Rajiv Gandhi University of Health Sciences s130

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA – BANGALORE

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT KAYA CHIKITSA FOR DISSERTATION OF MD AYURVEDA

“A CLINICAL EVALUATION OF BALAKULATTHADI KWATHA AND DRONAPUSHPI TIKSHNA NASYA ON PAKSHAGHATA (ACUTE ISCHEMIC STROKE)”

BY JAYAGOVINDA U M.D SCHOLAR DEPT. OF PG STUDIES IN KAYACHIKITSA MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES MANIPAL - 576104

GUIDE Dr. SHRIPATHI ACHARYA M.D (AYU). PhD PROFESSOR & HEAD, DEPT. OF PG STUDIES IN KAYACHIKITSA MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES MANIPAL - 576104

2012-2013 MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES MANIPAL- 576104, KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of Candidate : JAYAGOVINDA U

Address (In Block letters) : MD SCHOLAR DEPARTMENT OF KAYACHIKITSA MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES MANIPAL- 576104

Permanent Address : JAYAGOVINDA U POST UKKINADKA VIA PERLA, KASARAGOD DISTRICT KERALA-671552

2. Name of Institution : MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES MANIPAL -576104

3. Course of Study and Subject : MD (AYURVEDA) IN KAYACHIKITSA

4. Date of Admission of course : 31 OCTOBER 2012

5. Title of the Topic

“A CLINICAL EVALUATION OF BALAKULATTHADI KWATHA AND DRONAPUSHPI TIKSHNA NASYA ON PAKSHAGHATA (ACUTE ISCHEMIC STROKE)” 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 Need for study: Cerebrovascular accident is the third most common cause of death worldwide1. The incidence of stroke is more in developing countries than in developed one. The incidence of stroke is increasing day by day because of the sedentary life style and change in food habits. Even though the treatment modalities have improved enormously in modern medicine, due to the cost and lack of facility especially the people of rural area are not getting the timely treatment and suffers a lot. As Ayurveda practitioners are practicing more in rural area, this will be an opportunity for Ayurvedists if we get better treatment modality with better result. The main approach of the present practice in ischemic stroke is to improve the blood supply to the penumbra area by improving the collateral circulation and by removing the obstruction in the affected blood vessel. The area of the brain with lack of blood supply but with enough blood supply for the survival of the brain tissue is called as penumbra2. Ayurveda having many time tested medicines it is our duty to search for such herbs or herbal combination and shodhana therapies to achieve the better result. By seeing the previous studies it is evident that the affect of Balakulatthadi kwatha and Tikshna Nasya have not been observed in Ischemic stroke. Balakulatthadi kwatha is indicated in Pakshaghata. Our ancients had limited knowledge of brain and its relation with Pakshaghata, but today we know that the main pathology is in the brain. If we apply the same knowledge with the basic concepts, Tikshna Nasya which is indicated mainly in Urdhwajathrugatha vyadhis should also benefit the patients of acute ischemic stroke; it is also said that nose is the gateway of head.

6.2 Review of the literature: Pakshaghata is explained in our texts under Vata vyadhi context in Susrutha Nidana 1st Chapter3. Susrutha’s explanation is very much near to the present understanding. According to Susrutha ‘due to the etiological factors the aggravated vata dosha obstructs the dhamanis moving upwards, downwards or to the sides in any one side of the body and results in loss of movement in any one side of the body. Charaka also explains Pakshaghata under Vathavyadhi chikitsa Chapter 294. In Astanga Hridaya Pakshaghata is explained under Vathavyadhi nidana chapter 155. The treatment of Pakshaghata is also explained in Susrutha, Charaka samhitha and Astanga Hridaya. In Laghu thrayees also we can see the treatment methods of Pakshaghata. Here we consider only acute ischemic stroke for our study purpose which comes under Pakshaghata. Ischemic stroke is caused by carotid artery obstruction, cerebral artery occlusion (Middle Cerebral Artery, Anterior Cerebral Artery or Posterior Cerebral Artery), thrombo embolic stroke, thrombotic stroke and water shed ischemia. In Ayurveda we can also consider stroke under the heading of Samanavritha Vyana vayu6. Here the brain center responsible for body movement which is controlled by vyana vayu is obstructed by obstructed peripheral blood supply which is controlled by Samana vayu. Charaka while explaining the symptoms explains Murcha, Tandra. Pralapa, Agni, oja and Bala kshaya, which are also the main symptoms seen in stroke. Alpa bhojana and vyayama are the treatment mentioned by Charaka which is also the main line of treatment followed even today in stroke. Depending upon the signs and symptoms we should also consider the Samana avarana of Prana Vayu, Udana vayu and Apana Vayu. Here we should also consider the samanya vatha vyadhi chikitsa along with treatment of Avaraka followed by avritha. That is removing the obstruction which in turn saves the dying brain cells, followed by treating the neurological deficits. Balakulatthadi Kwatha7: The Ingredients are Bala, Kulattha, Sahachara, Pippalimula, Punarnava, Masha, Godhuma, Jivanthi, Devadaru and Harithaki. The Ingredients Bala, Sahachara, Devadaru are well known Vatahara drugs. Punarnava, Devadaru, Kulatha, and Sahachara have Muthrala guna which helps in reducing brain edema and also helps in slow fall in blood pressure. Harithaki being very good anulomaka and also mrudu virechaka helps to relieve constipation which is very common in acute stroke, other than this, the main indication for Balakulathadi Kashaya yoga is Pakshaghatha as explained in Sahasrayoga. Dronapushpi: Reference for indication in Pakshaghatha8 ‘Dronpushpeekatusoshnaa ruchyaavatha kaphaapahaa Agnimaandyaharachaiva PAKSHAGHATAsyanaashinee|| -Shaligrama nighantu (from shodala nighantu), guduchyadi varga Reference for Nasya9 Dronapushpi ‘Harathi Patalamakshnosthandulaambuprapishtaa Sichayagalithasaaraa NAAVANAAD dronapushpee|| Bhavaprakasha Nighantu, guduchyadi vargaha, from Shodala nighantu. Here dronapushi is taken for evaluation because of its Tikshna guna and also Pakshaghathahara guna. Pakshaghatha being a disease related to brain, a dravya having pakshaghathahara guna should act when used through nose.

PREVIOUS WORKS DONE: 1. Gupta R S.- Pakshagatha Roga Vimarsha nidana: chikitsatmaka adyayana (shathavaryadi Guggulu prayoga), Rajasthan university Jaipur in 1975 2. Deshamukha A, A therapeutic effect of Suddha vishamusti with Shidhan karma and physiotherapy in selected cases of Pakshaghata, Govt. Ayurvedic college Hyderabad in 1982. 3. Patel AK.- Pakshagata men chikista Ka Prayogika adhyaya Gujarat Ayurveda university Jamnagar in 1983 4. Vivekananda - A clinical study of effect of shastikashali panda sweda on Pakshaghata, Govt. Ayurvedic college, Hyderabad in 1985. 5. Vishwakarma - A clinical study of the effect of virechana and Basthi on Pakshavadha with scientific evaluation, Govt. Ayurvedic college, PT Ravishankar University, Raipur in 1985. 6. Desai K R. - Comparitive study on the efficacy of Bruhadvata chintamani Rasa on the Pakshaghata. Gujarat Ayurveda University Jamnagar in 198710. 7. Chandra.T.- Pakshagat menArdanga vatari Rasa ka chikitsatmaka Adhyayam, Rajasthan university –Jaipur in 1987 8. Yagnik. A.K.- Pakshagate snehapanam, Gujarat Ayurveda university Ahamedabad in 1989. 9. Mishra H P.- Study on the effect of Hingu Triguna Taila in the treatment of Pakshaghata, Gopabandha Ayurveda Mahavidyalaya, Puri in 1991 10. Suman P R.- Study on Lashuna Rasayana with special reference to Pakshavadha, Kerala University, Thiruvananthapuram in 1992 11. Panwar K.S.- A clinical study on charakokta management of pakshaghata (Hemiplegia). Gujarat ayurveda university Jamnagar in 1994 12. Arora (M S) P.N.- A Clino-comparitive study of Basti chikista and Snehapanam in the management of Pakshagatha (Hemiplegia) Gujarat Ayurveda university Ahamedabad in 1995 13. Gajanana Kulakarni, A comparative study of role of yapana basti and Karma basti in the management of pakshaghata, Gujarat Ayurved University Jamnagar in 2007

6.3. Objective of the study: 1. To study the etiopathogenesis of Pakshaghata with reference to ischemic stroke. 2. To study the effect of Balakulatthadi kwatha and Dronapushpi tikshna nasya on pakshaghata (acute ischemic stroke) 3. To compare the effect of Balakulatthadi kwatha and Dronapushpi Tikshna Nasya with Shastikashali Pindasweda on Pakshaghata.

7. MATERIALS AND METHODS 7.1 Source of data: Patients diagnosed as Pakshaghata (Acute ischemic stroke) will be taken for study from OPD and IPD of MIAMS MANIPAL.

7.2 Method of collection of data: A special Performa will be prepared with details of history taking, physical signs, symptoms and lab-investigations based on classics and allied sciences. Patients will be analyzed and selected accordingly. The subjective and objective parameters will be scored on the basis of standard method and will be analyzed statistically. Consent from the patients: Prior written consent will be taken from the patient before subjecting him to the procedures.

Design of the study: A single blind clinical study with pre-test and post-test design will be carried out, where in a minimum of 30 patients suffering from acute ischemic stroke of either sex will be selected. 30 patients will be divided in to two groups of 15 each test and standard group. In the first group (test), the selected 15 patients will be subjected Balakulathadi kwatha and Dronapushpi swarasa Tikshna Nasya: 1. Balakulatthadi kwatha 50 ml twice daily, in the morning and at night preferably after food. This will be given continuously for 14 days as inpatient and will be given for 16 days. 2. 0.5 ml of Dronapuspi swarasa as Tikshna nasya will be instilled to each nostrils 45 minutes after breakfast in the morning. Before this procedure Mukha abhyanga and bashpa sweda will be done as explained in texts. Tikshna Nasya will be performed continuously only for seven days as inpatient. Then onwards Tikshna nasya will be instilled on alternate days for next 7 days. Blood pressure of the patient will be recorded every time before and after instilling Tikshna Nasya. Method of preparation of medicines Balakulatthadi Kwatha: 50 g of kwatha churna will be taken and boiled in 800 ml of water and reduced to 100 ml. This kashaya will be prepared daily basis. Dronapushpi Nasya: Fresh leaves of Dronapushpi is washed with clean water and rinsed well. The grinded fresh juice will be extracted with the help of clean cloth. Maha masha taila will be used for Mukhabhyanga Bashpa sweda will be given with boiling water.

In the second group fifteen patients will be subjected to Shastikashali Pindasweda: Shastikashali Pindasweda: This procedure is conducted as explained in classical text. Selected 15 patients are subjected to Shastikashali Pindasweda continuously for 14 days. Abhyanga with Maha Masha Taila will be done for 45 minutes followed by Pindasweda for 20 minutes with special care to the paralysed side. Method of preparation: Shastikashali Pinda sweda: 50 grams of Bala churna is boiled in 2 liters of water and reduced to 500 ml then 250 ml of milk is added and again boiled for 10 minutes and continuously heated in low flame. Previously prepared rice of shastika shali is tied in a cloth and tied to get the pinda form. This bolus is then dipped in the above Bala ksheera kashaya for the purpose of phomentation.

Follow up: Follow up will be done after 30 days of starting treatment and 90 days after starting treatment. Statistical method used: Paired and unpaired T test will be used for the assessment.

Inclusion Criteria: 1. Acute ischemic stroke 2. Age below 60 years and above seven years. 3. Both males and females Exclusion Criteria: 1. Comatose and unconscious patients. 2. Hemorrhagic stroke. 3. Uncontrolled Diabetes. 4. Above the age of 60 and below the age of seven years. 5. Patients with cardio embolic stroke. 6. Patients with major cardiac illness like severe IHD, CAD, CCF etc 7. Hypertensive patients with BP >220/120mm of Hg. 8. All space occupying lesions including tumors, granulomas etc. 9. Meningitis, Encephalitis and other brain infections 10. Traumatic head injuries. 11. Congenital defects- diffuse sclerosis, cerebral agenesis and other major illness.

Assessment Criteria: The improvement in the patients was assessed on the basis of the criteria given below. 1) Speech-

Aphasia 4 Utter voice 3 Speaks few words 2 Speaks with difficulty 1 Normal speech 0

2) Facial expression- Ask the patient to show teeth or to raise eyebrows, smile and to close eyes. Score according to the symmetry of face. Severe weakness, drooling 3 Moderate loss; asymmetry at rest 2 Mild weakness; asymmetry on smiling 1 Normal 0

3) Motor function at- Upper limb proximal Upper limb distal Lower limb proximal and Lower limb distal Patients were asked to keep their limbs straight and to perform some movements. If there was some movement further limb power at every joint was assessed against gravity and resistance as well.

No movements at all 5 Trace movement only 4 Motion without gravity only 3 Moves against gravity but not against resistance 2 Positive drift of arm/leg 1 Normal 0

4) Modified Ranking scale- Dead 6 Severe disability, bedridden, incontinent and requiring constant 5 nursing care and attention Moderately Severe disability, unable to walk without assistant 4 and unable to attend to own bodily needs without assistant Moderate disability, requiring some help, but able to walk 3 without assistant Slight disability, unable to carry out all previous activities, but 2 able to look after own affairs without assistant No significant disability despite symptoms able to carry out all 1 usual duties and activities No symptoms at all 0

5) Drooping wrist- Full drooping 3 Moderate drooping 2 Slight drooping 1 No drooping at all 0

6) Sitting from lying down- Unable 2 With support 1 Without support 0

7) Walking- Bed ridden 5 Walks with assistant 4 Walks with support like stick, wall etc. 3 Walks with slight help 2 Walks without support 1 Walks with speed 0

8) Lifting arm/shoulder/leg- No lifting at all 4 450 3 900 2 1450 1 1800 0

9) Finger movements- No movements at all 4 Slight movements 3 Unable to hold objects 2 Able to hold objects with less power 1 Normal 0

10) Depression- Severely depressed 2 Occasionally depressed 1 No Depression 0

11) Ruja (pain)- Frequent pain 2 Pain after exertion 1 No pain 0

12) Bhrama- Feeling of fall 3 Continuous Bhrama 2 Bhrama after sudden change of position 1 No Bhrama 0

13) Shrama (tiredness)- Shrama on slight exertion 2 Shrama on moderate exertion 1 No Shrama 0

14) Daurbalya- Severe 2 Mild 1 No Daurbalya 0

15) Vibandha (constipation)- Severe 2 Mild 1 No constipation 0

Statistical method used: Paired and unpaired T test will be used for the assessment.

7.3 Does the study require any investigation or intervention to be? Conducted on patient or other humans or animals? If so please Describe briefly. The Study will only be a human clinical study; no animal experiments will be conducted. Investigations: All the patients will be subjected to 1. CBC 2. FBS, PPBS 3. Renal function tests 4. Lipid profile 5. CT Scan Head 6. ECG 7. X Ray chest wherever necessary 8. MRI Brain wherever necessary

7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes, Concurrence has been obtained from the Institutional ethical committee.

8. List of reference : 1. Salvador Cruz Flores, Helmi L Lustep, Ishcemic Stroke. Updated April 8, 2013. Emedicine medscape. http://emedicine.medscape.com/article/1916852- overview#a0156 2. Salvador Cruz Flores, Helmi L Lustep, Ishcemic Stroke. Updated April 8, 2013. Emedicine medscape. http://emedicine.medscape.com/article/1916852- overview#aw2aab6b2b4 3. Sushrutha, Ayurveda tattva sandipikia commentary by Ambikadatta shastri. Susrutha samhitha. vol 1. 9th edition. Varanasi: Chukhamba Samskritha samsthana; 1995. Pp-303, p233. 4. Agnivesha. Brahmanadna Tripathi, elaborated by Charaka and Dridhabala. Charaka Samhitha. vol 2. 3rd edition. Varanasi: Chaukhamba Surbharathi Prakashan; 1991. Pp-1450, p946. 5. Vagbhata, K R Srikantha Murhty. Astanga Hridayam. Vol 2. 2nd edition. Varanasi: Krishnadas Academy; 1995, Pp-596, p155. 6. Agnivesha. Brahmanadna Tripathi, elaborated by Charaka and Dridhabala. Charaka Samhitha. vol 2. 3rd edition. Varanasi: Chaukhamba Surbharathi Prakashan; 1991. Pp-1450, p976. 7. Kaikulangara Rama Vairier. Arogyakalpadrumam. 1st edition. Kollam: S. T. Redwar and Sons; 1931. Pp-666, p-303 8. Somadasa Srikrishnadasa. Shaaligrama nighantu. 1st ed.Mumabi: Srivenkateshwara steam yanthralaya; 1934. Pp-1256, p464. 9.Bhavamishra. Ambikadatta shastry, editor. Bhavaprakasha nighntu. 1st ed. Banaras: Chaukhamba samskritha series; 1940. Pp-750, p340. 10. Dr M S Baghel, Researches in Ayurveda. 1st ed. Jamnagar: Mridu Ayurvedic Publication and sales; 1997. Pp-303, p40.