Clinical Management of Migraine

(A) VI. Brief resume of the intended work

6.1 Need for the study Ayurveda, the science of life is not merely a system of medicine. Even before the W.H.O. gave the definition of health, Ayurveda had clearly indicated that good health involves physical, mental, social and spiritual well being. Ayurveda not only explains various diseases with treatment but also explains to maintain the good health by following Dinacharya, Ritucharya and Sadvrittas.

With the evolution of civilization man has become more and more physically inactive. Now a days the codes and conducts narrated in the ancient texts of Ayurveda are ignored. Modernization, affluence, science and technological development lead to still more sedentary life styles. By exposing oneself to all these factors human beings unknowingly invited a number of diseases, out of which Sthoulya is one which disturbs physical, mental as well as social health of an individual.

Sthoulya is the abnormal & excess accumulation of Medodhatu. Frequent and/or excess intake of Kapha increasing foods, sedentary lifestyle, Lack of mental & physical exercise are the most common etiological factors. Sthoulya can also occur due to beeja dosha i.e. hereditary causes.

In modern medical science Sthoulya is compared with Obesity. Obesity is defined as excess of body fat that poses a health risk. It is caused by excess calorie intake, endocrine disorders like Hypothalamic disorders, Hypothyroidism, Cushing’s syndrome etc. Obesity can also be drug induced or due to genetic inheritance.

According to the surveys, Obesity has reached epidemic proportions in India in the 21st century, affecting about 120 million of the country's urban population. India ranks amongst the top ten obese nations. As compared to normal individuals, obese persons are 17 times more prone for backache and knee pain, 8 times more prone to get fatty liver, 5 times for diabetes, 4 times for hypertension and 2 times more prone to get breast cancer, cancer of uterus and infertility. According to the 2002 W.H.O. report, obesity is ranked one amongst the top 10 selected health risk and total health care expenditure for obese patients is 2-8%.

These statistical datas on the prevalence of Obesity clearly show that there is an urgent need of a wake up call for global community to curb the health risks, mortality rates, and economic costs associated with this disease. For treatment of Sthoulya, the ancient Ayurvedic texts advice regular exercise, langhana (fasting), body purification by panchkarma procedures like lekhan and rookshana bastis. Many medohara, lekhana and karshana dravyas like Shilajitu, Gomootra, Madhu, Musta etc are also told. It is also said that treatment of Sthoulya is not easy, but with proper selection and combination of drugs and panchkarma procedures, it can be managed.

In present study Basti procedures especially Lekhana Basti and Kshara Basti along with Trayushanaadi Loha as mentioned in ayurvedic texts will be used to access their efficacy in patients of Sthoulya (Obesity).

In Allopathy also the stress is given upon calorie restriction in diet, regular exercise and drugs acting as appetite suppressants. These drugs act centrally and their regular use is most of the times associated with adverse effects like dryness of mouth, constipation, diarrhea, menstrual disorders, rhinitis, migraine etc.

Keeping all the above points in mind, this topic is selected for the study and an atempt has been made to find an Ayurvedic treatment which is effective, without side effects, economic, and easily available to all.

6.2. Review of Literature:

1. Explanation of Sthoulya 1 , 2, 3 2. Explanation of Obesity.4,5, 6 3. Trayushanadi loha as shamana aushadhi 7 4. Lekhana basti 8 5. Kshara basti 9 6. Procedure of basti karma10

Previous Works done on Sthoulya:

1. Satyavati G.V. - Effect of an indigenous drug on lipid metabolism w.r.t. Obesity and Atherosclerosis, Faculty of Ayurveda, I.M.S., Banaras Hindu University, Varanasi, 1966.

2. Swami N.K. – Sthoulya roga ke paripekshya me lekhan vati evam lekhan basti ka chikitsaatmaka adhyana, N.I.A. Jaipur, Rajasthan University, Rajasthan, 1997. 3. Tyagi Vudushi - A study on Amritaadi Guggulu w.s.r. to Sthoulya adhikara, Rishikula State Ayurvedic College, Haridwar, Kanpur University, 1999.

4. Kerur Prasanna –A clinical study on Sthoulya(Obesity) w.s.r. to its management through Lekhana Basti and Amritadi Guggulu, HASS’s Ayurveda Mahavidyalaya, Hubli, Rajiv Gandhi University Of Health Sciences, Banglore,1999.

5. Gepam P. – A study on interrelationship between Medoroga (Obesity) and Prameha, Faculty of Ayurveda, I.M.S., Banaras Hindu University, Varanasi, 2000.

6. Sankh Kuber S. –Efficacy of bilva patra swarasa in Sthoulya –A Clinical study, Government Ayurvedic College, Banglore, Rajiv Gandhi University Of Health Sciences, Banglore, 2000.

7. Meena R.R. – Medo agni vikriti janya Sthoulya roga ke pariprekshya me lekhneeya mahakashaya ka prabhaavaatmak adhyana, N.I.A. Jaipur , Rajasthan University, Rajasthan, 2001.

8. Binu K.S.- A critical study on Udvartana w.s.r. to Sthoulya (Obesity), Government Ayurvedic College,Trivendrum,Kerela University, Thiruvananthpuram, 2001.

9. Prassana Kumar – Effect of Udvartana on Sthoulya, S.D.M. College of Ayurveda, Hassan, Rajiv Gandhi University Of Health Sciences, 2001.

10. Velhal A.R. – Study of luke warm water (koshna jala) on obesity, Tilak Ayurveda Mahavidyalaya, Pune University, Pune, 2002.

11. Dr. I.S. Mathapati – A clinical study on the management of Hypercholestraemia with reffrence to lekhana basti and Dashang Guggulu, HASS’s Ayurveda Mahavidyalaya, Hubli, Rajiv Gandhi University Of Health Sciences, 2002.

6.3 Objectives of the study

1. To study about Sthoulya vis a vis Obesity In Ayurvedic and Modern literature. 2. To evaluate the role of Lekhana Basti in Sthoulya (Obesity). 3. To evaluate the role of Kshara Basti in Sthoulya (Obesity). 4. To evaluate the role of Trayushanadi Loha in Sthoulya (Obesity). 5. To evolve a comprehensive remedy for Sthoulya (Obesity). (B)VII. Materials and Methods

7.1 Source of Data

In the present study, the patients attending the O.P.D. and I.P.D. of Post Graduate Department of Kayachikitsa, Ayurveda Mahavidyalaya Hospital, Hubli, will be selected for the study.

7.2 Methods of collection of Data

a. A clinical survey of patients attending the OPD and IPD of Post Graduate Department of Kayachikitsa, Ayurveda Mahavidyalaya Hospital, Hubli will be made and patients fulfilling the criteria of diagnosis as per the Performa will be selected for the study. b. Clinical evaluation of patients will be done by collection of data through information obtained by history, physical examination, and laboratory tests. c. Review of literature will be collected from Post Graduate Library, Department of Kayachikitsa, Ayurveda Mahavidyalaya, Hubli, and from Authentic Research Journals, Websites, Digital Publications etc d. The data, which are obtained by the clinical trial will be statistically analyzed by applying Student’s‘t’ test.

Inclusion Criteria

1. Subjects presenting with classical features of Sthoulya as per Ayurvedic texts.

2. Subjects having B.M.I. greater than or equal to 30 in males and 28.6 in females. 3. Subjects of either sex between the age group of 18-60 years. 4. Subjects fit for Basti karma. Exclusion Criteria

1. Subjects not fulfilling the inclusion criteria.

2. Subjects having associated complications like cardiac diseases. 3. Subjects having Sthoulya due to endocrine or genetic abnormalities. 4. Subjects having fissure, fistula and hemorrhoids.

Parameters of Study:

Subjective Parameters: 1. Ati kshudha. 2. Ati pipasa. 3. Ati sweda 4. Ati nidra. 5. kshudra shwasa / Alpa shwasa 6. Alasya / Utsaha haani 7. Daurbalya / Alpa vyayama 8. Daurgandhya.

Objective Parameters:

Objective parameters will be based on the changes in:

1.ChalaSphigaUdaraStana. 2. Body Mass Index (B.M.I.). 3. Waist Hip Ratio. 4. Lipid profile.

Study Design: Clinical study Sample size: A total of 30 subjects diagnosed with Sthoulya will be selected and they will be randomly divided in three groups with 10 patients in each group.

Group – A: 1. Ampachana with Panchakola choorna 2. Snehana and swedana as poorvakarma of basti. 3. Lekhana basti 4. Trayushanadi Loha as shamana aushadhi

Group – B:

1. Ampachana with Panchakola choorna 2. Snehana and swedana as poorvakarma of basti. 3. Kshara basti. 4. Trayushanadi Loha as shaamana aushadhi

Group –C: Placebo

Assessment criteria

Marked relief -Above 75% Moderate relief -50%-75% Mild relief - 25%-50% No relief - Below 25% 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.

Investigations 1. Lipid profile including -HDL - LDL - TOTAL CHOLESTEROL - SERUM TRIGLYCERIDES 2. Other investigations to rule out any endocrine or metabolic pathology (if necessary). 3. Routine blood and urine investigation. 4. E.C.G.

Interventions:

Group – A:

1. Ama pachana with Panchakola Choorna 5-10 gms twice daily with hot water half an hour before food for 3-5 days.

2. Sthanika Abhyanga and Nadi Sweda as poorvakarma of Basti.

3. Lekhana basti in yoga basti schedule.

4. Trayushanadi loha 500 mg. bid with honey

DURATION - ONE MONTH

FOLLOW UP - TWO MONTHS Group – B:

1. Ama pachana with Panchakola Choorna 5-10 gms 2-3 times daily with hot water half an hour before food for 5-7 days.

2. Sthanika Abhyanga and Nadi Sweda as poorvakarma of Basti

3. Kshara basti in yoga basti schedule.

4. Trayushanadi loha 500 mg bid with honey

FOLLOW UP - TWO MONTHS

Group –C:

Placebo Capsules filled by Jowar Flour -1 cap. Bid with Luke warm water

FOLLOW UP - TWO MONTHS

7.4 Has ethical clearance been obtained from your institution in case of 7.3

Ethical clearance has been obtained by the ethical committee constituted by AYURVEDA MAHA VIDYALAYA, 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) List of References:

1. Agnivesha, Charaka Samhita(poorvaardha) with Charaka Chandrika hindi vyakhya by Dr. Bhramananda Tripathi, Chaukhamba Surabharti Publications, Varanasi, reprint, page no.399, Pp 1052, 2002

2. Sushruta Samhita, Hindi vyakaya by Atrideva, Motilal Banarsidas Publications, Delhi, 5th edition, Reprint, Page No.-60, Pp-812, 2002.

3. Shrimad Vagbhat aacharya krit Astanga Sangrah Sutra sthana, Saroj Hindi vyakhya by Dr. Ravidatta Tripathi, published by Chaukhamba Sanskrit Pratishthana,Delhi, reprint edition, Page No. 437, Pp-683, 2001.

4. Sir Stanly Davidson, Davidson’s Principals And Practice of Medicine, Churchill Livingstone, Newyork, 17th edition, Page No. 578-585, Pp-1203.1995.

5. Jeffery S. Flier, Harrison’s Principals Of Internal Medicine Vol.-1, Mc Graw Hill, New York, 15th edition, Page No. 479, Pp – 1442..

6. A.P.I. Textbook of Medicine, edited by G.S. Sainani, Published by Association of physicians of India, Mumbai, 6th edition, Page No. 208, Pp – 1444, 1991.

7. Kaviraja Ambikadatta Shastri, Bhaishjya Ratnavali,edited by shri Rajeswar Datta Shastri, Chaukhamba Sanskrit Sansthana, Varanasi, 13th edition, page no. 525, Pp-891.

8. Sushruta Samhita, Hindi vyakaya by Atrideva, Motilal Banarsidas Publications, Delhi, 5th edition, Reprint, Page No 545, Pp 812 , 2002

9. Chakrapanidatta, Chakradatta, edited by P.V. Sharma, Chaukhamba Publications, Varanasi, 2nd edition, page no. 628, Pp-731, 1998

10. Vaidya H. S. Kasture, Ayurvediya Panchakarma Vigyan, Baidyanath Ayurved Bhavan, 6th edition, page no-371-484, Pp-712, 1999