Clinical Management of Migraine

[A] VI. Brief resume of the intended work

6.1 Need for the study

Ayurveda is a holistic science deals with the Psychological, physiological and pathological aspect of human life. It gives the idea about how to maintain the homeostasis of life. In any other system of medicine there is no procedure for eradicating the disease from the roots. Only Ayurveda is such a system of medicine where the importance of both prevention and cure are highlighted. As per Ayurvedic texts diseases are deep seated at different dhatu levels. Hence a procedure should be there to uproot the deep seated disease. The importance of Panchakarma lies in the fact that it helps in uprooting the disease and bringing the vitiated doshas to their normalcy. The preference of knowing the manifestation of a disease at every level is utmost importance in controlling the disease.

In ancient classics Acharyas clearly mentioned about the disease Ardita under the classification of Vata vyadhi. Due to various nidana vata gets vitiated and settles down in the region of forehead, nose, chin, ears, eyes and leads to the disease condition called Ardita. Netra stabdata, Mukha vakrata, Lalata vali nasha, Danta chala, Swarabhramsa, Sruti hani, Parswa nishteevadha, Karna vedana and Gandha jnana nasham are all the common presenting features of Ardita. According to Acharya Sushruta ‘Mukha Matra Eva Ardita’ ie; the disease affects only in the face is called Ardita.

As per Modern science Idiopathic facial palsy or Bell’s palsy occur due to the dysfunction of the 7th cranial nerve results inability to control the facial muscles .The clinical features of bell’s palsy like; absence of furrowing on the forehead, inability to close the ipsilateral eye (Bell’s phenomenon), Hyperacusis, Articulation is at first indistinct, fluids are spilled during drinking and food collects between the cheek and the gum etc are having similarity with the clinical features of Ardita.

Several conditions like Stroke, Lyme disease, Zoster virus, environmental and metabolic factors can leads to Bells’palsy. In lower motor neuron lesions symptoms starts suddenly and all are mostly unilateral and may vary to mild to severe.

According to statistical data, the incidence is 25 per 1,00,000 annually. It affects men and women equally and is seen at all ages. Incidence is probably higher in diabetics and pregnancy.

There is no satisfactory treatment in Modern science steroid like Prednisolone, Antiviral like Valaciclovir may use full in certain conditions; decompression surgery yet to prove the result. It may lead to the complication like; loss of taste, spasm of muscles, eye lids, 6% of the patients have Gusto- lacrimal reflexe and Facial synkinesis.

In Ayurveda all the classics are mentioned about the different treatment modalities of Ardita ie; Sirobasti,Tarapana, Abhaynga, Nasya, Snehapana. Nasya karma is therapeutic procedure in which the drug administered through the Nasa to eliminate the aggravated doshas situated in Urdhajatru.

In Ayurveda it’s mentioned that ‘Nasa Hi Shiraso Dwaram’, so Nasya is the one of the procedure in which the medicines administered are directly acting on the head and protecting all the sense organs. Nasya is the therapy in which the effect will vary according the drug which is used for the procedure. For eg: Shamana nasya, Shodhana nasya etc. In the disease Ardita, Prana, Udana and Vyana Vata getting vitiated and settles in Shiras, so for the management of Ardita, Nasya is considered to be the best method.

Considering all these factors and plight of patients with Ardita it is planned to under take the disease and manage with Navana Nasya karma. In the present comparative clinical study Karpasasthyadi Taila and Prasarinyadi Taila are selected for Navana Nasya Karma. Initially one course of Navana Nasya Karma for 7 days with respective Taila will be given in both the groups, followed by 14 days of Parihara Kala. Looking into Severity, Samprapti ghatakas involved in Ardita Vata, it is planned here to give one more course of Navana Nasya after completion of Parihara kala of First course, followed by 14 days of Parihara Kala. During the second course of Parihara Kala, internally Vidaryadi Kashayam along with Ekangaveera Rasa will be given as Shamanoushadhi in both the groups for 21 days. The efficacy of the Navana Nasya will be evaluated in both the groups and the comparative efficacy also will be evaluated.

6.2. Review of Literature:

1. Explaination of Ardita.1,2

2. Management of Ardita.3,4

3. Explanation of Bell’s palsy.5,6,7

4. Management of Bell’s palsy.5,6,7

5. Explanation of Nasya.8

6. Procedure of Nasya.8

7. Prasarinyadi Taila.9

8. Karpasathyadi Taila.10

9. Vidaryadi Kashayam.11

10. Ekangaveera Rasa.12

Previous Works done:

1. Vivekananda K. – The Clinical management of Ardita Vata with Bhunag-Taila Nasya along with Ekangaveera Rasa (internally). DR B.K.R.R Government Ayurvedic College, Hyderabad, A.P University, Vijayawada, 1997.

2. Laxman P. H. –The clinical study of the effect of Vata Gajankush Rasa (internally) and Anu Taila Nasya in Ardita Vata. DR B.K.R.R Government Ayurvedic College, Hyderabad, A.P University, Vijayawada, 1998.

3. Venkatesh R – Role of Nasya Karma in Ardita w.s.r to Ksheer Bala Taila. S D G M Ayurvedic Medical College, Gadag, Rajiv Gandhi University Of Health Sciences, Banglore, 1999.

4. Asha S. I. – A clinical study to evaluate the effect of Nasya in the management of Ardita w.s.r to Bell`s palsy. Govt. Ayurvedic Medical College Mysore, Rajiv Gandhi University of Health Sciences, Banglore, 2003.

5. Supekar M.V. – Ardita Vyadhi (Facial Paralysis) mein Mashadi Nasya: Ek Adhyana. Shri Ayurveda Mahavidyalaya Nagpur, Nagpur University, 2003.

6. Prashant C.S. – Clinical study on the effect of Mahamashadi Taila Nasya Karma in Ardita (Upper motor neuron lesion palsy). S.D.M college of ayurveda Udupi, Rajiv Gandhi University Of Health Sciences, Banglore, 2003.

7. Nitin B Tatpuje – A Clinical Study on Ardita Roga with special reference to Navana Nasya and Shiro Pichu. HASS’s Ayurveda Mahavidyalaya Hubli, Rajiv Gandhi University of Health Sciences, Banglore, 2003.

8. Anil Gupta - Clinical management of Ardita (facial palsy) through Nasya and Shirobasti. HASS’s Ayurveda Mahavidyalaya Hubli, Rajiv Gandhi University of Health Sciences, Banglore, 2003.

6.3 Objectives of the study

1. To study Nasya Karma in detail.

2. To study Ardita according to Ayurvedic text and Bell’s palsy in Modern medicine in detail.

3. To assess the efficacy of Nasya Karma with Karpasasthyadi Taila in the management of Ardita (Bell’s Palsy).

4. To assess the efficacy of Nasya Karma with Prasarinyadi Taila in the management of Ardita (Bell’s Palsy).

5. To compare the efficacy of Karpasasthyadi Taila Nasya and Prasarinyadi Taila Nasya in the management of Ardita (Bell’s Palsy).

[B] VII. Materials and Methods

The present study titled Comparative Clinical Study to Evaluate the Efficacy of Navana Nasya with Karpasasthyadi Taila and Prasarinyadi Taila in the Management of Ardita W.S.R to Bell’s Palsy, is a clinical trial which will be done with following materials;

§ Karpasasthyadi Taila

§ Prasarinyadi Taila

§ Vidaryadi Kashayam

§ Ekangaveera Rasa

7.1 Source of Data

In the present study, the research scholar proposes to take the subjects attending the Outpatient Wing an inpatient wing of Post Graduate Department of Panchakarma, Ayurveda Mahavidyalaya Hospital, Hubli.

7.2 Methods of collection of Data

a. A clinical survey of subjects attending the OPD and IPD of Post Graduate Department of Panchakarma, Ayurveda Mahavidyalaya Hospital, Hubli will be made and subjects fulfilling the criteria of diagnosis as per the proforma will be selected for the study.

b. A clinical evaluation of patients will be done by collection of data through information obtained by history, physical examination, and laboratory tests including radiography.

c. Review of literature will be collected from Post Graduate Library, Department of Panchakarma, Ayurveda Mahavidyalaya, Hubli, and from Authentic Research Journals, Websites and Digital Publications etc.

d. 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.

e. The data which are obtained by the clinical trial will be statistically analyzed by applying Student ‘t’ test.

Inclusion Criteria

1. Subjects with classical features of Ardita roga explained in classical texts.

2. Subjects with clinical features of Bell’s palsy.

3. Subjects from either sex will be selected in the age group of 15-65 years.

4. Subjects with chronicity less than one year.

5. Subjects who are fit for Nasya Karma.

Exclusion Criteria

1. Subjects with uncontrolled metabolic disorders and other systemic disorders.

2. Subjects with HIV and HBsAg +ve

3. Subjects with degenerative disorders of brain.

4. Subjects with Intra cranial infectious disease.

5. Subjects who are not fit for Nasya Karma.

6. Ardita lakshanas along with Pakshaghata Vyadhi.

Parameters of Study:

Subjective Parameters:

A- On disease

1) Mukha Parshwa Greeva Vedana

2) Vak Sangha

3) Karna Vedana

B- On procedure

1) Laghuta of Siras

2) Sukha Swapna

3) Indriya Visudhi

4) Siro Guruta (If present)

5) Vibhrama

Objective Parameters:

A- On disease

1) Mukha Vakrata

2) Akshi Nimesh Asamarthya

3) Lalata Vali Nasha.

4) Lala Srava

B- On procedure

1) Blood pressure before and after Nasya Karma.

2) Pulse before and after Nasya.Karma.

3) Temperature of Nasya Dravya before administration.

4) Kshudha Pravruti, Mala Pravruti etc. on the day of Nasya Karma.

5) Dose (Matra) of the Dravya used in Nasya Karma.

Study Design: A Comparative Clinical Study.

Sample size: A Minimum of 30 subjects diagnosed as Ardita will be selected incidentally and randomly categorized into two groups consisting 15 subjects in each group

Group – A:

o Navana Nasya with Karpasasthyadi Taila for 7 days initially followed by 14 days of Parihara Kala. Then one more course of Navana Nasya with the same Taila for 7 days after which 14 days of Parihara Kala will be followed again.

o During second course of Parihara Kala internally Ekangaveera Rasa with Vidaryadi Kashaya as Anupana will be given as Shamanoushadhi for 21 days.

Group – B:

o Navana Nasya with Prasarinyadi Taila for 7 days initially followed by 14 days of Parihara Kala. Then one more course of Navana Nasya with the same Taila for 7 days after which 14 days of Parihara Kala will be followed again.

o During second course of Parihara Kala internally Ekangaveera Rasa with Vidaryadi Kashaya as Anupana will be given as Shamanoushadhi for 21 days.

Duration: 49 days.

Follow Up: 1 month.

Assessment criteria:

Change in Subjective and objective features of Ardita before and after the treatment. The result will be recorded as;

Marked relief - Above 75% Improvement

Moderate relief - 50%-75% Improvement

Mild relief - 25%-50% Improvement

Unchanged - Below 25% Improvement

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.

YES

Investigations:

Following investigations will be carried out.

1) Blood - Hb %

ESR

RBS

HBsAg

HIV

2) CT scan of Brain, if necessary.

Interventions:

Group – A:

o Mukhabhyanga with Karpasasthyadi Taila and Ksheerabaashpa sweda will be performed initially as Poorva Karma, and then Navana Nasya Karma with Karpasasthyadi Taila followed by appropriate Paschat karma will be done for 7 days followed by 14 days of Parihara Kala.

o After 14 days of Parihara Kala the same Navana Nasya procedure will be repeated with the same Taila for 7 days as mentioned above, after which 14 days of Parihara Kala will be followed again.

o During second course of Parihara Kala internally Ekangaveera Rasa 1-2 ratti (125-250mg) will be given along with Vidaryadi Kashaya as Anupana (60ml) twice daily after food will be administered as Shamanoushadhi for 21 days.

Group – B:

o Mukhabhyanga with Prasarinyadi Taila and Ksheerabaashpa sweda will be performed initially as Poorva Karma, and then Navana Nasya Karma with Prasarinyadi Taila followed by appropriate Paschat karma will be done for 7 days followed by 14 days of Parihara Kala.

o After 14 days of Parihara Kala the same Navana Nasya procedure will be repeated with the same Taila for 7 days as mentioned above, after which 14 days of Parihara Kala will be followed again.

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

YES

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] VIII. List of References:

1) Madhava Acharya. Madhava nidana. translated by K.R Sreekanda murthy. 8thedition. Varanasi: Choukambha orientalia; 2007 P. 84.

2) Vagbhata. Ashtanga Hridaya, Sarvanga Sundara Commentary of Arunadatta, Edit by Bhishagacharya Harisastri Paradakara Vaidya: 9thedition. Varanasi: Choukambha Surbharati; 2005 P. 533

3) Vagbhata. Ashtanga Hridaya, Sarvanga Sundara Commentary of Arunadatta, Edit by Bhishagacharya Harisastri Paradakara Vaidya: 9thedition. Varanasi: Choukambha Surbharati; 2005 P. 725

4) Agnivesha. Charakasamhitha. Translated by Vaidya Bhagavandash and Ram kumar Sharma. vol 3. 2nd edition Varanasi: Choukambha Sanskrit series office; 2001 P. 31

5) API text book of medicine. Edited by Sidharth n shash. The association of physicians of India: Mumbai; 2006 P.775

6) Kumarandclark clinical methord. Edited by Parveen kumar andMichael clark. London: Elsevier; 2009 P. 1107-1108

7) Davidson’s Principles and Practice of medicine. Edited by Nicholas Aboon, Nicki R Colledge, Brian R walker, John A A Huntur. 20thedition. London: Elsevier; 2009 P.-1249

8) Vagbhata. Ashtanga hridaya, Sarvanga Sundara Commentary of Arunadatta, Edit by Bhishagacharya Harisastri Paradakara Vaidya: 9thedition. Varanasi; Choukambha Surbharati; 2005 P. 287

9) Sarngadhara Samhita Adhamalla’s and Kasirama’s Gudhartha Dipika Commentary, By Pt.Sarngadharacharya, Edtd.by Parasurama Shastry, Vidyasagar, Chawkhambha Orientalia: Varanasi; 2004 P.-225

10) Sahasrayogam. Tailaprakaranam. Alappuzha: Vidyarambham Publications; P. 278

11) Vagbhata. Ashtanga hridaya, Sarvanga Sundara Commentary of Arunadatta, Edit by Bhishagacharya Harisastri Paradakara Vaidya: 9thedition. Varanasi; Choukambha Surbharati; 2005 P. 234.

12) Dattaraam Choube. Brihat Rasarajasundaram. 3rd Edition. Varanasi: Choukambha orientalia; 2000. P. 458.