Clinical evaluation of an Ayurvedic therapy – SutashekharaRasa and Brihat Jeevakadya Taila Nasya in the management of Ardhavabhedaka (Migraine)

. Abstract Ardhavabhedaka- hemicranial headache is a psychosomatic disorder: later replaced by migraine a Greek word "half of the head" because the pain of migraine often occurs on one side(classical Migraine) may affect the entire head . The term "migraine" refers to a syndrome of vascular pathology of the cranial blood vessels and is one of the commonest headache encountered in clinical practise . The survey results suggested that both patients and physicians believe migraine treatment is elusive and that patients are becoming increasingly frustrated and dissatisfied with treatment outcomes disease;and Acharya Charaka opined that the vitiated Doshas after reaching Shirah vitiates Rakta ( Rasavaha and Raktavaha Srotas ) there to produce Shiro Roga (headache ). Its diagnosis is based on mainly clinical history . For the present study, it was planned to compare the result between Brihat Jeevakadhya Taila Nasya and Sutashekhara Rasa orally ( Pitashamaka, Raktashodhaka, Deepana etc .) in Treatment Trial group and Flunarizine in Control group . The overall effect of therapy showed that in Trial group 80 . 00% patients had marked improvement, followed by moderate improvement in 13 . 33% and complete improvement in 6 . 67% . In control group marked and moderate improvement was seen in 60 . 00% and 33 . 33% respectively; and 6 . 67% had mild improvement . No any adverse drug reaction was found during whole study . Total 30 patients were registered and from the results and observation which were received from this study it can be concluded that Trial group is showing better results in Ardhavabhedaka.

neurological disorders. The World Health Organization (WHO) has identified migraine among the world's top 20 leading causes of disability (1). More than 2/3rd of Migraine sufferers either have never consulted a doctor or have stopped doing so (2). Moreover routine use of these drugs leads to GI tract disturbance. In contrast to that Ayurveda has a variety of natural medication in the treatment of various varieties of Shirah-Shoola, and these recipes are free from above mentioned GIT complications and rather safe in use. Clinically, it is a Pitta dominant disease; and Acharya Charaka opined that the vitiated Doshas after reaching Shirah vitiates Rakta (Rasavaha and Raktavaha Srotas) there to produce Shiro Roga (headache)(3). Thus, Rakta is the main Dushya in Ardhavabhedaka. Its diagnosis is based on mainly clinical history. The study was conducted in I. P. G. T. & R. A., hospital. In this study, 30 patients were selected and Sutashekhara Rasa orally and Brihat Jeevakadhya Taila Nasya were given for its Pittashamaka, Raktashodhaka, Deepana etc. properties for 45days. For the present study, an attempt has been made to treat "the disease" by identifying the risk factors for the disease and preventing the recurrence of the disease in the individual by explaining Pathya Apathya.
For the present study it was planned to evaluate the efficacy of Brihat Jeevakadya Taila Nasya and SutashekharaRasain the management of Ardhavabhedaka.

Aims and objectives:
The present study was based on following aims and objects:

Group A-Trial group: (1)Brihat Jeevakadya Taila Nasya(4):
Nasya was done in the dose of 6 drops in each nostril for 2 sittings of seven days with the interval of 15 days after each sitting. Total duration was one and half month.
(2)Sutashekhara Rasa Vati (5): Vatiwas given in the dose of 250mg BD with DrakshajalaAnupana for one and half month. Drakshajala: 25 gm of dried Draksha is soaked in 200 ml of water overnight and in the next day morning, it is crushed and filtered through a clean cloth and that water is used as Anupana. (Anubhuta)

Group B-Control group:
Flunarizine Tab 10mg OD was given for 45 days. Patients were diagnosed on the basis of subjective criteria of diseases.

Investigations:
Routine hematological and urine analysis were carried out before treatment to rule out any systemic diseases. Scoring pattern:

Subjective symptoms
The improvement in patients was assessed on the basis of relief in the signs and symptoms of the disease. The details of the score adopted for the main signs and symptoms in this study are as follows: ❖ Severity of Headache 0 = No headache. 1 = Mild headache, patient is aware only if he/she pay attention to it. 2 = Moderate headache, can ignore at times. 3 = Severe headache, can't ignore but he/she can do his/her usual activities. 4 = Excruciating headache, can't do anything.

Overall assessment:
The improvement was assessed on the basis of subjective symptoms and salivary tests (objective parameters). Subjective: The assessment was done by adopting the following scoring pattern for subjective symptoms-1. Complete Remission: 100% relief in objective and subjective signs and symptoms. 2. Marked improvement: 76 -99% relief in objective and subjective signs and symptoms. 3. Moderate improvement: 51 -75% relief in objective and subjective signs and symptoms. 4. Mild improvement: 26 -50% relief in objective and subjective signs and symptoms. 5. Unchanged: Below 25% relief in objective and subjective signs and symptoms.

Statistical estimation of results:
The obtained data were analyzed statistically. The values were expressed as percentage of relief and Standard Error Mean. The data were analyzed by paired 't' test. Unpaired 't' test was applied for comparative study. P > 0. 05 = Insignificant P < 0. 05 and 0. 01 = Significant P < 0. 001 = Highly significant Regarding frequency, the episode at an interval of ≤ 5 days was seen maximum i. e., 80. 00%. Maximum patients (63. 33%) were found to be having continuous nature of headache. This shows that majority of the patients either have never consulted a doctor or have stopped doing so, which suggests the chronicity of disease. It was observed that patients rely on painkiller without any medical advice given by physician, in a hope to get rid of the headache quickly. But it was not going to stop the pathology. And the patients, who were taking anti-migraine drugs, were not responding. This results in chronic migraines i. e., rebound or transformed migraine headache.
The maximum Nidanas (etiological factors) observed in patients were Lavana-Amla Aahara (66. 67%), Samshana (50. 00%), Vishamashana (26. 67%), followed by Ratrijagarana 26. 67% and Diwaswapa 80. 00%. This shows faulty lifestyle, which is accepted by today's generation. Intake of junk food, taking food at any time, fasting habits of females, etc lead to Agnimandhya and Tridosha Dushti, which contributes chiefly in the pathogenesis of the disease. Also tyramine and other amines present in today's junk and sour-spicy food causes dilation of the nerves in the brain, resulting in a rush of blood. Faulty diet causes Constipation (23. 33%) and Hyperchlorhydria (70. 00%), which was observed by patients at the time of migraine headache.
Similarly Ratrijagarana and Diwaswapa aggravate Vata and Kapha Dosha respectively. Also disturbed sleep was observed in maximum patients i. e., 33. 33%. Disturbances such as sleep deprivation, too much sleep, poor quality of sleep and frequent awakening at night are associated with both migraine and tension headaches, whereas improved sleep habits helps in reducing the frequency of migraine headaches. Sleep also has been reported to shorten the duration of migraine headaches.
Sunlight was observed as maximum triggering factor i. e., 83. 33%. Bright lights and other high intensity visual stimuli can cause headaches in healthy subjects as well as patients with migraine headaches, but ISSN: 0976-5921 International Journal of Ayurvedic Medicine, 2015, 6 (2), 150-159 migraine patients seem to have a lower than normal threshold for light-induced pain. Sunlight, television and flashing lights all have been reported to precipitate migraine headaches.
Emotional (73. 33%) and physical stress (40. 00%) also acts as triggering factor. This may lead to Dhatukshaya and vitiation of Vata Dosha. Awakning/Journey (56. 66%) served as triggering factor because it also leads to vitiation of VataDosha. Skipping breakfast/fasting habbits (40. 00%) served as triggering factor because it possibly may precipitate migraine headaches by causing the release of stress-related hormones and lowering blood sugar.

Effect of therapies on signs & symptoms:
Regarding effect of therapy on Chief complaints, both the group showed significant results. Statistically highly significant (<0. 001) improvement in severity (81. 03%), duration (73. 46%) and frequency (75. 86%) of headache was obtained in trial group, followed by statistically highly significant (<0. 001) improvement in severity (66. 66%), duration (63. 41%) and frequency (61. 11%) of headache in Control group. Effect of therapy on other associated complaints showed that in trial group 95. 12% relief in Nausea, 82. 75% in Vomiting, 100% in Vertigo and 100% in Aura was obtained, which was statistically significant. While in Control Group, Nausea was relieved by 76. 66%, Vomiting by 94. 44%, and Vertigo by 63. 63%, which were statistically significant. But no significant result in Aura (<0. 05) was obtained. This shows that Trial group therapy was more effective than control group therapy on chief complaints. Total effect of therapy: The overall effect of therapy showed that in Trial group 80. 00% patients had marked improvement, followed by moderate improvement in 13. 33% and complete improvement in 6. 67%. In control group marked and moderate improvement was seen in 60. 00% and 33. 33% respectively; and 6. 67% had mild improvement. Not a single case was noted unchanged in any of the groups. FIGURE NO. 2

Probable Mode of action:
In the present study Sutashekhara Rasa used for systemic treatment of Ardhavabhedaka. SutashekharaRasa is mentioned in Yogratnakara for Amlapitta rogadhikara. The compound was slightly modified to meet the cost factor i. e. Swarna Bhasma was replaced by Swarna Makshika Bhasma (6). In Ardhavabhedaka, the root cause is Agnimandhya. So if Agnimandhya is treated, best production of Rasa-Rakta Dhatu occurs. We can't establish that the particular drug acts by their Rasa, Guna, Virya, Vipaka mentioned in Yoga.

Probable mode of action of Brihat Jeevakadya Taila Nasya
There are various modalities for the alleviation of Shirahshoola. According to Acharya Charaka, Nasyakarma is the best treatment for the Shiro Roga(10), because, nose is the nearest pathway for the elimination of Doshas from the head. Ardhavabhedaka being one of the Shiroroga can be best treated with Nasya in which morbid Doshas are situated in the head. In the present study Brihat Jeevakadya Taila used for Nasya for treatment of Ardhavabhedaka. Brihat Jeevakadya Taila is indicated in Chakradutta forVata-Pittaja Shirahshoola. Jeevaka and Rishabhaka will be representad by Vidarikanda due to it's unavailability.

Importance of Snehana Nasya
Nasya is the only procedure which can directly influence Pranadhisthan and Indriya(11):

Image No 2:
Dravyas in Taila Paka are Mrudupaka (12) Biphasic nature of this type of process (Mrudupaka) i. e. 1. Aqueous soluble part of active principle will be easily absorbed through mucosa.