Rajiv Gandhi University of Health Sciences s182

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

“A COMPARATIVE CLINICAL EVALUATION OF VISHNUKRANTHYADI KASHAYAM WITH AND WITHOUT KSHEERABALA TAILA SHIRO PICHU IN THE MANAGEMENT OF ANIDRA W. S. R TO PRIMARY INSOMNIA” BY DR. DILEEP K. S

B.A.M.S GUIDE DR. DEBAJIT BHATTACHARRYA MD (Ayu), FAGE. PROFESSOR

CO-GUIDE DR. NIRANJAN Y MD (Ayu), Ph.D Scholar. LECTURER

DEPT. OF P.G. STUDIES IN KAYACHIKITSA A.L.N.RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE AND P.G. CENTRE KOPPA – 577126

2011-2012

1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE. ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate : DR. DILEEP K. S And Address PG.DEPT. OF KAYACHIKITSA A.L.N. RAO MEMORIAL AYURVEDIC MEDICAL COLLEGE AND P.G CENTRE KOPPA, CHIKMAGALUR (DIST) KARNATAKA - 577126.

2. Permanent address : DR. DILEEP K. S S/O SANKARAN. K KARUMALY HOUSE MUPLIYAM P. O THRISSUR DISTRICT, PIN-680312 KERALA STATE

3. Course of study : AYURVEDA VACHASPATHI and subject: MD (AYU.), KAYACHIKITSA

4. Date of admission : 2ND NOVEMBER 2011 of course 5. Title of the topic : “A COMPARATIVE CLINICAL EVALUATION OF VISHNUKRANTHYADI KASHAYAM WITH AND WITHOUT KSHEERABALA TAILA SHIRO PICHU IN THE MANAGEMENT OF ANIDRA W. S. R TO PRIMARY INSOMNIA”.

2 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 Need for the study:

Insomnia is inability to sleep, in the absence of external impediments, such as noise, a bright light, etc., during the period when sleep should normally occur; may vary in degree from restlessness or disturbed slumber to a curtailment of the normal length of sleep or to absolute wakefulness1. A general consensus has developed from population-based studies that approximately 30% of a variety of adult samples drawn from different countries report one or more of the symptoms of insomnia.

Sleep disorders are very common medical problems of millions of people. It may not be known to many but millions of people suffer from various sleep problems that not only affect their physical and mental capacity, but their emotional and social behavior as well. The persistent stress and strain of various spheres of life adversely affect the health of the individual. Hence maintaining good quality of sleep would be crucial to health.

Ayurveda has described nidra among the primary tripod of life 2(Ahara, Nidra & Brahmacharya). Each of these deserves due importance because these factors are concerned with the basic needs of living system and over indulgence or total abstinence of any of these may be harmful to life. Charaka has described Anidra as one of the vataja naanaathmaja vikara2. Nidra nasa is mainly caused by vata dosha or pitta dosha or due to manastaapa, sosha or abhigata3. Stress is one of the commonest causes attributed to insomnia and also one who suffers from insomnia may later develop chronic psycho-physiological insomnia as a result of initial stress.

For the treatment of insomnia various types of tranquilizers are being used by the modern doctors. Constant use of tranquilizers and similar drugs for a long time induced various side effects and drug dependence in people. In ayurvedic classics there are a number of herbal and herbo-mineral compounds for the management of Anidra. Although a number of research works have been done on the management of Anidra, still more formulations should be tried for the effective management of the disease. Therefore a formulation namely “Vishnukranthydi kashayam”4 mentioned in Chikitsa Manjari4 has been selected for this present study along with

5 6 5 “Ksheerabala Taila” Shiro Pichu mentioned in Sahasrayogam in one group and without shiro pichu in other group. Vishnukranthyadi kashayam which includes vishnukrantha (evolvulus

3 alsenoides) and shunti, along with ksheera as anupana has been referred as Nidrakara. Ksheerabala taila which includes bala and ksheera are having vata pittahara property. This combination has been selected with the research hypothesis to revalidate its efficacy in the management of Anidra (primary insomnia).

6.2 Review of literature:

All the Ayurvedic classical literatures including Brihatrayi, Laghutrayi and the text books related to dravyaguna vijnana will be reviewed for the study. Present time journals including websites and contemporary medical books also will be referred for the study.

1. Charaka samhita2 2. Susruta samhita3 3. Ashtanga sangraha7 4. Ashtanga hridaya6 5. Chikitsa manjari4 6. Sahasra yogam5 7. Kasyapa samhitha8 8. Harison’s principles of internal medicine9 9. Davidson’s principles and practice of medicine10

Previous works done:

1. U. D Joshi 1987- study on Anidra- An etiopathological and management approach, I. P. G. T & R. A, Jamnagar.

2. Mishra P.K 1991- A clinical study of shirodhara on insomnia I.P.G.E. & R.A, University of Kolkata.

3. Kavitha trivedi 1995-Comparative study of shirodara and shiro basti in the management of Anidra. I. P. G. T & R. A, Jannagar.

4. Ramakant yadav 1995- Clinical and Experimental of Anidra and effect of Medhya Rasayana, Faculty of Ayurveda, IMS BHU.

4 6.3 Objectives of study: 1. To carryout comprehensive literary work covering Ayurvedic classics and contemporary system of medicine on Anidra (primary insomnia). 2. To evaluate the efficacy of Vishnukranthyadi kashayam in the management of Anidra (primary insomnia). 3. To evaluate the comprehensive effect of Vishnukranthyadi kashayam and Ksheerabala Taila Shiro Pichu in the management of Anidra (primary insomnia). 4. To compare the effect of Vishnukranthyadi kashayam with and without Ksheerabala Taila Shiropichu on Anidra (primary insomnia).

7. MATERIAL AND METHODS 7.1 Source of data: a. Literary source: A complete review of all the classical literatures, bearing the description related to the disease Anidra (primary insomnia) shall be made, so as to obtain theoretical data for the present study, also review of all the relevant literatures shall be made to obtain references related to the formulation w. r. t. their preparation and dosage etc., required for the study. b. Pharmaceutical source: The formulation Vishnukranthyadi kashayam and Ksheerabala Taila selected for the present research work shall be prepared in the pharmacy attached to A.L.N.Rao Memorial Ayurveda Medical College, Koppa as per the textual reference. c. Clinical source: Patient of either sex attending the OPD & IPD of A.L.N.Rao Memorial Ayurveda Medical College & Hospital Koppa or its associated hospitals will be selected for the study.

5 7.2 Method of collection of data For the present study 40 patients of either sex of age group 20-60 yrs will be selected. The patients will be selected strictly abiding to the inclusion and exclusion criteria. The patients thus selected will be randomly grouped in to two groups of size each 20. The first group will be administered Vishnukranthyadi kashayam 25 ml twice daily before food and the duration of treatment will be for 30 days. The second group will be administered Vishnukranthyadi kashayam same as in first group with Ksheerabala Taila Shiro Pichu for 7 days. Shiropichu will be done in the evening hours for 20-25 minutes. The general condition of the patient will be thoroughly assessed through the subjective criteria. The detailed history and examnation findings will be noted before, during and after the scheduled treatment and the changes in symptoms will be documented in a specially designed case proforma. The symptoms will be assessed before, during, and after the scheduled treatment with an interval of 15 days. Scoring will be given for subjective and objective parameters. Study Design: single blind randomized comparative clinical study design will be adopted.

Criteria for selection of patient:- Inclusion criteria:

1. Patients of either sex with age group 20-60 years.

2. Primary insomnia diagnosed on the basis of DSM-IV-TR Diagnostic criteria11.

Exclusion criteria:

1. Psychiatric patients on treatment

2. Drug induced insomnia.

3. Patients who are already on treatment for insomnia.

4. Secondary insomnia.

5. Pregnant and lactating women.

6 Treatment schedule: Group-1 Sample size 20 Medicine Vishnukranthyadi kashayam Dose 25ml twice daily before food Anupana Govksheera equal quantity Total Duration 30 days

Group-2

Sample size 20 Medicine Vishnukranthyadi kashayam Ksheerabala taila Shiropichu orally Dose 25ml twice daily before food q.s Anupana Govksheera equal quantity - Total Duration 30 days 7 days

NOTE:  Post treatment follow up study will be undertaken for 30 days.  During the period of study the patients will be advised to follow Pathyapathya.

Assessment of response: Subjective parameters:

The subjective parameters include the following points like sleeplessness, sleep-wake schedule, sleep quality, sleep time and day time fatigue or sleepiness. The associated symptoms like akshigaurava and shirogaurava also will be assessed6. For the assessment, scoring will be given to all the symptoms according to severity and will be documented properly before and after the

7 treatment.

Objective parameters: The objective parameters will be assessed on the basis of Athens Insomnia scale12. The evaluation will be done on the basis of result obtained from statistical analysis by student ‘t’ test.

7.3 Does the study require any investigations or interventions to be conducted on patient or humans or animals? If so please describe briefly. YES, the study will be a clinical study.

Investigations: 1. Blood for Hb%, TLC, DLC, ESR 2. Urine for sugar, albumin and microscopic.

Intervention: Group-1

Sample size 20 Medicine Vishnukranthyadi kashayam Dose 25ml twice daily before food Anupana Govksheera equal quantity Total Duration 30 days

Group-2

Sample size 20 Medicine Vishnukranthyadi kashayam Ksheerabala taila Shiropichu orally Dose 25ml twice daily before food q.s

8 Anupana Govksheera equal quantity - Total Duration 30 days 7 days

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

9 8. REFERENCES:

1. Thomus Lathrop Stedman, Stedman’s medical dictionary, 25th edition, USA, Williams & Wilkins, 1990, p. 788. 2. Acharya Agnivesa , Charaka samhitha, sutra sthana, English translation by R. K Sharma & Bhagavan Dash, 6th edition, Varanasi, chowkhambha sansrit series office, 1997, ch-11 & 20, p. 219 & 363. 3. Acharya Susrutha, Susrutha samhitha, sareera sthana, English translation by prof. K. R Srikantha murthy, Varanasi, chowkhambha orientalia, 2004, ch-4, p. 65-66. 4. D. Sreeman Namboothiri, Chikitsa Manjari, mantha nidra chikitsa, 8th edition, alapuzha, vidyarambham publishers, 2008, p. 419-420. 5. Sahasryoga, Sanskrit hindi anuvad, kendreeya ayurveda and sidha anusandhana parishad, new delhi, 1990, taila yoga-124, p. 292. 6. Acharya Vagbhata, Ashtanga hridayam, sutra sthana, vdyotini hindi commentary by Kaviraja Atrideva Gupta, edited by vaidya yadunandana upadhyaya, Varanasi, choukhambha sansrit sansthan, 2005, ch-7 & 22, p. 72 & 134. 7. Acharya Vagbhata, Ashtanga sangraha, sutra sthana, English translation by Prof. K. R. Srikantha murthy, 6th edition, Varanasi, chaukhambha orientalia, 2002, p. 203-209. 8. Acharya Kasyapa, Kasyapa samhitha, khila sthana, English translation by P. V Tewari, Varanasi, choukhambha visvabharati, 2008, ch-5, p. 485. 9. Fauci AS, Braunwald E, Kasper DL, Hauser SL, Longo DL, Jameson JL, et al., editors. Harrison’s principles of internal medicine. 17th ed. New York: McGraw Hill; 2008, section-3, ch-28, sleep disorders, p. 171. 10. Davidson’s principles and practice of medicine, 21st edition Churchill livingstone, 2010, medical psychiatry, ch-10, p. 229. 11. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). American psychiatry association, Washington DC. 12. Based on ICD-10 criteria, Sleep Research Unit, Department of Psychiatry, Athens

10 University Medical School, Athens, Greece.

9. Signature of the Candidate :

10. Remarks of the Guide :

11. Names and Designation of (In BLOCK Letters) 11.1. Guide : DR. DEBAJIT BHATTACHARYYA

(In BLOCK Letters) MD (Ayu), FAGE. PROFESSOR

11.2. Signature :

11.3. Co-Guide (If Any) : DR. NIRANJAN Y. ` MD (Ayu), Ph.D Scholar. LECTURER 11.4. Signature :

11.5. Head of Department : DR. DEBAJIT BHATTACHARYYA

M.D (Ayu) FAGE PROFESSOR 11.6. Signature :

12 12.1. Remarks of Dean/Principal :

11 12.2. Signature :