
DURATION - 45 days.
FOLLOW UP - 3 months with fortnightly visit.
7.3 Does the study require any investigation or interventions to be conducted on patient or other human or animal? If so describe briefly
YES
INVESTIGATION
1) Blood - TC, DC, E.S.R, Hb%, FBS, PPBS, Lipid profile.
2) Urine - Albumin, FUS, PPUS
3) C T scan of brain will be done if necessary.
INTERVENTION
a)Samanaushadhi.
Bhunaga Thailam 2ml twice daily along with Dhanadanayanadi kashayam 30ml as anupana for 45 days.
b)Nasya Karma.
Mukhabhyanga with Ksheerabala Taila and Baashpa sweda will be performed initially as Poorva Karma, and then Nasya Karma with Bhunaga Thaila will be done for 7 days followed by appropriate Paschat karma (Dhooma paana and Sukhoshna jala gandusha) and by 7 days of Parihara Kala,for the first course.
After 7 days of Parihara Kala the same Nasya procedure will be repeated with the same Thaila for 7 days as mentioned above, after which 7 days of Parihara Kala will be followed again for the second course. Again after parihara kala ,7 days of Nasya karma will be done followed by 7 days of parihara Kala, for the third course.
c)Sthanika Abhyanga Swedana.
Abhyanga of the effected side will be done with Ksheerabala thailam for 1hr. After that, Nadiswedana will be done for 21 days.
7.4 Ethical clearance has been obtained from your institution ?
YES
Ethical clearance has been obtained by the Ethical committee constituted by AYURVEDA MAHAVIDYALAYA, HUBLI and written consent will be taken by each individual patient or by an attendant if the patient is illiterate, on a printed consent form.
[ C ] VIII LIST OF REFERENCES
- Pt Kashinath Sasthri and Dr Gorakhnath Churrivadi,Agnivesa, Charaka Samhitha with Hindi commentary, Reprint,Chaukhambha Bharti Academy, Varanasi, 2002, p787.
- Kaviraj Ambikadatta Sastri, Susrutha Samhitha part one, Chaukhambha Sanskrit Sansthan, Varanasi, 2005,p233.
- Prof Yadunandana Upadhyaya, Madhava Nidana with Madhukosha commentary Part one, Edition 31, Chaukhambha Sanskrit Bhavan, Varanasi,2002,p473.
- Bannister Roger, Brainand Bannister’s Clinical Neurology,7th Edition,Oxford University press, Oxford,2001,P101-104.
- Christopher Haslett, John A.A. Hunter et al, Davidson’s Principles and Practice of Medicine, 19th Edition, Churchill Living stone, New York,2002,PN 1159-1166.
- E.C.Warner,Savill’s system of Clinical Medicine, 14th edition,CBS Publications,1998, p1183-1192.
- Sainani G.S.et al,A.P.I.Text Book of Medicine,6th edition, Association of Physician of India, Mumbai, 1999,P748-762.
- Christopher Haslett, John A.A. Hunter et al, Davidson’s Principles and Practice of Medicine, 19th Edition, Churchill Living stone, New York,2002,PN -1166.
- Pt Kashinath Sasthri and Dr Gorakhnath Churrivadi,Agnivesa, Charaka Samhitha with Hindi commentary, Reprint,Chaukhambha Bharti Academy, Varanasi, 2002,pn.1072.
- Ayurvedacharya Dr. M. Vishveshwara Sasthri, H.P.I.M, Vaidya Yoga Rathnavali(Formulary of Ayurvedic Medicines), IMPCOPS,Madras,5th edition,2000,P.N439,440.
- Dr. Ramnivas Sharma and Dr Surendra Sharma, Sahasra Yoga, Chaukhambha Sanskrit Pratisthan, Delhi,3rd edition,2002,p.n.3.
- Pt Kashinath Sasthri and Dr Gorakhnath Churrivadi,Agnivesa, Charaka Samhitha with Hindi commentary, Reprint,Chaukhambha Bharti Academy, Varanasi, 2002.
- Dr. Ramnivas Sharma and Dr Surendra Sharma, Sahasra Yoga, Chaukhambha Sanskrit Pratisthan, Delhi,3rd edition,2002,p.n.75.