TITLE OF STUDY:-  “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BRIHAT DASHAMOOLA TAILA NASYA AND SHATAHVADI  TAILA  NASYA  IN  THE  MANAGEMENT  OF  ARDHAVABHEDAKA  W.S.R  TO  MIGRAINE ’’

INTRODUCTION: 

 Ardhavabhedaka is one of the Shiro rogas mentioned by our Acharyas. Symptoms are like Ardha Parshwa shiro vedana, Pakshahath-Dashahath-Akasmath vedana, Bheda-todavath and Bhrama. It is mentioned as Tridosaja by Acharya Sushrutha, Vata/Vata-kaphaja by Acharya Charaka , and Vataja by Acharya Vagbhatta .

 Ardhavabhedaka can be compared to Migraine. Migraine –recurrent attacks of headache, varied in intensity, frequency, and duration; commonly unilateral in onset, and usually associated with anorexia and sometimes with nausea and vomiting. 

 According to International Headache Society (I.H.S), Migraine is the most common neurovascular headache. The life time prevalence of migraine is about 20% of females and 6% of males. The negative impact of migraines on quality of life, families and even work productivity is significant and often underrated as a serious complication. It is managed with NSAIDS, Triptans, ergot derivatives, anti-nausea drugs like Metaclopramide and cortico-steroids but, these are less acceptable due to their drawbacks and side-effects. Hence, this arise the need to explore an effective line of management for Migraine. 

Nasyakarma is selected in this study because nasa is the appropriate route to eliminate the doshas from the shiras and also Nasyakarma has mentioned in the management of Shiro rogas. 

For this condition, Brihat Dashamoola Taila and Shatahvadi taila have been selected for Nasya karma. All drugs of this taila are easily available and it is having qualities like katu, tikta, ushna,teekshna ,acts as urdhwabhaga dosha hara , vata-kapha hara and shulagna. 

Considering all these factors the study with above mentioned medicines are selected and entitled as “A comparative clinical study to evaluate the efficacy of Brihat Dashamoola Taila nasya and Shatahvadi taila Nasya in the management of Ardhavabhedaka w.s.r to Migraine.”

OBJECTIVES OF THE STUDY: 

1. To evaluate the efficacy of Brihat Dashamoola Taila Nasya in the management of Ardhavabhedaka. 

2. To evaluate the efficacy of Shatahvadi Taila Nasya in the management of Ardhavabhedaka. 

3. To compare the efficacy of Brihat Dashamoola Taila Nasya and Shatahvadi Taila Nasya in the management of Ardhavabhedaka. 

HYPOTHESIS : 

H0 : There is neither effect of Brihat Dashamoola Taila Nasya nor Shatahvadi Taila Nasya in Ardhavabhedaka. 

H1 : Brihat Dashamoola Taila Nasya has significant effect than Shatahvadi Taila Nasya in Ardhavabhedaka. 

H2 : Shatahvadi Taila Nasya has significant effect than Brihat Dashamoola Taila Nasya in Ardhavabhedaka. 

H3 : There is significant effect of both Brihat Dashamoola Taila Nasya and Shatahvadi Taila Nasya in Ardhavabhedaka. 

MATERIALS AND METHODS: 

1 SOURCE OF DATA: 

a) Subjects : 

Patients diagnosed with Ardhavabhedaka will be selected from O.P.D & I.P.D department of Shalakya tantra, R.P. Karadi ayurvedic hospital, ilkal  Bagalkot(dist) after applying the inclusion and exclusion criteria’s. 

b) Literary : 

Literary aspect of the study will be collected from classical ayurvedic and modern texts and updated journals. 

c) Selection of drugs : Brihat Dashamoola taila of Bhaishajya ratnavali reference and Shatahvadi taila of Yogarathnakara reference are used for the study. 

d) Collection of the drugs : The trial drugs required for the preparation of medicine will be collected from local areas with the proper authentication by Dravya Guna and Rasashastra and Bhaishajya Kalpana department of SVM Ayurveda and Medical college,Ilkal.

METHOD OF COLLECTION OF DATA:- 

 A) STUDY DESIGN:-  Randomized comparative clinical study 

 B) SAMPLE SIZE: - Total 30 patients were selected and divided into 2 groups i.e 15 patient’s each. 

 Group A- Minimum 15 patients will receive Brihat Dashamoola taila Nasya 

 Group B- Minimum 15 patients will receive Shatahvadi taila Nasya 

 C) DIAGNOSTIC CRITERIA:- As per the Classical clinical features of Ardhavabhedaka 

 1. Ardha murdha vedana (Severe pain in the half-side of head)

 2. Pakshath dashahath pravruthi (headache occurs within 15 days or 10 days)

 3. Bhrama (giddiness)

 4. Bheda todavath vedana (Splitting type/Pricking type of headache )

 D) INCLUSION CRITERIA:- Subjects fulfilling the following conditions 

 1. Patients suffering from classical signs and symptoms of Ardhavabhedaka. 

 2. Irrespective of gender, between the age group of 16 to 60 years. 

 3. Patients fit for Nasya karma. 

 E) EXCLUSION CRITERIA:- The following subjects will be excluded from the study : 

 1. Anya Shirorogas. 

 2. Any other systemic disorders which will interfere the course of treatment

STUDY DESIGN INTERVENTION:

GROUPS	SAMPLE SIZE	TREATMENT	DOSE	DURATION OF TREATMENT	FOLLOW-UP-PERIOD	TOTAL STUDY DURATION
Group-A	15 patients	Nasya with Brihat Dashamoola taila	8 bindu in each nostril	7 days	8th,15th , 22nd day	22 days
Group-B	15 patients	Nasya with Shatahvadi taila	8 bindu in each nostril	7 days	8th,15th , 22nd day	22 days

ASSESSMENT CRITERIA:- 

 Assessment of the condition was done based on detailed proforma adopting scoring methods of subjective parameters and objective parameters were analyzed based on the obtained data. 

 SUBJECTIVE PARAMETERS: 

 1. Theevratha of Ardhamoordha vedana (severity of headache) 

 2  Kala Prakarsha (Duration of headache) 

 3. Bhrama (giddiness)

 4. Hrillasa (Nausea) 

 5. Chardi (vomiting) 

 OBJECTIVE PARAMETERS: 

 1. Vega pravruthi (No of attacks of headache per month)