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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

COMPLETED PROFORMA FOR THE REGISTRATION OF SUBJECT

(MANASAROGA) FOR THE DISSERTATION IN M.D (AYURVEDA)

“A CLINICO-PHARMACOLOGICAL STUDY TO EVALUATE NEURO-

PROTECTIVE ACTIVITY OF BRIHAT VATA CHINTAMANI RASA AND ITS

ROLE IN MANAGEMENT OF POST STROKE DEPRESSION”

BY

DR. VIKRAM C.

PRELIMINARY M.D. (Ayu) SCHOLAR

DEPARTMENT OF PG STUDIES IN MANASAROGA

S.D.M. COLLEGE OF AYURVEDA & HOSPITAL,

HASSAN -573201, KARNATAKA

GUIDE

DR. NARAYANA PRAKASH .B. M.D (Ayu), Ph.D

HOD AND PROFESSOR

DEPARTMENT OF PG STUDIES IN MANASAROGA

CO-GUIDE

Dr. RAVISHANKAR B M.Sc, Ph.D

DIRECTOR

SDM RESEARCH CENTRE FOR

AYURVEDA AND ALLIED SCIENCES,

UDUPI

2011-2012

S. D. M. COLLEGE OF AYURVEDA & HOSPITAL,

HASSAN, KARNATAKA

FROM,

VIKRAM C

Preliminary M.D (Ayu) Scholar,

Department of Manasaroga

S.D.M. College of Ayurveda and Hospital,

HASSAN- 573201.

TO,

THE REGISTRAR,

Rajiv Gandhi University of Health Sciences Karnataka,

BANGALORE, Karnataka.

THROUGH,

The Principal and Head of the Dept. of Manasaroga,

S.D.M. College of Ayurveda and Hospital,

Hassan- 573201.

Subject: Submission of Completed Proforma for Registration of Synopsis of Dissertation.

Respected Sir,

I request you to kindly register the below mentioned subject against my name for the

submission of the dissertation to Rajiv Gandhi University of Health Sciences Karnataka,

Bangalore, for the partial fulfillment of M.D. (Ayurveda) in Manasaroga.

THE TITLE OF DISSERTATION:




Herewith I am enclosing a completed Proforma of synopsis for registration of subject for

Dissertation.

Thanking you,

Yours faithfully,

Place: Hassan

Date: 30/03/12 (DR. VIKRAM C)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE.

ANNEXURE - II

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION.

1. NAME OF THE CANDIDATE : VIKRAM C

AND ADDRESS : PRELIMINARY M.D (AYU) SCHOLAR.

(IN BLOCK LETTERS) DEPT. OF MANASAROGA,

S.D.M. COLLEGE OF AYURVEDA

AND HOSPITAL, HASSAN – 573201

PERMANENT ADDRESS : VIKRAM C

ANNAMALAI NILAYAM,

MADHAVANAGAR,

2ND STAGE, T K ROAD,

BHADRAVATHI-577301,

KARNATAKA

2. NAME OF THE INSTITUTION : S.D.M. COLLEGE OF AYURVEDA

& HOSPITAL, HASSAN – 573201

3. COURSE OF STUDY & SUBJECT : M.D. (AYURVEDA) MANASAROGA

4. DATE OF ADMISSION TO

THE COURSE : 12TH AUGUST 2011

5. TITLE OF THE TOPIC :




6) BRIEF RESUME OF THE INTENDED WORK:

6.1) NEED FOR STUDY:

Stroke is the third leading cause of death and the most common disabling disease, which

has an enormous emotional impact on both patients and their family members.1 Depression is an

important consequence of stroke, and it influences stroke recovery.2-14 In spite of this, there are

only a few population-based studies of the incidence and severity of depression after stroke in

patients.6,13 27%15 and 22%16 rates of depression have been reported in the first week after stroke,

and the prevalence falls only slightly over the next six months17,18,19,15 or one to two years16,20.

Some long term survivors may, however, have lower rates of depression.19 Depression is found in

about 15% of the elderly at home,21-23 and so depression may be almost twice as common among

patients in the first year after stroke as among the normal elderly population. Stroke can be

understood under the heading of Pakshaghata in Ayurveda. Pakshaghata is considered as one of

the Vatavyadhi, which is Mahagada.24 Vata has direct impact on mind for its normal function

like Niyanta Praneta of Manas.25 Aggravated Vata vitiates Manasika Doshas too and manifests

Manovyaharsha.26 Brihat vata Chintamani Rasa is mentioned in Vatavyadhi Adhikara. Brihat

Vata Chintamani Rasa is widely used in the management of vatavyadhi27 vis-a-vis

Neuropsychiatric illnesses. This implicates that it helps in balancing the Vata dosha and

Manasika dosha too. The ingredients of Brihat Vata Chintamani Rasa are Vatahara and Manasika

Doshahara, hence may helpful in counteracting psychological symptoms along with physical

symptoms.

The ingredients of Brihat Vata Chintamani Rasa are Swarna Bhasma which has

properties like Buddhimedha Smrutikara, Vakvishuddhikara, Unmada Prashamana, Chinta

Shoka, Bhaya, Krodha, Bhutamaya and Vaichitya nashanam qualities, propagates Raktha

Sancharana in Shirodeshas;28 Raupya is Medhya in nature,29 Abhraka – Prajnabhodhi,30 Loha

bhasma is Soukhyala, and Sarvavyadhihara,31 Pravala has the property of Visha Bhutadi

Shamana,32 Mukta is Medha Buddhi Vardhana.33 By analyzing the ingredients of Brihat vata

Chintamani Rasa it is evident that the formulation may also be used in Manasika vikaras

manifests as a sequel of Vata Vyadhi especially Pakshaghata.

Neuro-Pharmacological actions of Gold & Silver are experimentally proven as

Neuroprotective by stimulating cerebral functions and Mental Exhilaration.34-39 Bruhat Vata

Chintamani Rasa also contains these as the constituents hence it is planned to see the

antidepressant and Neuro protective action in animal models.

Brihat vata Chintamani Rasa is most commonly prescribed Shamana aushadhi for

Pakshaghata and sequel of Pakshaghata. Though commonly used medicine but only few research

works has been conducted. Hence Brihat Vata Chintamani Rasa is taken in the current study to

assess Neuro-protective activity and its efficacy in the management of post stroke depression.

6.2) REVIEW OF LITERATURE:

Acharya Charaka listed Pakshavadha under eighty Nanatmaja Vata Vikaras.40

Pakshavadha or Pakshaghata is considered among the ailments of Madhyama Roga Marga, i.e.,

Marma-Asthi-Sandhi Marga.41 Detailed description of the disease has been given as

Pakshavadha.42 Acharya Sushruta has highlighted Vata Vyadhi among Ashta Mahagadas43 and

the involvement of Urdhvagami, Adhogami and Tiryagami Dhamanis in the pathogenesis of

Pakshaghata with cardinal symptoms like Anyatara Pakshahanana and Sandhi Bandhana

Vimoksha. In aetiopathogenesis, clinical features and prognosis of Pakshaghata are described.44

Treatment of Pakshaghata is described in Maha Vata Vyadhi Adhyaya of Chikitsa Sthana.45

Acharya Vagbhatta has explained the general Nidana of Vata Vyadhi, signs, symptoms and

prognosis of Pakshaghata.46 Line of treatment is same as that given by Charaka with the only

difference that Sneha is mentioned instead of Swedana.47

In Bhaishajya Ratnavali detailed Chikitsa of Vatavyadhi has been described in chapter

named as Vata Vyadhi Chikitsa. Some drug formulations are also indicated for Pakshaghata,

among which Brihat vata Chintamani Rasa has been described as Pittahara, Vatarogahara,

Kandarpa, in Vruddha makes him Tarunaspardhi.25 It contains Swarna, Raupya, Abhraka, Loha,

Pravala, Mukta, Pravala, Rasasindhoora, which is triturated with Kumari Swarasa.

Swarna has the property of Buddhi, Medha, Smrutipradam, Vakvishuddha, Unmada

prashamana, Rasayanam, Soumyam, Chinta, Shoka, Bhaya, Krodha, Bhutamaya nashanam,

propagates Raktha Sancharana in Shirodesha, Vaichityam, Yoshaapasmara, Chittiodvega, Brama

Nashanam, in Praksheena Medha Smruthi.28 Raupya has the property of Medhya, Vatahara,

Rasayanam, and Sarvarogahara.29 Abhraka having Prajnabhodhi, Vata & Pittahara,

Sarvarogahara.30 Loha has soukyala, Sarvavyadhihara, Rasayana, Soukya.31 Pravala has the

property of Visha bhutadi shamanam.32 Mukta acts as Medhya Buddhi vardhanam.33

Stroke is a common disease with severe implications for the patient as well as his or her

family. Besides reduced survival and physical impairments after stroke, it may also affect

cognitive functions and quality of life. Post stroke depression, being the most common mood

disorder after stroke, has been reported in both less than 25% and more than 75% of individuals

with stroke.48 Detecting and treating post stroke depression is important, because it has negative

effects on functional recovery. Post stroke depression is also associated with poor psychological

outcome and poor quality of life.49

6.3) PREVIOUS WORK DONE:

1. Sheeja.G, Kottakkal (2008)- A Study on Post Stroke Depression And Its Managment

With Brahmi Taila Nasyam & Psychotherapy.

2. Malagi K. J, Jamnagar (1985) -A comparative study on the role of Virechana and

Bruhat Vata Chintamanai Rasa in the management of Pakshaghata (Hemiplegia).

3. Desai K. R, Jamnagar (1987) - Comparative study on the efficacy of Bruhat Vata

Chintamanai Rasa on Pakshaghata.

6.4) OBJECTIVE OF THE STUDY:

To assess the effect of Brihat Vata Chintamani in the management of post stroke

depression disease.

To evaluate Neuro-Protective effect of Brihat Vata Chintamani in experimental models.

7) MATERIAL AND METHODS:

A) CLINICAL STUDY

7.1) SOURCE OF DATA:

Patients of Post Stroke Depression will be selected for study from the I.P.D. and O.P.D

of S.D.M.College of Ayurveda & hospital, Hassan.

7.2) METHOD OF COLLECTION OF THE DATA:

A. CRITERIA OF DIAGNOSIS:

For diagnosis detail medical history will be taken and physical examinations will be done in

detail according to both Ayurvedic and Modern clinical methods. A detail interview will be

conducted to elucidate psychological problems, social problems and other areas of functioning

etc. The diagnostic guidelines mentioned in DSM-IV-TR diagnostic criteria for mood disorder

due to general medical condition (stroke) with depressive features will be followed.

Sl No. Features

1. Depressed mood/ diminished interest or pleasure(in all or almost all activities)

2. Disturbance is the direct physiological consequence of a general medical

condition(Stroke)

History/lab/CT/MRI/Others

3. Disturbance is not due to another mental disorder

4. Disturbance does not occur exclusively during the course of Delirium

5. Symptoms cause clinically significant distress/ impairment in social,

occupational or other impairment areas of functioning

CRITERIA FOR DEPRESSIVE FEATURES

Sl No. Features

1. Depressed mood most of the day

2. Diminished interest or pleasure in almost all activities(nearly every day)

3. Significant weight loss/ weight gain (more than 5% body weight in a month)

decrease/ increase in appetite nearly every day

4. Insomnia/ hypersomnia nearly every day

5. Psychomotor agitation/ retardation nearly everyday

6. Fatigue/ loss of energy nearly everyday

7. Feeling of worthlessness, Helplessness & Hopelessness

8. inappropriate guilt nearly everyday

9. Diminished ability to think or concentrate or indecisiveness

10. Recurrent thoughts of death, suicidal ideations with or without plans, suicidal

attempts

11. Symptoms do not meet the criteria for a mixed episode

12. There is clinically significant distress or impairment in social, occupational or

other areas of functioning

13. Symptoms are not better due to bereavement(due to grief etc)

14. Diurnal mood variation.

15. Irritability

To assess the psychological intactness, Mental status examination and Manasika Bhavas

pareeksha will be carried out. To confirm or exclude the other medical disorders, routine

hematological and urine investigations will be carried out.

B. INCLUSION CRITERIA:

1. DSM-IV-TR diagnostic criteria for mood disorder due to general medical

condition (stroke) with depressive features.

2. Age groups 35-70 years of either sex, no discrimination of race, religion.

3. Patients within a period of 2weeks to 5 years after stroke.

4. Patients of HTN & DM.

C. EXCLUSION CRITERIA:

1. Patients with history of hereditary or previous mental disorders.

2. Associated with CHD.

3. Unconscious & coma patients.

4. Intracranial infections such as Meningitis.

5. Space occupying lesions of brain such as tumors.

6. Stroke due to RTA, traumas.

7. Congenital defects – diffuse sclerosis, cerebral agenesis, etc & other major illness.

Events promoting depression other than the impact of stroke.

D. STUDY DESIGN:

It is an exploratory clinical study. 30 diagnosed patients willing to participate in the

study, fulfilling the inclusion criteria will be selected and administered market available sample

of Brihat Vata Chintamani Rasa in the dose of 125mg twice daily before food for a period of 15

days with honey.

E. CRITERIA FOR ASSESSMENT:

Assessment is done using Hamilton’s depression rating scale, NIH Stroke Scale

and Manasika Bhava rating scale before and after treatment.

F. STATISTICAL ANALYSIS:

Statistical analysis of the results will be done by Paired ‘t’ test & ANOVA’s test.

G. DURATION OF STUDY: 15 days

H. FOLLOW UP: Patients will be asked to follow up study after 15 days completion of

treatment.

B) ANIMAL STUDY

The test formulation would be assessed for anti-depressant activity by noting the

effect of its administration on behavioral ‘despair’ anti-reserpine test and Dopa potentiation test.

Effect of test formulation on the behavioral and biochemical changes induced by carotid

artery occlusion induced global ischemia in Rats (Gross behavior and open field behavior) -

biochemical parameters – lipid peroxiation and glutathione, catalase and SOD activity in brain

homogenate.

7.2) ANIMAL EXPERIMENTATION

METHOD OF COLLECTION OF DATA (INCLUDING PROCEDURES IF ANY)

1. Healthy rats of either sex weighing between 150 to 250 g body weights will be taken for

the experimental study.

2. Pregnant rats will not be taken for the experimental study.

7.3) DOES THIS STUDY REQUIRES ANY INVESTIGATIONS OR INTERVENTION

TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

1. Routine blood & urine investigations.

2. LFT & RFT if necessary.

3. C T Scan of Head if necessary.

7.4) HAS THE ETHICAL CLEARANCE IS OBTAINED FROM YOUR INSTITUTION

IN CASE OF 7.2? YES

8) LIST OF REFERENCES:

1. Weinfeld DF. The National Survey of Stroke. Stroke. 1981; 12(suppl 1):1–91.

2. Folstein MF, Maiberger R, McHugh PR. Mood disorder as a specific

complication of stroke. J Neurol Neurosurg Psychiatry. 1977; 40:1018 –1020.

3. Robinson RG, Price TR. Post-stroke depressive disorders: a follow-up study of

103 patients. Stroke. 1982; 13:635– 641.

4. Sinyor D, Amato P, Kaloupek DG, Becker R, Goldenberg M, Coopersmith H.

Poststroke depression: relationships to functional impairment,coping strategities, and

rehabilitation outcome. Stroke. 1986; 17: 1102–1107.

5. House A. Depression after stroke. BMJ. 1987; 294:76 –78.

6. Wade DT, Leigh-Smith J, Hewer RA. Depressed mood after stroke: a community

study of its frequency. Br J Psychiatry. 1987; 151:200 –205.

7. Robinson RG, Bolduc PL, Price TR. Two-year longitudinal study of post stroke

mood disorders: diagnosis and outcome at one and two years. Stroke. 1987; 18:837– 834.

8. Parikh RJ, Lipsey JR, Robinson RG, Price TR. Two-year longitudinal study of

post stroke mood disorders: dynamic changes in correlates of depression at one and two

years. Stroke. 1987; 18:579 –584.

9. Starkstein SE, Robinson RG. Affective disorders and cerebral vascular disease. Br

J Psychiatry. 1989; 154:170 –182.

10. Robinson RG, Stark stein SE. Current research in affective disorders following

stroke. J Neuropsychiatry Clin Neurosci. 1990; 2:1–14.

11. Robinson RG, Morris PL, Fedoroff JP. Depression and cerebro-vascular disease. J

Clin Psychiatry. 1990; 51:26 –31.

12. Astro m M, Adolfsson R, Asplund K. Major depression in stroke patients: a 3-

Year longitudinal study. Stroke. 1993; 24: 976 –982.

13. Andersen G, Vestergaard K, Riis JO, Lauritzen L. Incidence of post-stroke

depression during the first year in a large unselected stroke population determined using

a valid standardized rating scale. Acta Psychiatr Scand. 1994; 90:190 –195.

14. Sharpe M, Hawton K, Seagroatt V, Bamford J, House A, Molyneux A,

Sandercock P, Warlow C. Depressive disorders in long-term survivors of stroke:

association with demographic and social factors, functional status and brain lesion

volume. Br J Psychiatry. 1994; 164:380 –386.

15. Robinson RG, Starr LB, Kubos KL, Price TR. A 2 year longitudinal study of post-

stroke mood disorder: findings during the initial examination. Stroke 1983; 14:736-41.

16. Wade DT, Smith JL, Hewer JL. Depression after stroke: a community study of its

frequency.Br J Psychiatry (in press).

17. Feibel JH, Berk S, joynt RJ. The unmet needs of stroke survivors. Neurology

1979; 29:592.

18. Feibel JH, Springer CJ. Depression and failure to resume physical activities after

stroke. Arch Phys Med Rehabil 1982; 63:276-8.

19. Robinson RG, Price TR. Post-stroke depressive disorders: a follow-up study of

103 patients. Stroke 1982; 13:635-40.

20. Ahlsio B, Britton M, Murray V, Theorell T. Disablement and quality of life after

stroke. Stroke 1984; 15:886-90.

21. Kay DWK, Beamish P, Roth M. Old age mental disorders in Newcastle upon

Tyne. Br 7 Psychiatry 1964; 11O:668-82.

22. Murphy E. Social origins of depression in old age. BrJ Psychiatry 1982;141:135-

42.

23. Gurland BJ, Copeland J. The mind and mood ofaging. New York: Croom Helm,

1983.

24. Acharya YT, Narayan Ram Acharya Kavya Tirtha. (ed). Susruta samhita with Nibanda

Sangraha commentary of Sri Dalhanacharya, 6th ed. Varanasi: Chaukambha orientalia; 1997.

P.144.

25. Acharya Y T. (ed). Charakasamhita of Agnivesha with Ayurveda Deepika commentary

of Chakrapanidatta.2011 reprint ed. Varanasi: Chaukamba Orientalia; 2011. p.79/80.

26. Acharya Y T. (ed). Charakasamhita of Agnivesha with Ayurveda Deepika commentary

of Chakrapanidatta.2011 reprint ed. Varanasi: Chaukamba Orientalia; 2011. p.79/80.

27. Sri Rajeshwara data shastry ayurvedashastra acharya. (ed). Bhaishajyaratnavali of

Bhishagratna Shri Brahmashankaramishra revised by Govindadas with Vidyothini hindi

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Dharmananda shastry, 11th ed. New Delhi: Motilal Banarasi das; 1979.P.376-377.

29. Ayurvedacharya Sri Y T Acharya.(ed). Rasaratna Samuchhaya with Vijnana Bhodhini

Hindi Commentary by Prof. Dattatreya Ananta Kulkarni, Vol I, Reprint – 1998. New Delhi:

Meharchand Lachhamandas Publication; P.97.









Meharchand Lachhamandas Publication; P.74-75.

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Rasavijnana hindi commentary by Ayurvedacharya Sri haridattashastry with Ayurvedacharya Pa.

Dharmananda shastry, 11th ed. New Delhi: Motilal Banarasi das; 1979.P.614-615.

34. Potter, S.O.L. (1984). A compend of material medica, therapeutics, and

prescription writing, with especial reference to the physiological actions of drugs. 6th

edition, 1902. Philadelphia: P. Blakiston’s sons & Co.

35. Eichhorst, H. (1986). Handbook of Practical medicine. Volume I. Diseases of

Circulatory and Respiratory apparatus. New York: William Wood and Company.

36. Leake, C.D.(1975). An historical account of Pharmacology to the twentieth

century. Springfield, IL: Charles C. Thomas.

37. Garber, S. T.(1942). Stedman’s Practical medical dictionary. Baltimore: Williams

& Wilkins.

38. Fomon, S.(1920), Medicine and the allied sciences. Volume III. Newyork: D. Appleton

and company.

39. Keelay, L. E.(1897). Opium: its use, abuse and cure. Chicago, IL: The Banner of Gold,

Co.[Reprint New York: Arno Press; 1981].

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43. Acharya J T, Narayan Ram Acharya Kavya Tirtha. (ed). Susruta Samhita with Nibandha

Sangraha Commentary of Dalhana. 6th ed. Varanasi: Chaukambha orientalia; 1997.P.144.

44. Acharya J T, Narayan Ram Acharya Kavya Tirtha. (ed). Susruta Samhita with Nibandha

Sangraha Commentary of Dalhana. 6th ed. Varanasi: Chaukambha orientalia; 1997.P.266

45. Acharya J T, Narayan Ram Acharya Kavya Tirtha . (ed). Susruta Samhita with Nibandha

Sangraha Commentary of Dalhana. 6th ed. Varanasi: Chaukambha orientalia; 1997.P.427-428.

46. Bhisagacharya Harisastri Paradakara Vaidya.(ed). Astangahrudayam with commentary

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by Sarvangasundara of Arunadatta and Ayurvedarasayana of Hemadri, 9th ed. Varanasi:

Chaukambha orientalia; 2005.p.725.

48. Sheeja.G, Kottakkal (2008)- A Study on Post Stroke Depression And Its Managment

With Brahmi Taila Nasyam & Psychotherapy.

49. Benjamin J. Sadock & Virginia A. Sadock. (ed). Kaplan & Sadock’s Comprehensive text

book of Psychiatry – Vol I, 8th ed. New York: Lippincott Williams & Wilkins; p. 349-361.

9. SIGNATURE OF THE CANDIDATE :

10. REMARK OF THE GUIDE :

11. NAME AND DESIGNATION OF

11.1. GUIDE : Dr. NARAYAN PRAKASH B.

M.D.(Ayu), Ph.D

PROFESSOR AND H.O.D.

DEPT. Of MANASA ROGA

SDMCA & H, HASSAN.

11.2. SIGNATURE AND SEAL :

11.3 REMARKS OF THE CO-GUIDE :

11.4 CO-GUIDE : Dr. RAVISHANKAR B

M.Sc, Ph.D

DIRECTOR

SDM RESEARCH CENTRE FOR

AYURVEDA AND ALLIED SCIENCES,

UDUPI

11.5 SIGNATURE AND SEAL :

11.6. HEAD OF THE DEPARTMENT : Dr. NARAYAN PRAKASH B.

M.D.(Ayu), Ph.D

PROFESSOR AND H.O.D.

DEPT. Of MANASA ROGA

SDMCA & H, HASSAN.


12.1. REMARK OF CHAIRMAN AND

PRINCIPAL :

12.2. PRINCIPAL : DR. PRASANNA. N. RAO. M. S. (AYU), Ph.D.

S.D.M.COLLEGE OF AYURVEDA AND

HOSPITAL, HASSAN – 573 201.


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